Clinical trials: Pediatric Safety and Effectiveness
Chemotherapy-induced Nausea and Vomiting
Efficacy and Safety Study of Fosaprepitant (MK-0517) Plus Ondansetron Versus Ondansetron Alone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Participants (MK-0517-044)
The purpose of this study is to evaluate the efficacy and safety of fosaprepitant (MK-0517) plus ondansetron versus ondansetron alone for the prevention of chemotherapy-induced nausea and vomiting (CINV) in pediatric participants…
- Trial name
- NCT02519842
- Testing
- Fosaprepitant, Ondansetron, Dexamethasone
- Volunteers
- 75 people
- Sponsor
- Merck Sharp & Dohme LLC
RPS19 Deficient Diamond-Blackfan Anemia
Assessing the Safety, Tolerability, and Efficacy of APR-2020 in Pediatric and Adolescent Subjects With RPS19 Deficient Diamond-Blackfan Anemia
Brief summary The goal of this clinical trial is to learn if APR-2020 is safe and can help treat Diamond-Blackfan Anemia (DBA) in adolescents and children.
- Trial name
- NCT07476183
- Testing
- APR-2020
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- Apriligen, Inc.
Relapsed Solid Tumor, Refractory Solid Tumor
REGN2810 in Pediatric Patients With Relapsed, Refractory Solid, or Central Nervous System (CNS) Tumors and Safety and Efficacy of REGN2810 in Combination With Radiotherapy in Pediatric Patients With Newly Diagnosed or Recurrent Glioma
Phase 1: To confirm the safety and anticipated recommended phase 2 dose (RP2D) of REGN2810 (cemiplimab) for children with recurrent or refractory solid or Central Nervous System (CNS) tumors To characterize the pharmacokinetics…
- Conditions
- Relapsed Solid Tumor, Refractory Solid Tumor, Relapsed Central Nervous System Tumor, Refractory Central Nervous System Tumor
- Trial name
- NCT03690869
- Testing
- cemiplimab (monotherapy), cemiplimab (maintenance), Conventional or hypofractionated
- Where
- 20 sites in United States
- Volunteers
- 57 people
- Sponsor
- Regeneron Pharmaceuticals
Thrombocytopenia in Pediatric Subjects With Immune Idiopathic Thrombocytopenic Purpura ITP
A Study Evaluating the Safety and Efficacy of Long-term Dosing of Romiplostim in Thrombocytopenic Pediatric Patients With Immune (Idiopathic) Thrombocytopenia Purpura
This is an extension study designed to assess the safety and durability of platelet count increases with romiplostim treatment of thrombocytopenic patients with immune (Idiopathic) thrombocytopenia purpura.
- Trial name
- NCT01071954
- Testing
- Romiplostim
- Where
- 31 sites in United States, Australia and 2 more
- Volunteers
- 66 people
- Sponsor
- Amgen
Pain
Study of ALGRX 3268 for Needlestick Pain in Children
Minor needlestick procedures often cause significant pain and distress in children, yet interventions to reduce pain are used infrequently.
- Trial name
- NCT00132405
- Testing
- ALGRX 3268
- Where
- United States
- Volunteers
- 260 people
- Sponsor
- AlgoRx Pharmaceuticals
Chronic Pain
A Study to Assess the Safety and Effectiveness of Durogesic (Fentanyl Transdermal Patch) in the Treatment of Children With Chronic Pain Requiring Long-term Narcotic Pain Relief Therapy
The purpose of this study is to assess the effectiveness and safety of Durogesic® (a transdermal patch delivering the narcotic pain-reliever fentanyl) in the treatment of children with chronic pain requiring long-term narcotic…
- Trial name
- NCT00271453
- Testing
- Durogesic® (fentanyl transdermal drug delivery system)
- Volunteers
- 41 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Central Precocious Puberty
A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial)
The primary objective of this study is to evaluate the efficacy of Debio 4326 in suppressing serum luteinizing hormone (LH) to prepubertal levels 52 weeks after the first Debio 4326 injection in pediatric participants with…
- Trial name
- NCT06129539
- Testing
- Debio 4326
- Where
- 17 sites in United States, Argentina and 3 more
- Volunteers
- 56 people
- Sponsor
- Debiopharm International SA
Diabetes Mellitus, Insulin-Dependent
Comparison of the Ability of Glulisine With Lispro to Control Type 1 Diabetes Mellitus in Children and Adolescents
The purpose of this study is to determine if insulin glulisine (Apidra) is as safe and effective a rapid acting insulin as insulin lispro (Humalog) in children and adolescents with type 1 diabetes mellitus.
- Trial name
- NCT00115570
- Testing
- Insulin glulisine, insulin lispro, insulin glargine
- Where
- United States
- Volunteers
- 572 people
- Sponsor
- Sanofi
Transthoracic Echocardiography, Suspected or Known Structural or Functional Cardiac Abnormality
Study to Determine Safety and Dosage of OPTISON in Pediatric Participants
Study to determine the safety and appropriate dosage of OPTISON in pediatric participants since OPTISON has been tested in adult participants only during the clinical development
- Trial name
- NCT03740997
- Testing
- Optison
- Where
- 8 sites in United States
- Volunteers
- 39 people
- Sponsor
- GE Healthcare
Partial Onset Seizures
A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.
This study is designed to evaluate the effectiveness of 2 doses of pregabalin to reduce seizure frequency as an add on therapy in pediatric subjects 1 month to <4 years of age with refractory partial onset seizures.
