PPRU Studies

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Protocol TitleStudy PILead SiteDrug NameTherapeutic Area
A 12 week double-blind randomized trial, with a 12 week open-label extension, to investigate the efficacy and safety of meloxicam oral suspension administered once daily and naproxen oral suspension administered twice daily in children with Juvenile Rheumatoid Arthritis CHOP Meloxicam Anti-inflammatory
A 12 week, Multi-Center, Double-Masked,Parallel Group, Primary Therapy Study of the Safety and Efficacy of BEXTAXON 0.5% Compared to AZOPT 1% in Pediatric Patients with Glaucoma or Ocular Hypertenstion. Link to matching the protocol in clinicaltrial.gov Jacob Aranda, M.D. Wayne BETAXON Antihypertensives
a 12-week active-cmparator-controlled trial to evaluate the efficacy and safety of rofecoxib for treatment of Juvenile Arthritis Susan Blaney, M.D. Baylor Rofecoxib Analgesics
A 2-week, randomized, double-blind, parallel-group study in pediatric subjects with asthma aged 4 to 11 years to examine the pharmacokinetics of fluticasone propionate (FP) and Samlmeterol (SALM) from the FP/SALM combination product administered twice dai Michael Christensen Utenn fluticasone propionate/salmeterol Anti-inflammatory
A bioavailability study of suspension formulation of ibuprofen/pseudophedrine hydrochloride/chlorphenirmine maleate in allergy-symptomatic children 6 to 11 years of age AR-00-03 Walson, Philip Cincinnati Ibuprofen/ Pseudoephedrine Hydrochloride/ Chlorpheni Antihistamines
A companion extension study to evaluate the long-term safety of daily, single, subcutaneous injections of r-metHu1L-1ra (Anakinra) in subjects with polyarticular-course juvenile rheumatoid arthritis who participate in IL-1ra Protocol 990758 Link to matching the protocol in clinicaltrial.gov Moynes, Barry Baylor Anakinra Antirheumatic agents
A dose escalation, randomized double-blind withdrawal study of the efficacy, dose-response and safety of ramipril for the treatment of hypertension in children and adolescents- K726-01-4002 Link to matching the protocol in clinicaltrial.gov Kevin Meyers, MD CHOP Ramipril Antihypertensives
A double Blind Placebo controlled, Virologic Efficacy Trial of Pleconaril in the Treatment of infants with Enteroviral Meningitis James Connor, M.D. UCSD Pleconaril Anti-infectives
A double-blind, placebo-controlled, PK, PD evaluation of ranitidine in four-to-eleven year old subjects with suspected abnormal acid reflux. Cleveland Ranitidine GI drugs
A Double-Blind, Placebo-Controlled, Virologic Efficacy Trial of Pleconaril (VP63843) in the Treatment of Neonates with Enteroviral Sepsis Syndrome (CASG 106). James Connor, M.D. UCSD Pleconaril Anti-infectives
A Double-Blind, Randomized Dose Response Study of Enalapril in Children with Hypertension Thomas Wells, M.D. Arkansas Enalapril Antihypertensives
A multicenter phase I/II study to determine antibody concentrations and to assess the safety of administration of IHN-AH21, a donor-selected human staphylococcal immune globulin in low birthweight infants Brady, Michael Columbus IHN-A21 Anti-infectives
A Multicenter Study of Single Escalating DoseSafety and Pharmacokinetics of Oral Fexofenadine Hydrochloride in Children from 6 months to 2 Years of Age Gregory L. Kearns KansasCity Fexofenadine Hydrochloride Antihistamines
A Multi-Center Study of the Safety, Tolerability, Pharmacokinetics, and Dose Escalation of Intravenous Recombinant Human Mannose-Binding-Lectin (rhMBL) in MBL Deficient Pediatric Hematology/Oncology Patients with Fever and Neutropenia Link to matching the protocol in clinicaltrial.gov Theokolis Zaoutis, MD CHOP Recombinant Human Mannose-Binding-Lectin
A multicenter study to Evaluate the efficay, safety, and pharmocokinetics of Brevibloc for the treatment of Hypertension in Infants and Children after surgical repair of Coarctation of the Aorta Protocol No. 20,015-04 Sarah Tabbutt, M.D. CHOP Esmolol Hydrochloride Anti-arrhythmics
A Multicenter, Double-Blind, Randomized, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of Caspofungin Versus ( Amphotericin B ) Liposome for Injection as Empirical Therapy in Pediatric Patients With Persistent Fever and Neutropenia- Link to matching the protocol in clinicaltrial.gov Anne Reilly, MD CHOP Caspofungin Anti-infectives
A Multi-center, In-patient, Open-label, Dose-Ranging Study to Characterize the Pharmacokinetics and Safety of an Oral Liquid Formulation of Oxycodone in Patients from Birth to 4 years of age Who Require Opioid Analgesia - Protocol # OXP1005 Galinkin, Jeffrey CHOP Oxycodone Analgesics
A multicenter, long-term, active surveillance study of musculoskeletal disorders that occur after initiating a course of levoflocacin (RWJ-25213-097) or non-fluoroquinolone therapy for active infectious diseases in children who were enrolled in phase thre Bocchini, Joseph LSUniv Levofloxacin Anti-infectives
A Multi-center, Open Label Pharmacokinetic Study of Fluconazole in Infants Link to matching the protocol in clinicaltrial.gov Kelly Wade, MD, PhD CHOP Fluconazole Anti-infectives
A multicenter, open, sequential dose-escalation study to investigate the safety, tolerability and pharmacokinetics of two seperate doses of MK-0991 in children with new onset fever and neutropenia PROTOCOL No.: 033-00 Peter Adamson, M.D. CHOP MK-0991 Anti-infectives
A Multicenter, Open, Sequential Dose-Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of 2 Separate Doses of Caspofungin Acetate in Children Between the Ages of 3 to 24 Months With New Onset Fever and Neutropenia-042 Link to matching the protocol in clinicaltrial.gov Peter C. Adamson, MD CHOP Caspofungin Acetate Anti-infectives
A MULTICENTER, OPEN-LABEL PHARMACOKINETIC, PHARMACODYNAMIC, CLINICAL SYMPTOMS, AND SAFETY STUDY OF PANTOPRAZOLE DELAYED RELEASED GRANULES ADMINISTERED AS A SUSPENSION IN NEONATES AND PRETERM INFANTS WITH A CLINICAL DIAGNOSIS OF GASTROESOPHAGEAL REFLUX DIS Link to matching the protocol in clinicaltrial.gov John van den Anker CNMC Pantoprazole GI drugs
A multi-center, open-label, active-controlled, dose-titration study evaluating the safety, efficacy and pharmacokinetics of Oxybutynin transdermal systems in the treatment of Detrusor overactivity associated with a neurological condition in pediatric pati Link to matching the protocol in clinicaltrial.gov Cartwright Utah Oxybutynin GU drug
A Multicenter, Open-Label, Noncomparative Study to Evaluate the Safety, Tolerability, and Efficacy of Caspofungin Acetate in Children with Documented Candida or Aspergillus Infections-043 Link to matching the protocol in clinicaltrial.gov Theoklis Zaoutis, MD CHOP Caspofungin Acetate Anti-infectives
A multicenter, open-label, single and multiple dose pharmacokinetic study of intravenous Pantoprazole in preterm infants and infants 0-11 months with a clinical diagnosis of gastroesophageal reflux disease (GERD) or the need for Acid Suppression Link to matching the protocol in clinicaltrial.gov Angela Jeffries, M.D Louisville Pantoprazole GI drugs
A multicenter, open-label, single dose study to evaluate the pharmacokinetics of valsartan given as an oral suspension in pediatric and adolescent subjects 2 months to 16 years of age with hypertension Wilson, John LSUniv Valsartan Antihypertensives
A Multicenter, Open-Label, Single-Arm Study to Evaluate the Single Dose Pharmacokinetics and Safety of Famciclovir after Administration of Famciclovir oral Pediatric Formulation to Infants 1 Month of Age to <1 Year of Age with Herpes Simplex or Varicella Link to matching the protocol in clinicaltrial.gov Jeffrey L. Blumer, Ph.D., M.D. Cleveland Famciclovir Anti-infectives
