|
|
| Protocol Title | Study PI | Lead Site | Drug Name | Therapeutic 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.
|
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
|
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
|
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
|
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-
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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)
|
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
|
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
|
Ali Bader, MD
|
CNMC
|
Rabeprazole
|
GI drugs
|
|
A Pharmacokinetic Study of Actinomycin-D in Children with Cancer
|
Peter Adamson, MD, Jeffrey Skolnik, MD
|
CHOP
|
Actinomycin-D
|
Anti-infectives
|
|
A Pharmacokinetic Study of Dexmedetomidine in Infants
|
Athena Zuppa, MD
|
CHOP
|
Dexmedetomine
|
Sedatives
|
|
A pharmacokinetic study of valacyclovir in pediatric oncology patients
|
Lisa Bomgaars, MD
|
Baylor
|
Valacyclovir
|
Anti-infectives
|
|
A pharmacokinetic study to determine the oral bioavailability of methotrexate in patients with inflammatory bowel disease
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
Benjamin
|
Duke
|
micafungin
|
Anti-infectives
|
|
A Phase I Escalation Study of Sodium Phenylbutyrate in Pediatric subjects with type I Spinal Muscular Atrophy (SMA)
|
Susan Iannaccone
|
UTSW
|
Sodium Phenylbutyrate
|
|
|
A Phase I Escalation Study of Sodium Phenylbutyrate in Pediatric subjects with type II/III Spinal Muscular Atrophy (SMA)
|
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
|
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
|
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
|
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.
|
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
|
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
|
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
|
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
|
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.
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
Greg Kearns, PharmD, PhD
|
KansasCity
|
Ropinirole
|
Dopamine receptors agonists
|
|
An Open-Label Pilot Study of Pentoxifylline in Steroid-Naive Duchenne Muscular Dystrophy
|
Diana Escolar, MD
|
CNMC
|
Pentoxifylline
|
Vasodilators
|
|
an open-label study of the single-dose pharmacokinetics of Olmesartan Medoxonil in pediatric patients with hypertension
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
Janice Sullivan, MD
|
Louisville
|
Cathflo Activase (Alteplase)
|
Blood modifiers
|
|
Early pharmacotherapy aimed at neuroplasticity in autism
|
Diane Chugani, Ph.D
|
Wayne
|
Buspirone
|
Anxiolytic
|
|
Early pharmacotherapy aimed at neuroplasticity in autism
|
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
|
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
|
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
|
Lisa Bomgaars, MD
|
Baylor
|
N/A
|
Non-therapeutic
|
|
EZN-2232-03S: “Screening of Mannose-Binding Lectin (MBL) Status in Pediatric Hematology/Oncology Patients
|
Theokolis Zaoutis, MD
|
CHOP
|
N/A Screening Protocol
|
Non-therapeutic
|
|
Fluconazole Prophylaxis for the prevention of Candidiasis in Infants <750 Grams Birth Weight
|
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)
|
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
|
Connor, James
|
UCSD
|
Glimepiride (Amaryl)
|
Antidiabetic agents
|
|
Histamine Pharmacogenetics in Children with Atopic Dermatitis
|
Mary Jayne Kennedy, PharmD
|
Louisville
|
N/A
|
Non-therapeutic
|
|
Identification of New Mechanistic Biomarkers of Adverse Responses to Acetaminophen
|
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
|
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
|
Jane Burns, MD
|
UCSD
|
Remicade
|
Immunosuppressant
|
|
Infliximab plus intravenous immunoglobulin (IVIG) for the primary treatment of patients with acute Kawasaki disease
|
Adriana H. Tremoulet, M.D.
|
UCSD
|
Infliximab plus intravenous immunoglobulin (IVIG)
|
Anti-inflammatory
|
|
Lansoprazole Disposition in Young Children with Cystic Fibrosis
|
Holly Maples, PharmD
|
|