Clinical trials: Pediatric Safety and Effectiveness
- Condition Pediatric Safety and Effectiveness
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
Major Depressive Disorder
Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder (VLZ-MD-22)
The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone compared with placebo in pediatric outpatients (7-17 years of age) with major depressive disorder.
- Trial name
- VLZ-MD-22 (NCT02372799)
- Testing
- Vilazodone, Fluoxetine
- Where
- 60 sites in United States, Canada
- Volunteers
- 473 people
- Sponsor
- Forest Laboratories
Pseudomonas Aeruginosa Respiratory Tract Infection/Colonization, Cystic Fibrosis
Study of Aztreonam for Inhalation in Children With Cystic Fibrosis and New Infection of the Airways by Pseudomonas Aeruginosa Bacteria
The primary objective of this study is to evaluate the safety and efficacy of a 14-day course versus a 28-day course of aztreonam for inhalation solution (AZLI) in pediatric participants with new onset Pseudomonas aeruginosa…
- Trial name
- ALPINE 2 (NCT03219164)
- Testing
- AZLI
- Where
- 53 sites in United States, Austria and 10 more
- Volunteers
- 149 people
- Sponsor
- Gilead Sciences
Wilson Disease
Study of ALXN1840 Versus Standard of Care in Pediatric Participants With Wilson Disease
This study is being conducted to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics of ALXN1840 versus standard of care in pediatric participants with Wilson disease (WD).
- Trial name
- NCT05047523
- Testing
- ALXN1840, Standard of Care
- Where
- 20 sites in Australia, France and 5 more
- Volunteers
- 40 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Diabetes Mellitus, Type 2
Study to Evaluate Safety and Efficacy of Dapagliflozin and Saxagliptin in Patients With Type 2 Diabetes Mellitus (T2DM) Aged 10 to Below 18 Years Old
The primary objective of this study is to determine if there will be a greater mean reduction from baseline in glycated hemoglobin (HbA1c) achieved after 26 weeks of oral double-blind add-on therapy of dapagliflozin or…
- Trial name
- NCT03199053
- Testing
- Dapagliflozin, Saxagliptin
- Where
- 122 sites in United States, Argentina and 21 more
- Volunteers
- 256 people
- Sponsor
- AstraZeneca
Polyarticular-course Juvenile Idiopathic Arthritis (JIA)
Pediatric Arthritis Study of Certolizumab Pegol
A Multicenter, Open-label Study to Assess the Pharmacokinetics, Safety and Efficacy of Certolizumab Pegol in Children and Adolescents With Moderately to Severely Active Polyarticular-course Juvenile Idiopathic Arthritis (JIA).
- Trial name
- PASCAL (NCT01550003)
- Testing
- Certolizumab Pegol (CZP)
- Where
- 36 sites in United States, Argentina and 5 more
- Volunteers
- 193 people
- Sponsor
- UCB BIOSCIENCES GmbH
Chronic Kidney Disease stage3, Chronic Kidney Disease stage4
Phase 3 Safety and Efficacy Study of CTAP101 Extended-release Capsules in Children With Secondary Hyperparathyroidism
This is a phase 3, multi-center, randomized, double-blind, placebo-controlled study in children with stage 3-4 chronic kidney disease (CKD), secondary hyperparathyroidism (SHPT) and vitamin D insufficiency.
- Conditions
- Chronic Kidney Disease stage3, Chronic Kidney Disease stage4, Vitamin d Deficiency, Secondary Hyperparathyroidism
- Trial name
- NCT05543928
- Testing
- CTAP101
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- OPKO Health, Inc.
Multiple Sclerosis, Relapsing-Remitting
Study to Evaluate the Efficacy and Safety of Dimethyl Fumarate (Tecfidera) and Peginterferon Beta-1a (Plegridy) for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants
The main objective of the study is to evaluate the efficacy of dimethyl fumarate (Tecfidera) and peginterferon beta-1a (Plegridy), both compared with placebo, in pediatric participants with RRMS.
- Trial name
- NCT03870763
- Testing
- Dimethyl Fumarate, Peginterferon Beta-1a
- Where
- 23 sites in United States, Colombia and 11 more
- Volunteers
- 11 people
- Sponsor
- Biogen
Atopic Dermatitis
A Study to Evaluate Long-Term Maintenance Treatment With Once Daily Crisaborole Ointment 2% in Pediatric and Adult Participants With Mild-to-Moderate Atopic Dermatitis
This study will evaluate crisaborole therapy once daily (QD) as a long-term topical maintenance therapy for the reduction of flare in responders to crisaborole twice daily (BID) treatment.
- Trial name
- NCT04040192
- Testing
- Crisaborole 2%, Vehicle
- Where
- 44 sites in United States, Australia and 4 more
- Volunteers
- 620 people
- Sponsor
- Pfizer
Central Nervous System
Pharmacokinetics, Efficacy, and Safety of Perampanel Oral Suspension on Seizure Frequency in Pediatric Subjects Maintained on One to Three Stable Antiepileptic Drugs
This study is designed to evaluate the pharmacokinetics, efficacy, and safety of perampanel oral suspension on seizure frequency in pediatric participants maintained on one to three stable antiepileptic drugs
- Trial name
- NCT01527006
- Testing
- perampanel
- Where
- 23 sites in United States
- Volunteers
- 63 people
- Sponsor
- Eisai Inc.