A multicenter, open-label, single-arm, two-step study to evaluate the safety and single-dose pharmacokinetics of famciclovir and multiple-dose safety after administration of famciclovir oral pediatric formulation of children 1 to 12 years of age with herp Link to matching the protocol in clinicaltrial.gov Gerber Cincinnati Famciclovir Anti-infectives
A Multicenter, Open-Label, Single-Dose Study to Evaluate the Plasma Concentration-Time Profile and Tolerability of a 5.25 mg Intravenous Dose of Montelukast (SINGULAIR™) in Children Aged 6 to 14 years With Asthma. Kearns KansasCity Montelukast Anti-inflammatory
A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel study of The Efficacy and Safety of Metformin Hydrochloride for the Treatment of Adolescents with Type II Diabetes Mellitus JAMES D. CONNOR, M.D. UCSD METFORMIN Antidiabetic agents
A Multicenter, Randomized, Observer Blinded Clinical Trial to Determine the Overall Safety of Lorazepam Administered as a Continuous Infusion or Intermittent Boluses, and Midazolam Administered as a Continuous Infusion for Sedation of Critically Ill, Mech Link to matching the protocol in clinicaltrial.gov Jeffrey Blumer, MD, PhD Cleveland Lorazepam Sedatives
A multicenter, randomized, open label, parallel study of the PK, safety, and efficacy of Metformin Hydrochloride plus Insulin compared to Insulin Monotherapy for treatment of adolescent with Type 2 Diabetes Mellitus. JAMES D. CONNOR, M.D. UCSD METFORMIN Antidiabetic agents
A Multicenter, Randomized, Open Label, Single And Multiple Dose Study Of The Pharmacokinetics And Pharmacodynamics Of 2 Dose Levels Of Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants Aged 1 Through 11 Months With Presumed GERD 3001B3-333 Link to matching the protocol in clinicaltrial.gov Van Den Anker CNMC PANTOPRAZOLE GI drugs
A Multicenter, Randomized, Open Label, Single And Multiple Dose Study Of The Pharmacokinetics And Pharmacodynamics Of 2 Dose Levels Of Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants Aged 1 Through 11 Months With Presumed GERD 3001B3-333 Link to matching the protocol in clinicaltrial.gov Van Den Anker CNMC PANTOPRAZOLE GI drugs
A Multicenter, Randomized, Open Label, Single, And Multiple Dose Study Of The Safety And Pharmacokinetics Of 2 Dose Levels Of Pantoprazole Sodium In Children Aged 1 Through 11 Years With Endoscopically Proven GERD Link to matching the protocol in clinicaltrial.gov van den Anker CNMC Pantoprazole sodium GI drugs
A multicenter, randomized, open-label, single and multiple-dose study of the pharmacokinetics and safety of two dose levels of pantoprazole sodium tablets in adolescents aged 12 through 16 years with a clinical diagnosis of GERD (3001A3-337-US, pantoprazo Link to matching the protocol in clinicaltrial.gov Laura James Arkansas Pantoprazole GI drugs
A multicenter, rater-blind randomized, age-stratified, parallel-group study comparing two doses of oxcarbazepine as monotherapy in pediatric patients with inadequately-controlled partial seizures (2339) Link to matching the protocol in clinicaltrial.gov Wilfong, Angus Baylor Ozycarbazepine Anticonvulsants
A multicenter, rater-blind, randomized, age-stratified, parallel-group study comparing two doses of oxcarbazepine as adjunctive therapy in pediatric patients with inadequately-controlled partial seizures Link to matching the protocol in clinicaltrial.gov Wilfong, Angus Baylor Oxycarbazepine Anticonvulsants
A pediatric Pharmacokinetic Study of Cerebrospinal Fluid(CSF) Penetration of Intravenous Quinupristin-Dalfopristin(Synercid) Peter C. Adamson, M.D. CHOP Quinupristin-Dalfopristin Anti-infectives
A Pharmacokinetic and Safety Study of Single and Multiple Doses of Rabeprazole in Pediatric Subjects with GERD 1 to 11 Years Old, Inclusive RABGRD1002 Link to matching the protocol in clinicaltrial.gov Ali Bader, MD CNMC Rabeprazole GI drugs
A Pharmacokinetic Study of Actinomycin-D in Children with Cancer Link to matching the protocol in clinicaltrial.gov Peter Adamson, MD, Jeffrey Skolnik, MD CHOP Actinomycin-D Anti-infectives
A Pharmacokinetic Study of Dexmedetomidine in Infants Link to matching the protocol in clinicaltrial.gov Athena Zuppa, MD CHOP Dexmedetomine Sedatives
A pharmacokinetic study of valacyclovir in pediatric oncology patients Link to matching the protocol in clinicaltrial.gov Lisa Bomgaars, MD Baylor Valacyclovir Anti-infectives
A pharmacokinetic study to determine the oral bioavailability of methotrexate in patients with inflammatory bowel disease Link to matching the protocol in clinicaltrial.gov Michael Stephens, M.D. CHOP Methotrexate Immunosuppressant
A Pharmacokinetic, Pharmacodynamic and Safety Study of Single and Multiple Doses of Rabeprazole in Pediatric Subjects with GERD 1 to 11 Months Old, Inclusive Protocol RABGRD1003 Link to matching the protocol in clinicaltrial.gov Ali Bader, MD CNMC Rabeprazole GI drugs
A pharmacokinetic/ pharmacodynamic study of CD45 and CD52 monoclonal antibodies Malcolm Brenner, M.D. Baylor N/A Non-therapeutic
A pharmacokinetic/pharmacodynamic and safety evaluation of oseltamivir (Tamiflu®) for the treatment of children less than 24 months of age with confirmed influenza infection Link to matching the protocol in clinicaltrial.gov Pablo Sanchez, MD UTSW oseltamivir (Tamiflu®) Anti-infectives
A Phase 1 Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates; Protocol Number: 9463-CL-2104 Link to matching the protocol in clinicaltrial.gov Danny Benjamin Duke Micafungin Anti-infectives
A Phase 1, Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin (FK463) in Infants and Toddlers (¡Ý 4 Months to < 24 Months of age) With Esophageal Candidiasis or Other Invasive Candidiasis Protocol Number: 9463-CL-21 Link to matching the protocol in clinicaltrial.gov Danny Benjamin MD Duke Micafungin Anti-infectives
A Phase 1, Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin (FK463) in Children (2-5 Years and 6-11 Years) and Adolescents (12-16 Years) with Esophageal Candidiasis or Other Invasive Candidiasis; Protocol Number: 9463-CL-210 Link to matching the protocol in clinicaltrial.gov Danny Benjamin, MD PhD Duke Micafungin Anti-infectives
A Phase 1/2, Open-Label, Repeat-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of MEDI-524, A Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), at Risk for Ser Link to matching the protocol in clinicaltrial.gov Hasan S. Jafri, M.D. UTSW MEDI-524 Numax Anti-infectives
A Phase 3 Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Adefovir Dipivoxil in Children and Adolescents (Age 2 to <18) with Chronic Hepatitis B Link to matching the protocol in clinicaltrial.gov Parvathi Mohan, MD CNMC Adefovir Dipivoxil Anti-infectives
A Phase 3 Randomized, Double-Blind, Multicenter Study to Compare the Efficacy and Safety of Micafungin with Amphotericin B Deoxycholate for the Treatment of Neonatal Candidiasis Link to matching the protocol in clinicaltrial.gov Benjamin Duke micafungin Anti-infectives
A Phase I Escalation Study of Sodium Phenylbutyrate in Pediatric subjects with type I Spinal Muscular Atrophy (SMA) Link to matching the protocol in clinicaltrial.gov Susan Iannaccone UTSW Sodium Phenylbutyrate
A Phase I Escalation Study of Sodium Phenylbutyrate in Pediatric subjects with type II/III Spinal Muscular Atrophy (SMA) Link to matching the protocol in clinicaltrial.gov Susan Iannaccone UTSW Sodium Phenylbutyrate
