Clinical trials: Pediatric Safety and Effectiveness
Allergic Rhinitis Due to Dermatophagoides Farinae, Allergic Rhinitis Due to Dermatophagoides Pteronyssinus
House Dust Mite Allergy Trial In Children
A research study of how house dust mite tablets work compared to placebo in children aged between 5 and 11 years and who have allergy to house dust mites (MATIC)
- Conditions
- Allergic Rhinitis Due to Dermatophagoides Farinae, Allergic Rhinitis Due to Dermatophagoides Pteronyssinus, Allergic Rhinitis Due to House Dust Mite
- Trial name
- MATIC (NCT04145219)
- Testing
- Sublingual allergy immunotherapy tablet
- Where
- 113 sites in United States, Bulgaria and 9 more
- Volunteers
- 1,460 people
- Sponsor
- ALK-Abelló A/S
Diabetes Mellitus
Observational Study to Evaluate the Effectiveness and Safety of the Dexcom G4 Continuous Glucose Monitoring System in Pediatrics
The purpose of this study is to evaluate the effectiveness and safety of the Dexcom G4 System when used as an adjuvant to blood glucose testing over a 7-day period in people 2 to 17 years-old with diabetes mellitus.
- Trial name
- NCT02363907
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- DexCom, Inc.
Chronic Immune Thrombocytopenia
Study to Evaluate the Efficacy and Safety of PANZYGA in Pediatric Patients With Chronic Immune Thrombocytopenia (ITP)
This is a prospective, open-label, single-arm, multicenter, Phase 4 study evaluating the efficacy and safety of PANZYGA in pediatric patients with chronic ITP.
- Trial name
- NCT03866798
- Testing
- Panzyga
- Where
- 8 sites in United States
- Volunteers
- 6 people
- Sponsor
- Octapharma
Asthma
Montelukast Back to School Asthma Study (0476-340)
This study, in children with chronic asthma, evaluates the number of days of worsening asthma during 8 weeks of treatment with montelukast after treatment is started for the first day of school.
- Trial name
- NCT00461032
- Testing
- montelukast
- Volunteers
- 1,162 people
- Sponsor
- Organon and Co
Reactive Airways Disease (RAD)
Study of Levalbuterol and Racemic Albuterol in Pediatric Subjects With Reactive Airways Disease (RAD)
The purpose of this study is to compare the efficacy of two dose levels of levalbuterol compared with one dose level of racemic albuterol in pediatric subjects aged birth to 48 months old.
- Trial name
- NCT00685126
- Testing
- Levalbuterol HCl Inhalation Solution, Albuterol HCl Inhalation Solution
- Where
- 34 sites in United States, Canada
- Volunteers
- 117 people
- Sponsor
- Sumitomo Pharma America, Inc.
HIV Infections
The Safety and Effectiveness of Two Forms of Saquinavir Combined With Other Anti-HIV Drugs in HIV-Infected Infants and Children
To determine the pharmacokinetic properties, tolerance and safety of 2 formulations of saquinavir, given in combination with 2 nucleoside antiretroviral drugs (part 1) or in combination with nelfinavir and nucleoside…
- Trial name
- NCT00002380
- Testing
- Nelfinavir mesylate, Saquinavir
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Hoffmann-La Roche
Familial Hypercholesterolemia
PLUTO: Pediatric Lipid-redUction Trial of rOsuvastatin
The primary objective of this study is to determine the efficacy of once-daily rosuvastatin in reducing LDL-C in children and adolescents aged 10-17 years with HeFH from baseline (Day 0) to the end of the 12-week double-blind…
- Trial name
- NCT00355615
- Testing
- Rosuvastatin
- Where
- 20 sites in United States, Canada and 3 more
- Volunteers
- 173 people
- Sponsor
- AstraZeneca
Proliferative Vitreoretinopathy
Methotrexate For The Prevention and Treatment of Proliferative Vitreoretinopathy in Pediatric Patients
Rhegmatogenous retinal detachment (RRD) is a sight-threatening condition. Children with RRD usually present late with clinical features of longstanding RRD, specifically a serious condition named: proliferative vitreoretinopathy…
- Trial name
- SIGHT (NCT04830878)
- Testing
- Methotrexate
- Where
- United States
- Sponsor
- Stanford University
Autoimmune Diseases, SLE - Systemic Lupus Erythematosus
RD06-05 Universal CD19/BCMA CAR-T for Refractory Pediatric Autoimmune Diseases
This is a single-arm, open-label, phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-05, a universal CD19/BCMA dual-targeting chimeric antigen receptor T-cell…
- Conditions
- Autoimmune Diseases, SLE - Systemic Lupus Erythematosus, SSc-Systemic Sclerosis, IIM- Idiopathic Inflammatory Myopathies
- Trial name
- NCT07674147
- Testing
- RD06-05 CART Cell Infusion
- Where
- 2 sites in China
- Volunteers
- 30 people
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine
Type 2 Diabetes Mellitus
A Pooled Analysis of the Safety and Efficacy of MK-0431A and MK-0431A XR in Pediatric Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Therapy (Alone or in Combination With Insulin) (MK-0431A-170/MK-0431A-289)
The purpose of this study is to assess the effect of the addition of sitagliptin (administered as MK-0431A or MK-0431A XR) relative to the addition of placebo on glycated hemoglobin (A1C), and the safety and tolerability of the…
- Trial name
- NCT01760447
- Testing
- Sitagliptin plus metformin, Metformin, Sitagliptin plus metformin XR
- Volunteers
- 223 people
- Sponsor
- Merck Sharp & Dohme LLC
Complicated Urinary Tract Infection, Pyelonephritis
MK-7625A Versus Meropenem in Pediatric Participants With Complicated Urinary Tract Infection (cUTI) (MK-7625A-034)
This study aims to evaluate the safety and tolerability of MK-7625A (ceftolozane/tazobactam) compared with that of meropenem in pediatric participants with cUTI, including pyelonephritis.