Iron Deficiency Anemia, Nondialysis-dependent Chronic Kidney Disease
A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia in Pediatric Participants With Nondialysis-Dependent Chronic Kidney Disease
Study evaluating the efficacy and safety of intravenous (IV) ferumoxytol compared with oral iron for the treatment of pediatric participants with chronic kidney disease (CKD).
- Trial name
- NCT01155388
- Testing
- Ferumoxytol, Oral Iron
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- AMAG Pharmaceuticals, Inc.
Psoriasis
An Efficacy, Safety, and Pharmacokinetics Study of Subcutaneously Administered Ustekinumab in the Treatment of Moderate to Severe Chronic Plaque Psoriasis in Pediatric Participants Greater Than or Equal to 6 to Less Than 12 Years of Age
The purpose of this study is to evaluate the efficacy and safety of ustekinumab in pediatric participants aged greater than or equal to (>=) 6 through less than (<) 12 years with moderate to severe chronic plaque psoriasis
- Trial name
- CADMUS Jr (NCT02698475)
- Testing
- Ustekinumab 0.75 mg/kg, Ustekinumab 45 mg, Ustekinumab 90 mg
- Where
- 31 sites in United States, Belgium and 7 more
- Volunteers
- 44 people
- Sponsor
- Janssen Research & Development, LLC
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
Type 2 Diabetes
Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Saxagliptin as Monotherapy in Pediatric Patients With Type 2 Diabetes
The purpose of this study is to evaluate the efficacy, safety, tolerability, of Saxagliptin in pediatric patients with type 2 diabetes.
- Trial name
- NCT01204775
- Testing
- Saxagliptin, Metformin IR, Metformin (Active Rescue)
- Where
- 16 sites in United States, Russia and 2 more
- Volunteers
- 26 people
- Sponsor
- AstraZeneca
Functional Constipation (FC), Chronic Idiopathic Constipation (CIC)
A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation
Functional constipation (FC) is a common healthcare problem in children of all ages, potentially due to genetic predisposition, inadequate fiber and fluid intake, and immobility.
- Trial name
- NCT05652205
- Testing
- Linaclotide
- Where
- 48 sites in United States, Bulgaria and 2 more
- Volunteers
- 123 people
- Sponsor
- AbbVie
Pediatric Growth Hormone Deficiency
Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children
This is an open-label, randomized, multicenter, efficacy and safety study of weekly MOD-4023 compared to daily Genotropin therapy in pre-pubertal children with growth hormone deficiency.
- Trial name
- NCT02968004
- Testing
- MOD-4023, Somatropin
- Where
- 81 sites in United States, Argentina and 18 more
- Volunteers
- 224 people
- Sponsor
- OPKO Health, Inc.
Pain, Fever
Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients
Intravenous acetaminophen (IVAPAP) is safe in repeated dose, multi-day clinical use when administered at a daily dose of 40 to 75 mg/kg body weight
- Trial name
- NCT00598702
- Testing
- IV Acetaminophen
- Where
- 14 sites in United States
- Volunteers
- 100 people
- Sponsor
- Mallinckrodt
Epilepsies, Partial
Safety and Efficacy of Gabapen for Pediatric (Regulatory Post Marketing Commitment Plan)
This investigation aims to understand the following issues in pediatric patients, as well as to assess the need of a special investigation and a post-marketing clinical study: The frequency of treatment related adverse events.
- Trial name
- NCT01441401
- Testing
- gabapentin
- Volunteers
- 82 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Sanfilippo Syndrome, Mucopolysaccharidosis (MPS)
An Extension Study to Determine Safety and Efficacy for Pediatric Patients With MPS Type IIIA Disease Who Participated in Study HGT-SAN-093.
This extension study will allow participants to continue receiving treatment with HGT-1410 and to initiate treatment in patients who received no-treatment in Study HGT-SAN-093, and will evaluate the long-term safety and efficacy…
- Trial name
- NCT02350816
- Testing
- HGT-1410
- Where
- 8 sites in United States, France and 5 more
- Volunteers
- 17 people
- Sponsor
- Shire
Attention Deficit Hyperactivity Disorder (ADHD)
Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 1)
The purpose of this study is to demonstrate the efficacy, safety, and tolerability of SPN-810 in the treatment of Impulsive Aggression (IA) in subjects with Attention-Deficit/Hyperactivity Disorder (ADHD) in conjunction with…
- Trial name
- NCT02618408
- Testing
- SPN-810 (18 mg), SPN-810 (36 mg)
- Where
- 28 sites in United States
- Volunteers
- 333 people
- Sponsor
- Supernus Pharmaceuticals, Inc.
Ulcerative Colitis
A Study of the Safety and Efficacy of Infliximab(REMICADE ) in Pediatric Patients With Moderately to SeverelyActive Ulcerative Colitis
The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade) in children with moderately to severely active ulcerative colitis.
- Trial name
- NCT00336492
- Testing
- infliximab
- Where
- 27 sites in United States, Belgium and 3 more
- Volunteers
- 60 people
- Sponsor
- Centocor, Inc.