A phase I, randomized, open-label, multi-national study to evaluate the pharmacokinetics of repeated once-daily intravenous doses of esomeprazole in paediatric patients 0 to 17 years old, inclusive Link to matching the protocol in clinicaltrial.gov Gregory L. Kearns, Pharm.D.,Ph.D KansasCity Esomeprazole GI drugs
A Phase I, Randomized, Placebo-Controlled Trial to Assess the Pharmacokinetics and Tolerability of a Single Dose of Torcetrabib/Atorvastatin Fixed Combination Administered to Children and Adolescent Subjects with Heterozygous Familial Hypercholesterolemia Connor UCSD Torcetrapib/ Atorvastatin Other
A phase I/II , open label, dose escalating pharmacokinetic, pharmacodynamic (urodynamic) and clinical effect, and safety study of tolterodine PR capsules in children with detrusor hyperreflexia, 11 to 15 years of age (Protocol NO: 583E-URO-0581-003) Aranda Wayne Tolterodine GU drug
A phase I/II, open label, dose escalating pharmacokinetic, pharmacodynamic (urodynamic) and clinical effect, and safety study of tolterodine liquid in children with detrusor hyperreflexia, aged 1 month to 4 years of age (Protocol NO: 583E-URO-0581-001) Aranda Wayne Tolterodine GU drug
A phase I/II,open-label, dose escalating pharmacokinetic, pharmacodynamic (urodynamic) and clinical effect, and safety study of tolterodine liquid in children with detrusor hyperflexia, 5 to 10 years of age (Protocol NO:583E-URO-0581-002) Aranda Wayne Tolterodine GU drug
A Phase II Multicenter, Randomized, Double-Blind, Parallel Group, Dose-Ranging, Effect-Controlled Study to Determine the Pharmacokinetics and Pharmacodynamics of Sodium Nitroprusside (SNP) in Pediatric Subjects Link to matching the protocol in clinicaltrial.gov Scott Schulman, MD Duke Sodium Nitroprusside Vasodilators
A phase II, global, multicenter, double-blind, randomized, placebo-controlled, dose-ranging trial evaluating two dosing regimens of RI-001 (RespImmune) in RSV infected patients at risk of severe RSV (Respiratory Syncytial Virus) illness Link to matching the protocol in clinicaltrial.gov Octavio Ramilo, MD UTSW RSV-IVIG (RI-001) Anti-infectives
A phase II, open-label study of clofarex in pediatric patients with refractory or relapsed acute lymphoblastic leukemia-CLO-212-A2 Rheingold, Susan CHOP Clofarex Anti-inflammatory
A phase II, Open-Label study of clofarex in pediatric patients with refractory or relapsed acute myelogenous leukemia. Rheingold, Susan CHOP Clofarex Anti-inflammatory
A phase I-II, open-label, multi-center trial to determine the dosimetry and safety of technetium Tc99m sestamibi in pediatric subjects Stephen Paridon, M.D. CHOP Technetium Tc99m Sestamibi
A Phase IV, Open-Label, Study of the Safety and Antiemetic Effect of 0.15 mg/kg Intravenous Odansetron Hydrochloride Administered for Three Doses to Pediatric Cancer Patients Age 6 Months to 48 Months Who are Receiving Moderately to Highly Emetogenic Chem Galinkin, Jeffrey, MD CHOP Ondansetron Hydrochloride Anti-emetic
A Pivotal Phase 3 Study of MEDI-524 (Numax), an Enhanced Potency Humanized Respiratory Syncytial Virus (RSV) Monoclonal Antibody, for the Prophylaxis of Serious RSV Disease in High-Risk Children. Link to matching the protocol in clinicaltrial.gov Hasan Jafri, MD UTSW MEDI-524 (Numax) Anti-infectives
A Prospective, Multi-Center, Randomized, Open-Label, Single and Repeated Dose, 48 Hour Study of Intravenous Acetaminophen in Pediatric Inpatients to Determine Pharmacokinetics and Safety and Efficacy in Acute Pain and Fever Athena Zuppa, MD CHOP Acetaminophen Analgesics
A Prospectively Randomized, Double-blind, Comparative Multicenter Study to Evaluate Efficacy and Safety of Nyotran and Amphotericin B for Empiric Antifungal Treatment of Neutropenic Patients Alan Gamis, MD KansasCity Nyotran vs AmphoB Anti-infectives
A randomized (2:1), stratified, double-blind, parallel-group, placebo-controlled, 12-week, multicenter trial of fluticasone propionate HFA inhalation aerosol 88mcg BID verses placebo HFA delivered via an MDI and a valved holding chamber with facemask in p Christensen, Michael Utenn Fluticasone propionate Anti-inflammatory
A randomized controlled comparison of ketorolac tromethamine and morphine for postoperative analgesia in critically-ill, 3-18 year-old children: A subgroup analysis of developmental changes in morphine kinetics and efficacy Robert M. Ward, MD Utah Morphine Analgesics
A Randomized Study of Daily vs. High-dose Weekly Prednisone Therapy in Duchenne Muscular Dystrophy Link to matching the protocol in clinicaltrial.gov Diana Escolar, MD CNMC Prednisone Anti-inflammatory
A randomized, double-blind trial of anti-TNF alpha chimeric monoclonal antibody (infliximab) in combination with methotrexate for the treatment of patients with polyarticular juvenile rheumatoid arthritis Moynes, Barry Baylor Methotrexate, infliximab Antirheumatic agents
A randomized, double-blind, parallel group study to determine the effective duration (1, 2 or 4 weeks) and safety of Lamisil® (tablets) given once daily to patients with tinea capitis due to Trichophyton species (mainly T. Tonsurans). JAMES D. CONNOR, M.D. UCSD Lamisil Anti-infectives
A Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy of Asacol® (1.2 to 4.8 g/day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents with Mildly-to-Moderately Active U Link to matching the protocol in clinicaltrial.gov Ali A. Bader, MD CNMC Asacol (mesalamine) Anti-inflammatory
A randomized, double-blinded, placebo-controlled study of the antipyretic efficacy and safety of a single administration of 30mg/Kg fo i.v. propacetamol in children age 3 to 12 years with acute fever of infectious origin. Walson Columbus propacetamol Antipyretics
A randomized, multi-center, blinded, placebo-controlled study with an open-label run-in period to evaluate the efficacy, safety, and pharmacokinetics of daily, single, subcutaneous injections of r-metHuIL-1ra (Anakinra) in polyarticular-course juvenile rh Link to matching the protocol in clinicaltrial.gov Moynes, Barry Baylor Anakinra Antirheumatic agents
A randomized, multicenter, open label, phase II study to evaluate the safety, tolerability, pharmacokinetics and the effects on liver iron concentration of repeated doses of 10 mg/kg/day of ICL670 relative to deferoxamine in sickle cell disease patients w Link to matching the protocol in clinicaltrial.gov Brigitta Mueller, MD Baylor ICL670 Chelator
A randomized, multicenter, placebo-controlled parallel group study of four months duration per patient to evaluate the safety and efficacy of treatment with 24 ug b.i.d. and 12 ug b.i.d formoterol, double-blind, and 12 ug b.i.d formoterol with additional Jones, Kimberly LSUniv Formoterol fumarate
A randomized, open-label study of the pharmacokinetics, safety and tolerability of a single dose of ramipril in infants, children and adolescents from 1 month to 16 years of age- K726-01-4001 Kevin Meyers, MD CHOP Ramipril Antihypertensives
A randomized, open-label, multicenter study with open-label extension of the pharmacokinetics and safety of topiramate as the oral liquid and sprinkle formulations as an adjunct to concurrent anticonvulsant therapy in infants (aged 1 to 23 months, inclusi Glauser, M.D. Cincinnati Topiramate Anticonvulsants
A randomized, open-label, multi-center, phase II study to evaluate the safety and efficacy of oral ICL670 (deferasirox) 20 mg/kg/day relative to subcutaneous deferoxamine in sickle cell disease patients with iron overload from repeated blood transfusions. Link to matching the protocol in clinicaltrial.gov Caterina Minniti, MD CNMC ICL670 Chelator