- Trial name
- NCT03230838
- Testing
- Ceftolozane/Tazobactam, Meropenem
- Where
- 52 sites in United States, Greece and 8 more
- Volunteers
- 134 people
- Sponsor
- Merck Sharp & Dohme LLC
Growth Hormone Deficiency, Pediatric, Endocrine System Diseases
A Long-Term Trial Investigating Safety and Efficacy of TransCon hGH in Children With Growth Hormone Deficiency Who Have Completed a Prior TransCon hGH Clinical Trial
A multicenter, phase 3, long-term extension trial of TransCon hGH administered once-weekly in children with growth hormone deficiency (GHD) who previously participated in a phase 3 TransCon hGH trial.
- Conditions
- Growth Hormone Deficiency, Pediatric, Endocrine System Diseases, Hormone Deficiency, Pituitary Diseases
- Trial name
- enliGHten (NCT03344458)
- Testing
- TransCon hGH
- Where
- 42 sites in United States, Armenia and 9 more
- Volunteers
- 298 people
- Sponsor
- Ascendis Pharma A/S
Constipation
Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation
The primary purpose of this study is to evaluate the safety and efficacy of lubiprostone in a pediatric population with constipation, including the pharmacokinetics of lubiprostone, in a subset of patients.
- Trial name
- NCT00452335
- Testing
- Lubiprostone
- Where
- 19 sites in United States
- Volunteers
- 127 people
- Sponsor
- Sucampo Pharma Americas, LLC
Migraine
Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine
This study will evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to <12 years) and adolescents (12 to <18 years) with chronic migraine.
- Trial name
- OASIS(CM) (NCT03832998)
- Testing
- Erenumab Dose 1, Erenumab Dose 2, Erenumab Dose 3
- Where
- 101 sites in United States, Belgium and 11 more
- Volunteers
- 284 people
- Sponsor
- Amgen
Myopia
Microdosed Atropine 0.1% and 0.01% Ophthalmic Solutions for Reduction of Pediatric Myopia Progression
This study evaluates the progression of myopia in participants using microdosed atropine 0.01%, atropine 0.1%, or placebo ophthalmic solution. Eligible subjects will administer study medication daily in each eye for 48 months.
- Trial name
- NCT03942419
- Testing
- Atropine 0.1% Ophthalmic Solution, Atropine 0.01% Ophthalmic Solution
- Where
- 18 sites in United States
- Volunteers
- 438 people
- Sponsor
- Eyenovia Inc.
Colitis, Ulcerative
A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis
The purpose of this study is to evaluate the effectiveness and safety of ozanimod (RPC1063) in achieving and maintaining clinical remission.
- Trial name
- NCT05076175
- Testing
- Ozanimod
- Where
- 91 sites in United States, Australia and 11 more
- Volunteers
- 120 people
- Sponsor
- Bristol-Myers Squibb
Epilepsies, Partial
A Phase III Open-Label Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures
Examine the efficacy, safety and pharmacokinetics of gabapentin as adjunctive therapy in Japanese pediatric patients with partial seizures
- Trial name
- NCT00603473
- Testing
- gabapentin
- Where
- 26 sites in Japan
- Volunteers
- 92 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Primary Immune Deficiency Disease
Safety and Efficacy Study of Flebogamma 5% DIF IGIV in Pediatric Subjects
This is a multi-center, open-label study to assess the efficacy and safety of Flebogamma 5% DIF in the pediatric population.
- Trial name
- NCT00634569
- Testing
- Flebogamma 5% DIF
- Where
- 7 sites in United States
- Volunteers
- 24 people
- Sponsor
- Instituto Grifols, S.A.
Duchenne Muscular Dystrophy
A Long-term Follow-up Study of Participants Who Received Delandistrogene Moxeparvovec (SRP-9001) in a Previous Clinical Study
The purpose of this study is to provide a single clinical study with a uniform approach to monitoring long-term safety and efficacy in participants who received delandistrogene moxeparvovec in a previous clinical study.
- Trial name
- EXPEDITION (NCT05967351)
- Testing
- delandistrogene moxeparvovec
- Where
- 38 sites in United States, Belgium and 7 more
- Volunteers
- 400 people
- Sponsor
- Sarepta Therapeutics, Inc.
Nakajo-Nishimura Syndrome, Chronic Atypical Neutrophilic Dermatosis With Lipodystrophy and Elevated Temperature Syndrome
A Study of Baricitinib (LY3009104) in Adult and Pediatric Japanese Participants With NNS/CANDLE, SAVI, and AGS
The main purpose of this study is to evaluate the efficacy and safety of baricitinib in adult and pediatric Japanese participants with Nakajo-Nishimura Syndrome/chronic atypical neutrophilic dermatosis with lipodystrophy and…
- Conditions
- Nakajo-Nishimura Syndrome, Chronic Atypical Neutrophilic Dermatosis With Lipodystrophy and Elevated Temperature Syndrome, STING-Associated Vasculopathy With Onset in Infancy, Aicardi Goutieres Syndrome
- Trial name
- NCT04517253
- Testing
- Baricitinib
- Where
- 5 sites in Japan
- Volunteers
- 10 people
- Sponsor
- Eli Lilly and Company
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