- Trial name
- NCT02072824
- Testing
- Pregabalin Dose Level 1, Pregabalin Dose Level 2
- Where
- 72 sites in United States, Belarus and 21 more
- Volunteers
- 175 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
164 Boys for Hypospadias Surgery Under General Anesthesia With Caudal Block
Caudal Dexmedetomidine Analgesia in Pediatrics .
Dexmedetomidine (DEXM) is a highly selective α2-adrenoceptor agonist that has been used increasingly in pediatric anesthesia. This prospective double blinded randomized comparative study is designed to evaluate the analgesic…
- Trial name
- NCT03791879
- Testing
- Caudal dexamedatomidine analgesia
- Where
- Egypt
- Volunteers
- 164 people
- Sponsor
- Mansoura University
Central Nervous System Diseases, Central Nervous System Neoplasms
Evaluation of Safety and Efficacy of ProHance in Pediatric Patients <2yrs
Safety and Efficacy Study in pediatric subjects <2 years of age who have undergone Brain or Spine MRI pre and post 0.1 mmol/kg ProHance administration. Imaging conditions will represent those in routine clinical practice.
- Trial name
- NCT03750188
- Testing
- ProHance
- Where
- United States
- Volunteers
- 125 people
- Sponsor
- Bracco Diagnostics, Inc
Attention Deficit Hyperactivity Disorder, Attention-Deficit / Hyperactivity Disorder
A Phase 3 Study of Viloxazine ER Capsules in Korean Children and Adolescents With ADHD
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter bridging clinical trial designed to evaluate the efficacy and safety of viloxazine extended-release capsules (AK-D101) compared with placebo in Korean…
- Conditions
- Attention Deficit Hyperactivity Disorder, Attention-Deficit / Hyperactivity Disorder, ADHD
- Trial name
- AK-D101_BS (NCT07678827)
- Testing
- AK-D101
- Where
- South Korea
- Volunteers
- 156 people
- Sponsor
- Alvogen Korea
Atopic Dermatitis
A Study to Investigate Safety and Efficacy of Tapinarof Cream, 1% in Participants Ages 3 Months to < 24 Months With Atopic Dermatitis
The purpose of this global Phase 3 clinical study is to investigate the safety and efficacy of tapinarof cream, 1% in participants ages 3 months to 23 months (inclusive) with atopic dermatitis.
- Trial name
- Adoring (NCT07265479)
- Testing
- Tapinarof cream, 1%, Vehicle Cream
- Where
- 46 sites in United States, Canada
- Volunteers
- 187 people
- Sponsor
- Organon and Co
Child Obesity, Bowel Preparation
Efficacy, Safety and Tolerability of Different Bowel Preparation Before Colonoscopy in Children Over 2 Years Old
Electronic colonoscopy plays an important role in the diagnosis and follow-up of intestinal diseases in children.
- Trial name
- NCT04525560
- Testing
- PEG-ELS-S, PEG-ELS-L
- Where
- China
- Volunteers
- 315 people
- Sponsor
- Children's Hospital of Fudan University
Schizophrenia, Schizo-Affective Disorder
Determining Efficacy and Safety of BXCL501 in Agitation Associated With Pediatric Schizophrenia and Bipolar Disorder
This is a study of the efficacy and safety of BXCL501 in children and adolescents with acute agitation and either bipolar disorder or schizophrenia.
- Conditions
- Schizophrenia, Schizo-Affective Disorder, Schizophreniform; Schizophrenic, Bipolar Disorder I
- Trial name
- NCT05025605
- Testing
- BXCL501 80 Micrograms, BXCL501 120 Micrograms, BXCL501 60 Micrograms
- Where
- 5 sites in United States
- Volunteers
- 140 people
- Sponsor
- BioXcel Therapeutics Inc
Pediatric Growth Hormone Deficiency
Versartis Trial in Children to Assess Long-Acting Growth Hormone
This is a Phase 1b/2a study of VRS-317 (long-acting growth hormone) in pediatric patients with growth hormone deficiency. During Phase 1b, pediatric patients each will receive a single subcutaneous injection of VRS-317.
- Trial name
- VERTICAL (NCT01718041)
- Testing
- Experimental: VRS-317
- Where
- 23 sites in United States
- Volunteers
- 64 people
- Sponsor
- Versartis Inc.
Pediatric, Symptomatic Obstructive Hypertrophic Cardiomyopathy
A Study to Evaluate the Effect of Aficamten in Pediatric Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM).
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of aficamten in a pediatric population with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
- Trial name
- CEDAR-HCM (NCT06412666)
- Testing
- Aficamten
- Where
- 36 sites in United States, Canada and 4 more
- Volunteers
- 65 people
- Sponsor
- Cytokinetics
Tinea Capitis
Terbinafine Compared to Griseofulvin in Children With Tinea Capitis
Tinea capitis is a dermatophyte infection of the scalp hair follicles, which occurs primarily in children. Hair loss, hair breakage, scaling, plus various degrees of erythema, pustules and pruritus are the primary clinical signs…
- Trial name
- NCT00117754
- Testing
- Terbinafine hydrochloride
- Where
- United States
- Volunteers
- 720 people
- Sponsor
- Novartis
Relapsed/Refractory Acute Myeloid Leukemia
Safety and Efficacy of NK520 to Treat Pediatric Relapsed/Refractory Acute Myeloid Leukemia
This study will evaluate the safety and efficacy of NK520 in the treatment of pediatric relapsed/refractory acute myeloid leukemia. NK520 will be administered by intravenous injection.
- Trial name
- NCT06541405
- Testing
- NK520
- Where
- China
- Volunteers
- 2 people
- Sponsor
- Base Therapeutics (Shanghai) Co., Ltd.
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