A randomized, single-blind, dose-rising, placebo-controlled, crossover study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of Exenatide in adolescent subjects with Type 2 Diabetes Melitus, Amylin Protocol 2993-124 Link to matching the protocol in clinicaltrial.gov Capparelli UCSD Exenatide Antidiabetic agents
A single dose, single-blind, pharmacokinetic study of 2.5 mg or 5.0 mg ridogrel tablets in clinically stable, non-active, ulcerative colitis pediatric patients age ≥8 to <18. Kearns KansasCity Ridogrel GI drugs
A single-dose bioavailability study of a suspension formulation of ibuprofen, pseudoephedrine and dextromethorphan in children 2 to less than 12 years of age with symptoms of the cold or flu Capparelli, Edmund UCSD Ibuprofen, pseudophedrine, dextromethorphan Anti-inflammatory
A single-dose pharmacokinetic study of 0.03 mg/kg R108512 solution in pediatric subjects, ages ≥ 4 to ≤ 12 years, with functional fecal retention (FFR) PRU-USA-12 Greg Kearns, Pharm. D. KansasCity Prucalopride GI drugs
A single-dose, ascending dose study to characterize the pharmacokinetics of intravenous tigacycline in children Gregory Kearns, PharmD, PhD KansasCity Tigecycline Anti-infectives
A single-dose, open-label study evaluating the pharmacokinetics of an oral memantine HCl modified-release formulation in pediatric patients with autistic-spectrum disorders (MEM-PK-21) Gregory L. Kearns, Pharm.D., Ph.D KansasCity memantine
A Six-Month, Multi-Center, Open-Label Study to Assess the Safety and Efficacy of Oral Glycopyrrolate Liquid for the Treatment of Pathologic (Chronic Moderate to Severe) Drooling in Pediatric Patients 3 to 18 Years of Age with Cerebral Palsy or other Neuro Link to matching the protocol in clinicaltrial.gov Philip Walson, MD Cincinnati glycopyrrolate
A study of Pharmokinetics, Safety, and Tolerability of a single dose of pantoprazole in Children Gregory L.Kearns, Pharm. D. KansasCity Pantoprazole GI drugs
A study of the PK of quinapril in pediatric patients Jeffrey Blumer, M.D. Cleveland Quinapril Antihypertensives
Absorption and Metabolism of Oral Codeine in Mechanically Ventilated Neonates J.V. Aranda, M.D., PhD Wayne Codeine Analgesics
An Efficacy, Safety and Tolerability Study of Daily Dosing with Levalbuterol, Racemic Albuterol and Placebo in Pediatric Subjects 2-5 Years old with Asthma. Stanley J. Szefler, M.D. NJMed Levalbuterol Antihypertensives
An Evaluation Of The Pharmacokinetic Profile And Safety Of A Single Dose Of Daptomycin In Pediatric Subjects Aged Two To Six Years Who Are Concurrently Receiving Standard Antibiotic Therapy For Proven Or Suspected Gram-Positive Infection Jeffrey L. Blumer, Ph.D., M.D. Cleveland Daptomycin Anti-infectives
An evaluation of the pharmacokinetics of a single dose of daptomycin (4mg/kg) in pediatric patients aged two to sixteen years who are concurrently receiving standard antibiotic therapy for proven or suspected gram-positive infections Link to matching the protocol in clinicaltrial.gov Kearns KansasCity Daptomycin Anti-infectives
An Evaluation of the Safety, Efficacy and Pharmacokinetics of Daptomycin in Pediatric Subjects Aged Seven to Seventeen Years With Complicated Skin and Skin Structure Infections Caused by Gram-Positive Pathogens Link to matching the protocol in clinicaltrial.gov Jeffrey L. Blumer, Ph.D., M.D Cleveland Daptomycin Anti-infectives
An initial study of the pharmacokinetics, pharmacodynamics, safety and tolerability of intravenous doses of pantoprazole in hospitalized pediatric patients. Protocol 3001K1-110-US James D Marshall, MD KansasCity Pantoprazole GI drugs
An Open Intravenous Study to Evaluate the Plasma Concentration Profiles of MK-0826 in Patients Aged 3 Months Through 17 Years. Blumer Cleveland MK-0826 Anti-infectives
An open label evaluation of the pharmacokinetics and safety of a single 10 mg/kg dose of intravenously administered azithromycin in pediatric patients Kearns, Greg KansasCity Azithromycin Anti-infectives
An Open Label Evaluation of the Pharmacokinetics and Safety of a Single Dose Intravenous Azithromycin in Preterm Neonates Link to matching the protocol in clinicaltrial.gov J. V. Aranda, MD, PhD Wayne Azithromycin Anti-infectives
An open label single dose study to evaluate the safety and pharmacokinetics of levofloxacin(RWJ-25213) in Children from the ages of 8-16years. Tom Wells, M.D Arkansas Levofoxacin Anti-infectives
An Open Label Single Intravenous Dose Study to Evaluate the Safety and Pharmacokinetics of Levofloxacin in Infants and Children (6 months - 12 years of age) Wells, Thomas G. Arkansas Levofloxacin Anti-infectives
An Open Label Study to Describe the Pharmacokinetics of Cefazolin in Preterm Neonates P. Brian Smith MD, MHS Duke Cefazolin Anti-infectives
An Open Label Study to Further Describe the Pharmacokinetics of Micafungin in Neonates Link to matching the protocol in clinicaltrial.gov Brian Smith Duke Micafungin Anti-infectives
An open label, randomized, parallel, multicenter pharmacokinetic (PK) and pharmacodynamics (PD) study of Axid® (Nizantidine) in pediatric subjects age 5 days -12 years with gastroesophageal reflux (GER) symptoms Connor, James UCSD Axid GI drugs
An Open Label, Single Dose, Dose Rising, Multi-center Study to Assess the Tolerability and Pharmacokinetics of Ropinirole Immediate Release in Adolescents with RLS Link to matching the protocol in clinicaltrial.gov Greg Kearns, PharmD, PhD KansasCity Ropinirole Dopamine receptors agonists
An Open-Label Pilot Study of Pentoxifylline in Steroid-Naive Duchenne Muscular Dystrophy Link to matching the protocol in clinicaltrial.gov Diana Escolar, MD CNMC Pentoxifylline Vasodilators
an open-label study of the single-dose pharmacokinetics of Olmesartan Medoxonil in pediatric patients with hypertension Link to matching the protocol in clinicaltrial.gov Thomas Wells, MD Arkansas Olmesartan Medoxomil Antihypertensives
An Open-Label Study to Investigate the Pharmacokinetics of Enalapril in Hypertensive Children and Infants Thomas Wells, M.D. Arkansas Enalapril Antihypertensives
An open-label, intravenous oral switch, multiple dose, multi-centre study to investigate the pharmacokinetics, safety and tolerability of voricanozole in the hospitalized children aged 2 < 12 years who require treatment for prevention of systemic fungal i Link to matching the protocol in clinicaltrial.gov Peter Adamson, M.D. CHOP Voriconazole Anti-infectives
An open-label, multicenter, multiple-dose study to evaluate the pharmacokinetics of terbinafine(LAMASIL) in children 4-8 years of age with tinea capitis Susan Abdul-Rahman, PharmD KansasCity Terbinafine Anti-infectives
An open-label, multi-center, phase 4 study to evaluate the safety, efficacy and pharmacokinetics of optimark® (Gadoversetamide Injection) in Pediatric Patients ( 2 to 22 and 12 to 16 years of age) referred for contrast-enhanced magnetic resonance imaging Link to matching the protocol in clinicaltrial.gov Jacob Aranda, MD Wayne OptiMARK Non-therapeutic
An open-label, multicenter, PK study to evaluate the bioavailability of a single dose of omeprazole in a pediatric population. Philip Walson, M.D. Columbus Omeprazole GI drugs
An open-label, multicenter, PK study to evaluate the bioavailability of single and multiple doses of omeprazole in a pediatric population Laura James, M.D. Arkansas Omeprazole GI drugs
An open-label, multi-center, repeated dose pharmacokinetic study of 20, 40 and 60 mg/kg/day of Levetiracetam in children (4-12 years of age, inclusive) with partial onset seizures Kearns, Gregory KansasCity levetiracem Anticonvulsants
An open-label, multicenter, single dose study to evaluate the pharmacokinetics of glimepride (Amaryl®) in pediatric patients with type 2 diabetes mellitus Connor, James UCSD Glimepiride (Amaryl) Antidiabetic agents
An Open-Label, Parallel-Group, Single- and Multiple-Dose, Pediatric Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Carisbamate as Adjunctive Therapy in Children and Adolescents With Epilepsy, Aged 4 to 15 Years, Inclusive, Followed by JV Aranda, MD, PhD Wayne Carisbamate Anticonvulsants
An open-label, randomized, non-inferiority study of novel erythropoiesis stimulating protein (NESP) and recombinant human erythropoietin (rHuEPO) for treatment of anemia in pediatric subjects with chronic renal insufficiency (CRI) or end-stage renal disea Jacob Aranda, M.D. Wayne NESP Blood modifiers
An Open-Label, Repeat Dose, Multicenter Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Doses to Intranasally Administered Triamcinolone Acetonide (Nasacort® AQ) in Pediatric Allergic Rhinitis Patients 2 to 5 Years of Age Compared James D. Connor M.D UCSD Nasacort AQ Anti-inflammatory
Antigenic Biomarker Identification of Acetaminophen Hepatotoxicity in Children. Laura James, MD Arkansas N/A Analgesics
Antimicrobial Pharmacokinetics in High Risk Infants Link to matching the protocol in clinicaltrial.gov Danny Benjamin Duke 10 antimicrobial agents Anti-infectives
Antiretroviral Drugs in Breastmilk: Population PK Models James Connor, MD UCSD zidovudine, lamivudine, nevirapine Anti-infectives
Aripipazole to Control the Effects of Traumatic Brain Injury(TBI) in Children. Jeffrey L. Blumer, Ph.D.,M.D Cleveland Aripiprazole Psychiatric drugs
Assessment of Linezolid Single Dose Pharmacokinetics in Young Adults, Full-term and pre-term neonates. Gregory L. Kearns, Pharm. D., FCP KansasCity Linezolid Anti-infectives
Bioavailability of a New Oral Niffedipine Suspension John Wilson, M.D. LSUniv Nifedipine Antihypertensives
Biomarkers of Acetaminophen Toxicity in Pediatric Patients. Laura P. James, M.D. Arkansas Acetaminophen Analgesics
Can oral montelukast improve peripheral airway function? Spahn, Joseph NJMed Montelukast Antihistamines
Catechol-O-Methyltransferase pharmocogenetics and Ontogeny as Determinants of Variability in FK463 Pharmacokinetics in Premature Infants. J. Steven Leeder, Pharm.D., Ph.D. KansasCity Catechol-O-Methyltransferase Anti-infectives
Childhood Absence Epilepsy Rx, PK-PD-Pharmacogenetics Link to matching the protocol in clinicaltrial.gov Peter Adamson, M.D., Tracy Glauser, M.D. CHOP ethosuximide, lamotrigine, valproic acid Anticonvulsants
Clonidine for the treatment of neurocognitive sequelae following cancer treatment in children Link to matching the protocol in clinicaltrial.gov Lisa Bomgaars, MD Baylor Clonidine Vasodilators
Codeine and Morphine Pharmacokinetics, Pharmacogentics and Pharmacodynamics in Infants and Children Janice E. Sullivan, M.D. Louisville Codeine/Morphine Analgesics
Comparison of continous subcutaneous, insulin infusion (CSll) vs. multiple daily injection (MDI) therapy in patients with type 1 diabetes Tamborlane Yale Insulin Antidiabetic agents
Comparison of continous subcutaneous, insulin infusion (CSll) vs. multiple daily injection (MDI) therapy in patients with type 1 diabetes William V. Tamborlane, M.D. Yale Insulin Antidiabetic agents
Controlled comparison of pimozide and risperidone in GTS Floyd Sallee Cincinnati Pimozide and Risperidone Psychiatric drugs
CSF Pharmacokinetics of Antimicrobials in Children Link to matching the protocol in clinicaltrial.gov Cassandra Moron, DO Duke Antimicrobial Anti-infectives
CYP2C19 Genotype Status and its Association with Omeprazole PK and PD in Pediatric Subjects. Kearns KansasCity Omeprazole GI drugs
CYP2C19 Genotype Status and its Association with Pantoprazole Pharmacokinetics and Pharmocodynamics in Pediatric subjects Gregory L. Kearns, Pharm.D. KansasCity Pantoprazole GI drugs
CYP2D6 Expression in Children with Type 1 Diabetes John T. Wilson, M.D. LSUniv Insulin Antidiabetic agents
CYP2D6 expression in children with type 1 diabetes: effect of diabetes control and oxidant stress John Wilson, MD LSUniv CYP2D6 Expression in Type I Diabetes Antidiabetic agents
Cytochrome 2D6 enzyme activity and pain management with codeine in patients with sickle cell disease Ewesuedo, Reginald Columbus Codeine Analgesics
Development of Population Pharmacokinetic-Pharmacodynamic (PK-PD) Models of Mycophenolic Acid for Bayesian Dose Individualization in Pediatric Kidney Transplant Patients Link to matching the protocol in clinicaltrial.gov Vinks Cincinnati mycophenolate mofetil Immunosuppressant
Developmental Changes in Regulatory T Cell Number Henry Farrar, M.D. (Site PPRU director T Arkansas N/A Non-therapeutic
Developmental Regulation of CYPs, IA2, 2D6, 3A4 Link to matching the protocol in clinicaltrial.gov J. Steven Leeder, Pharm.D., Ph.D. KansasCity caffeine and dextromethorphan Non-therapeutic
Dose Finding Study of Ibuprofen-Lysinate Intravenous Solution in Premature Neonates-A Placebo controlled Randomized, Double Blinding Parallel Groups Study. Jacob Aranda, M.D. Wayne Ibuprofen L-Lysinate Analgesics
Dose Response Analysis of Inhaled Corticosteroid Systemic Availability Stanley J. Szefler, M.D. NJMed ICS Anti-inflammatory
Dose-ranging, Safety and Efficacy of Cathflo Activase (Alteplase) for the Treatment of Central Catheter Occlusion in Neonates and Infants Link to matching the protocol in clinicaltrial.gov Janice Sullivan, MD Louisville Cathflo Activase (Alteplase) Blood modifiers
Early pharmacotherapy aimed at neuroplasticity in autism Link to matching the protocol in clinicaltrial.gov Diane Chugani, Ph.D Wayne Buspirone Anxiolytic
Early pharmacotherapy aimed at neuroplasticity in autism Link to matching the protocol in clinicaltrial.gov Diane Chugani, Ph.D Wayne Buspirone Anxiolytic
Early Pharmacotherapy Guided by Biomarkers in Autism Diane Chugani, PhD Wayne Buspirone Anxiolytic
Effect of diet on the development of drug metabolism in infants Gregory Kearns, PharmD KansasCity N/A Non-therapeutic
Effect of Genetic Polymorphisms on Toxicity in Acetaminophen Overdose Link to matching the protocol in clinicaltrial.gov Laura James, M.D. Arkansas Acetaminophen Analgesics
Effect of Recombinant Human Growth Hormone (rhGH) Therapy on Hepatic Drug Metabolism in Children with Idiopathic Growth Hormone Deficiency Link to matching the protocol in clinicaltrial.gov Mary Jayne Kennedy, PharmD Louisville rhGH Hormone/Hormone Antagonist
Effective Pain Management in Sickle Cell Disease: CYP2D6 as a Predictor for Failed Home Therapy Sarah L. Alander, M.D. KansasCity n/a Non-therapeutic
Effective treatment of Co-morbid depression and diabetes in youth Reed, Mike, Tamborlane, William Cleveland N/A Antidiabetic agents
Effective treatment of Co-morbid depression and diabetes in youth Reed, Mike, Tamborlane, William Yale N/A Antidiabetic agents
Effects of Diabetes on the PK of Paroxetine William Tamborlane Yale Paroxetine Psychiatric drugs
Effects of Vitamin E on CYP2D6 metabolic drug clearance Wilson, John LSUniv N/A Non-therapeutic
Effects of Vitamin E on CYP2D6 Metabolic Drug Clearance. John Wilson LSUniv N/A Non-therapeutic
Efficacy and Safety Multi-Center Study of Human Growth Hormone-Releasing Factor (GRF 1-44) as a Once-A-Day Dosing in the Long-term Treatment of Hypothalamic Growth Hormone-Deficient Children Connor, James D. UCSD Growth hormone releasing factor (GRF 1-44) Hormones
Efficacy and Safety of Leflunomide Versus Methotrexate in the Treatment of Pediatric Patients with Juvenile Rheumatoid Arthritis Moynes, Barry Baylor Leflunomide vs Methotrexate Antirheumatic agents
Estimation of Riluzole steady-state pharmacokinetics and metabolism in infants with spinal muscular atrophy (SMA). Iannaccone UTSW Riluzole Anticonvulsants
Evaluation of metoclopramide inhibition on CYP2D6 activity in neonates and infants Kristie Palmer, MD/Laura James, MD Arkansas Metoclopramide Anti-emetic
Evaluation of the Efficacy, Safety, Tolerance and Pharmacokinetics of Meropenem for the Treatment of Acute Pulmonary Exacerbations in Patients with Cystic Fibrosis Blumer Cleveland Meropenem Anti-infectives
Evaluation of the multiple-dose PK profile of oral tramadol in hydrochloride in children and adolescents aged 7-16 years (Tram-Peds 007). John Wilson, M.D. LSUniv Tramadol Hydrochloride Analgesics
Evaluation of the pharmacokinetic profile and safety of depakote extended-release tablets in pediatric and adolescent patients (Abbott Laboratories protocol M01-313) Greg Kearns KansasCity Depakote Anticonvulsants
Evaluation of the Pharmacokinetic Profile and Tolerability of ABT-089 Following Administration of a Single Dose in Pediatric Subjects with Attention Deficit Hyperactivity Disorder (ADHD) Gregory Kearns, PharmD, PhD KansasCity ABT-089 Psychiatric drugs
Evaluation of the pharmacokinetics and tolerance of escalating doses of oral pentoxifylline in children with acute kawasaki disease James D. Connor, M.D. UCSD Pentoxifylline Vasodilators
Evaluation of the Pharmacokinetics· and Safety of Intravenous Itraconazole and hydroxypropyl β-cyclodextrin in Pediatric Subjects Ages 6 months to 16 Years Jeffrey Blumer, M.D. Cleveland Itraconazole Anti-infectives
Evaluation of the safety profile of oral tramadol hydrochloride for the treatment of painful conditions in children and adolescents aged seven to sixteen years (TRAMPEDS-008) Peter Adamson, MD CHOP Tramadol Analgesics
Evaluation of Thiopurine Methyltransferase Polymorphisms in the Hispanic Population Link to matching the protocol in clinicaltrial.gov Lisa Bomgaars, MD Baylor N/A Non-therapeutic
EZN-2232-03S: “Screening of Mannose-Binding Lectin (MBL) Status in Pediatric Hematology/Oncology Patients Link to matching the protocol in clinicaltrial.gov Theokolis Zaoutis, MD CHOP N/A Screening Protocol Non-therapeutic
Fluconazole Prophylaxis for the prevention of Candidiasis in Infants <750 Grams Birth Weight Link to matching the protocol in clinicaltrial.gov Daniel K. Benjamin Jr. MD MPH PhD Duke Fluconazole Anti-infectives
Genetic polymorphisms associated with histamine disposition in children with vancomycin associated red man syndrome (RMS) Link to matching the protocol in clinicaltrial.gov Angela Myers, MD/Kathleen Neville, MD, M KansasCity vancomycin Anti-infectives
Glimepiride versus metformin as monotherapy in pediatric subjects with type 2 diabetes mellitus: A single blind comparison study Link to matching the protocol in clinicaltrial.gov Connor, James UCSD Glimepiride (Amaryl) Antidiabetic agents
Histamine Pharmacogenetics in Children with Atopic Dermatitis Link to matching the protocol in clinicaltrial.gov Mary Jayne Kennedy, PharmD Louisville N/A Non-therapeutic
Identification of New Mechanistic Biomarkers of Adverse Responses to Acetaminophen Link to matching the protocol in clinicaltrial.gov Laura P. James, M.D Arkansas Acetaminophen Analgesics
Impact of Pharmacogenetic and Clinical Factors on Warfarin Dosing in Pediatric Patients Lisa Bomgaars, M.D. Baylor Warfarin Blood modifiers
In vivo Functional Assessment of Histamine Pharmacogenomics in Children Link to matching the protocol in clinicaltrial.gov Bridgette Jones, M.D. KansasCity N/A Non-therapeutic
infliximab (Remicade) for Patients with Acute Kawasaki Disease Who fail to become Afebrile After Intravenous Gamma Globulin Therapy Link to matching the protocol in clinicaltrial.gov Jane Burns, MD UCSD Remicade Immunosuppressant
Infliximab plus intravenous immunoglobulin (IVIG) for the primary treatment of patients with acute Kawasaki disease Link to matching the protocol in clinicaltrial.gov Adriana H. Tremoulet, M.D. UCSD Infliximab plus intravenous immunoglobulin (IVIG) Anti-inflammatory
Lansoprazole Disposition in Young Children with Cystic Fibrosis Link to matching the protocol in clinicaltrial.gov Holly Maples, PharmD Arkansas Lansoprazole GI drugs
Lead and its effects on cytochrome P450 Jennifer Lowry, M.D. KansasCity Depakote Non-therapeutic
Levalbuterol and Racemic Albuterol in Pediatric Subjects( Acute care 051-033 protocol) Link to matching the protocol in clinicaltrial.gov Kim Jones, MD LSUniv Levalbuterol Antihypertensives
Levetiracetam To Prevent Post-Traumatic Epilepsy Pavel Klein, MD, JoAnne Natale, MD CNMC Levetiracetam Anticonvulsants
Lidocaine 4% cream (ELA-MAX topical anesthetic cream) for Anesthesia for newborn circumcision Vicki Tutag Lehr, Pharm D Wayne Lidocaine Anesthetics
Linezolid Injection:single dose pharmacokinetic assessment in Pediatric patients following an Intravenous infusion Gregory L. Kearns, Pharm. D., FCP KansasCity Linezolid Anti-infectives
Linezolid IV/PO vs Vancomycin IV for the treatment of Resistant Gram-positive bacterial Infections in Children Jacob Aranda, M.D., Ph.D. Wayne Linezolid M/1260/0082 Anti-infectives
Measurement of Nitrotyrosine Adducts and Cytokines in Acetaminophen Overdose Patients Link to matching the protocol in clinicaltrial.gov Laura James, M.D. Arkansas Acetaminophen Analgesics
Measuring Satisfaction in a Pediatric Clinical Research Center John Wilson, M.D. LSUniv Not applicable Non-therapeutic
Micafungin Lock Therapy to clear fungemia while attempting to preserve central venous catheters Link to matching the protocol in clinicaltrial.gov Christine Salvatore, MD UTSW Micafungin Anti-infectives
Midazolam as a pharmacologic probe for CYP 3A4/3A5 phenotyping Peter C. Adamson M.D. CHOP Midazolam Anesthetics
Morning lantus® (Insulin Glargine [rDNA origin] Injection) vs. intermidiate-acting insulin twice daily as basal insulin in a multiple daily injection regimen with humalog® (Insulin Lispro Injection [rDNA Origin]) in adolescents with type 1 diabetes mellit Link to matching the protocol in clinicaltrial.gov Tamborlane, William Yale Lantus vs insulin Antidiabetic agents
Multicenter open-label pharmacokinetic study of risperidone at steady state in 24 children/adolescent from 5 years of age to less than 18 years of age Dr. Jeffrey Blumer Cleveland Risperidone Psychiatric drugs
Multi-center, double blind, randomized, dose-ranging study, in pediatric patients 5 to < = 16 years of age receiving morphine as standard supplemental pain medication, to evaluate pharmacokinetics, safety, efficacy of Oxy Pediatric Liquid (1 mg/mL) versus Galinkin, Jeffrey CHOP Oxy Pediatric Liquid Analgesics
Multicenter, Open-label, Multiple-Dose Study of the Conversion from Immediate Release Oxycodone (OxyIR ®) to Controlled Release Oxycodone (Oxycontin ®), to Evaluate Pharmacokinetics and to Characterize Safety and Efficacy in Pediatric Patients 6 to <= 16 Galinkin, Jeffrey CHOP Oxycodone Analgesics
Multiple Dose Pharmacokinetic Study of Meropenem in Young Infants (<91 days) with Suspected or Complicated Intra-abdominal Infections Link to matching the protocol in clinicaltrial.gov Daniel K. Benjamin Jr. MD, PhD, MPH Duke Meropenem Anti-infectives
N-carbamylglutamate (Carbaglu): Effect on ureagenesis in N-acetylglutamate deficiency Mendel Tuchman, MD CNMC carbaglu Blood modifiers
Non-Invasive Assessment of Opioid Analgesia in Children with Sickle Cell Disease Link to matching the protocol in clinicaltrial.gov Julia C. Finkel, MD Yewande J. Johnson, CNMC codeine, dextromethorphan, morphine Analgesics
Non-randomized, Open-label, Dose-Escalation Study of Renal and Hemodynamic Effects, Safety, Tolerability and Pharmacokinetics of Continuous Infusion of Fenoldopam in Pediatric Patients Jeff Blumer MD, PhD Cleveland Fenoldapam Vasodilators
Non-randomized, open-label, parallel group single-dose escalation study of the safety, tolerability and pharmacokinetics of intravenously administered BMS-284756 IN pediatric patients Protocol AI464-064 Jeff Blumer Cleveland BMS-284756 Anti-infectives
Non-randomized, Open-Label, Parallel Group, Single-Dose, Dose-Escalation Study of the Pharmacokinetics and Safety of Orally Administered Gatifloxacin in Hospitalized Pediatric Patients James Connor, M.D. UCSD Gatifoxacin Anti-infectives
Novel Predictive Biomarkers in Sickle Cell Disease John T. Wilson, MD LSUniv Pentoxifylline
On open label, two period, sequential study to investigate the safety, tolerability, and preliminary plasma concentration profiles for single doses of MK-0869 in adolescent patients with a history of depression Sallee, Floyd Cincinnati MK-0869 Psychiatric drugs
Open label evaluation of the pharmacokinetic profile on oral tramadol hydrochloride tablets in children and adolescents aged seven to sixteen years. John Wilson, M.D. LSUniv Tramadol Analgesics
Open-Label, Non-Randomized Study Of The Middle Ear Fluid Penetration Of Gatifloxacin In Children Undergoing Tympanostomy Tube Placement Jeffrey Blumer, M.D. Cleveland Gatifloxacin Anti-infectives
Open-Label, Single And Multiple Dose Pharmacokinetic Evaluation Of The Liquid Formulation Of Pleconaril In Pediatric Patients With Acute Enteroviral Meningitis Gregory Kearns, Pharm.D. KansasCity Pleconaril Anti-infectives
Optimizing Antiretroviral Therapy In HIV-Infected Children and Adolescents Link to matching the protocol in clinicaltrial.gov Natella Rakhmanina, MD CNMC antiretroviral agents Anti-infectives
Optimizing Pain Treatment in Pre-Term Neonates Link to matching the protocol in clinicaltrial.gov John van den Anker, MD, PhD CNMC morphine Analgesics
Pediatric population pharmacogenetics John Wilson, MD LSUniv N/A Non-therapeutic
Pharmacodynamica and Pharmacokinetics of Milirinone in Children Mary Lieh Lai, M.D. Wayne Milrinone Vasodilators
Pharmacogenetics of Codeine Biotransformation in Sickle Cell Disease K.A. Neville, MD KansasCity codeine Analgesics
Pharmacogenetics of Inosine Monophosphate Dehydrogenase (IMPDH) in Pediatric Kidney Transplant Patients Link to matching the protocol in clinicaltrial.gov Alexander A. Vinks, Pharm.D., Ph.D., FCP Cincinnati Mycophenolic Acid, MPA Antihistamines
Pharmacogenetics of Mycophenolic Acid in Kidney Transplant Patients Link to matching the protocol in clinicaltrial.gov Sander Vinks Cincinnati Mycophenolic Acid Immunosuppressant
Pharmacogenetics of Risperidone in children with pervasive development disorder (PDD) Link to matching the protocol in clinicaltrial.gov Alexander A. Vinks, Pharm.D., Ph.D. Cincinnati Risperidone Psychiatric drugs
Pharmacokinetic properties of transdermal clonidine in critically ill children. Dimitriades CHOP clonidine Analgesics
Pharmacokinetics And Pharmacodynamics Of Famotidine In Children With Renal Insufficiency Laura James, M.D. Arkansas Famotidine GI drugs
Pharmacokinetics and Pharmacodynamics of Montelukast in Children, Ages 2 Through 5 Years Old, with Status Asthmaticus Unresponsive to Conventional Treatment Link to matching the protocol in clinicaltrial.gov Jeffrey L. Blumer Cleveland Montelukast Anti-inflammatory
Pharmacokinetics and Pharmacodynamics of Montelukast in Children, Ages 6 through 18 years Old with Status Asthmaticus Unresponsive to Conventional Treatment Link to matching the protocol in clinicaltrial.gov Jeffrey L. Blumer Cleveland Montelukast Anti-inflammatory
Pharmacokinetics and Pharmacodynamics of Terbutaline Given as a Continuous Intravenous Infusion in Severe Status Asthmaticus Link to matching the protocol in clinicaltrial.gov Mary Lieh Lai, MD Wayne Terbutaline Other
Pharmacokinetics of a Fluconazole Loading Dose in Infants and Toddlers Link to matching the protocol in clinicaltrial.gov Lauren Piper, MD Duke Fluconazole Anti-infectives
Pharmacokinetics of Anidulafungin in Infants and Toddlers Link to matching the protocol in clinicaltrial.gov Michael Cohen-Wolkowiez, MD Duke Anidulafungin Anti-infectives
Pharmacokinetics of Irbesartan in Hypertensive Children and Adolescents Wells, Thomas G. Arkansas Irbesartan Antihypertensives
Pharmacokinetics of linezolid in children with CF Link to matching the protocol in clinicaltrial.gov ROBERTO P. SANTOS, MD UTSW Linezolid Anti-infectives
Pharmacokinetics of Lopinavir Crushed Versus Whole Tablets Link to matching the protocol in clinicaltrial.gov Brookie Best, Pharm.D. UCSD lopinavir/ritonavir Other
Pharmacokinetics of Nicotine and Cotinine in Pregnant African-American Women and Implications for Pharmalogical Interventions Dana Best, MD, MPH CNMC nicotine
Pharmacokinetics of Oseltamivir During Pregnancy and Lactation Laura Greer, MD UTSW Oseltamivir Anti-infectives
Pharmacokinetics, efficacy and safety of Brevibloc (Esmolol Hydrochloride) for control of supraventricular arrhythmias in children and adolescents age 12-16 years of age- PROTOCOL NO. 20,015-05 Peter Adamson, M.D. CHOP Esmolol Hydrochloride Anti-arrhythmics
Pharmacokinetics, safety, and tolerability of single oral doses (0.1, 0.2, 0.4 and 0.8 mg) of tamsulosin hydrochloride in children with voiding disorders. Philip Walson, MD Cincinnati tamsulosin hydrochloride GU drug
Phase I Pharmacokinetic Study of Imiquimod Cream, 5% in Pediatric Subjects with Molluscum Contagiosum Moise Levy, M.D. (Lisa Bomgaars, M.D.) Baylor Aldara Anti-infectives
Phase I/II Safety, Pharmacokinetic, and Pharmacodynamic Study of Sargramostim (Leukine®) in Pediatric Patients with Active Crohn’s Disease Link to matching the protocol in clinicaltrial.gov Baldassano CHOP Sargramostim Other
Phase II Randomized, Double Blind, Placebo Controlled, Safety and Pharmacokinetic study of a Single Dose of Inositol in Premature Infants Link to matching the protocol in clinicaltrial.gov Pablo Sanchez, MD/ Robert Ward, MD UTSW Inositol
Phase IV, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Intravenous Hectorol (doxercalciferol) in the Treatment of Hyperparathyroidism in Pediatric End-stage Renal Disease (ESRD) Patients Receiving Hemodialyis Russell W. Chesney, M.D. Utenn Hectorol Hormone/Hormone Antagonist
Phase-1 Plasma Pharmacokinetics Study of Lopinavir/Ritonavir in a Once-Daily versus a Twice-Daily Regimen in Pediatrics Chokechai Rongkavilit, MD Wayne Lopinavir/Ritonavir Anti-infectives
Pilot Study to Evaluate the Oral Absorption, Safety, and Tolerability of Nepadutant Administered as Single Oral Doses to Infants with Colic Link to matching the protocol in clinicaltrial.gov Jeffrey Blumer, MD, PhD Cleveland Nepadutant Other
Pilot toxicity/methods validation study of celecoxib in genotype positive children with familiar adenomatous polyposis Link to matching the protocol in clinicaltrial.gov Gilger, Mark Baylor Celecoxib Anti-inflammatory
Placebo Controlled Double Blind Study of Clinical Outcome and Pharmacokinetics of SINGULAIR Therapy in Children with Eosinophilid Duidentitis Craig A. Friesen, M.D. KansasCity SINGULAIR Anti-inflammatory
Plasma Biomarkers to Differentiate Autism Spectrum Disorders Paul Stemmer, PhD Wayne N/A Other
Platelet Aggregation Inhibition in Children on Clopidogrel (Dose-Ranging Pharmacodynamic Assessment of Platelet Aggregation Inhibition with Clopidogrel in Children of Blalock-Taussing Shunt Age Categories) Link to matching the protocol in clinicaltrial.gov Jennifer Li, MD Duke Clopidogrel Blood modifiers
Polymorphisms and prenatal exposure Virginia Delaney-Black (Jack Aranda) Wayne N/A Non-therapeutic
Postprandial Glucose Excursion: Role of Amylin & Glucagon Link to matching the protocol in clinicaltrial.gov Rubina Heptulla, M.D. Baylor Amylin & Glucagon Antidiabetic agents
Randomized double-blind evaluation of the safety, efficacy and tolerability of zolpidem in children who have experienced traumatic brain injury Blumer, Jeffrey Cleveland Zolpidem Sedatives
Randomized double-blind evaluation of the safety, efficacy and tolerability of zolpidem in children with pervasive developmental disorder Blumer, Jeffrey Cleveland Zolpidem Sedatives
Randomized evaluation of the relative bioavailability of zolpidem tablets compared with an extemporaneous liquid preparation Blumer, Jeffrey Cleveland Zolpidem Sedatives
Risperidone pharmacokinetics in children with pervasive development disorder (PDD): Single dose pharmacokinetics and population PK evaluation using a sparse sampling approach Link to matching the protocol in clinicaltrial.gov Vinks, Alexander Cincinnati Risperidone Psychiatric drugs
Role of Novel NPY Receptor Subtype in an Animal Model of Neglect Floyd R. Sallee, M.D., Ph.D. Cincinnati N/A Non-therapeutic
Safety and Single Dose Population Pharmacokinetics and Bioavailability of Methadone and its Enantiomers in Newborns and Young Infants At 29-48 Weeks Post Menstrual Age Link to matching the protocol in clinicaltrial.gov Robert M. Ward, MD Utah Methadone Analgesics
Single and multiple dose pharmacokinetics and safety study of Rabeprazole sodium in 12-16 year old subjects (protocol No. E3810-A001-119) Gregory Kearns, Pharm D.,Ph.D. Arkansas Rabeprazole GI drugs
Single dose pharmacokinetic and pharmacodynamic evaluation of three different zolpidem doses in children ages 6 months to 18 years of age Link to matching the protocol in clinicaltrial.gov Blumer, Jeffrey Cleveland Zolpidem Sedatives
Single-dose Pharmacokinetics of Rifapentine in Children. Gregory Kearns, PharmD, PhD KansasCity Rifapentine Anti-infectives
Single-dose pharmacokinetics of Venofer® (Iron Sucrose Injection) in Adolescentss on hemodialysis or peritoneal dialysis receiving epoetin-PROTOCOL No. 1VEN01016 Link to matching the protocol in clinicaltrial.gov Meyers, Kevin, Adamson, Peter CHOP Venofer Supplement
Study of Blood Pressure Reduction with Fosinopril in Children and Adolescents Tej Mattoo, M.D. Wayne Fosinopril Antihypertensives
Study of the Pharmacokinetics of Sirolimus Administered Orally to Pediatric Subjects with Stable Renal Transplants Douglas Blowey, MD KansasCity Sirolimus Immunosuppressant
Targeted drug delivery using novel polymeric nanostructures (Dendrimers): Asthma & Thrombolysis. Mary Lieh-Lai, M.D. Wayne N/A Non-therapeutic
The effects of cardiopulmonary bypass and modified ultra-filtration on the plasma pharmacokinetics of milrinone in neonates with hypoplastic left heart syndrome Zuppa, Athena, Adamson, Peter CHOP Milrinone Vasodilators
The effects of inhaled fluticasone on inflammatory mediators in neonates at risk for chronic lung disease Kim Adcock, Pharm D LSUniv Fluticasone Antihistamines
The natural course of Trichophyton tonsurans carriage and infection: a molecular and biochemical evaluation Link to matching the protocol in clinicaltrial.gov Susan Abdel-Rahman KansasCity N/A Anti-infectives
The Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Neonates Following Open Heart Surgery Link to matching the protocol in clinicaltrial.gov Felice Su MD CHOP Dexmedetomidine Analgesics
The Pharmacokinetics Of Fosinopril In Children And Adolescents Thomas Wells, M.D. Arkansas Fosinopril Antihypertensives
The pharmacokinetics of Glipizide and Metformin After Administration of a Glipizide/Metformin HCL Combinatin Tablet in Pediatric and Adult Populations. Michael L. Christensen, Pharm. D. Utenn Glipizide and Metformin Antidiabetic agents
The pharmacokinetics of metformin when administered as glucophage in pediatric and adult population William Tamborlane, M.D. Yale Glucophage Antidiabetic agents
The Pharmacokinetics of Voriconazole in Children with Gastrointestinal Graft Versus Host Disease Link to matching the protocol in clinicaltrial.gov Cassandra Moran, DO Duke Voriconazole Anti-infectives
The PK of metformin and glyburide after administration of Glucovance® to patients with type 2 diabetes, ages 10-16. William Tamborlane, M.D. Yale Metformin and Glyubride Antidiabetic agents
The role of ambulatory blood pressure monitoring (ABPM) in interventional trials conducted in children with hypertension: Detection of "white coat" hypertension, comparison of ABPM and casual measurements, and investigation of the placebo effect in childr Link to matching the protocol in clinicaltrial.gov Thomas G. Wells, M.D. Arkansas Placebo Antihypertensives
The role of drug bioactivation and detoxification in the pathogenesis of adverse drug reactions in children Link to matching the protocol in clinicaltrial.gov Leeder, J, Steven KansasCity Carbamazepine and valproic acid Anticonvulsants
The Role of Drug Metabolizing Enzymes in the Pathogenesis Adverse Drug Reactions in Children Link to matching the protocol in clinicaltrial.gov Leeder, J, Steven KansasCity Carbamazepine and valproic acid Anticonvulsants
The Role of Ontogeny on the Development of Phase II Drug Metabolizing Enzymes Kearns, Gregory, O'Behm, Martin KansasCity Not applicable Other
Tolerability and Pharmacokinetics of Inhaled Insulin in Children 6 to 11 Years of Age with Type 1 Diabetes William Tamborlane Yale Inhaled Insulin Antidiabetic agents
Topiramate Pharmacokinetics and Tolerability in Infants with Seizures Harry Chugani, M.D. Wayne Topiramate Anticonvulsants
Ultra-rapid Plasma Clearance of Omeprazole and Pantoprazole in Pediatric Patients Associated with the CYP2C19*17 Genotype Greg Kearns KansasCity Omeprazole/ Pantoprazole Non-therapeutic
Urinary Proteomics in Antimicrobial /Antifungal Treated Newborns Add-on to 10824 Link to matching the protocol in clinicaltrial.gov Kennedy Louisville N/A Non-therapeutic
Use of Lorazepam for the treatment of pediatric status epilepticus Link to matching the protocol in clinicaltrial.gov Chamberlain CNMC Lorazepam Anticonvulsants
Valacyclovir for the treatment of Herpes Zoster in Immunocompromised Children Link to matching the protocol in clinicaltrial.gov Susan Blaney, M.D. Baylor valacyclovir Anti-infectives
Validation of the 13C Acetate Breath Test to Measure Liquid Gastric Emptying in a Pediatric Population. Kearns KansasCity 13C Acetate Non-therapeutic
Vasopressin Antagonism following Cardiopulmonary Bypass Jeff Blumer MD, PhD Cleveland conivaptan hydrochloride Non-therapeutic
Venlafaxine therapy in attention deficit hyperactivity disorder in children Springer, Margaret, Ann LSUniv Venlafaxine Psychiatric drugs
Warfarin Pharmacogenetics in Pediatric Patients Kathleen Neville, MD, MS KansasCity Warfarin Blood modifiers
 
 

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