Clinical trials: Pediatric Safety and Effectiveness
Schizophrenia, Affective Disorders
Safety And Efficacy Study Of Ziprasidone In Pediatric Psychotic Illness
The purpose of this research is to determine if Ziprasidone is safe and effective for use in children and adolescents with a psychotic illness, and to determine of Ziprasidone treatment leads to weight changes in children.
- Conditions
- Schizophrenia, Affective Disorders, Psychotic Disorder, Psychotic Mood Disorder
- Trial name
- NCT00199940
- Testing
- Ziprasidone
- Volunteers
- 20 people
- Sponsor
- Medical College of Wisconsin
Anemia of Chronic Kidney Disease
Study to Evaluate the Safety and Efficacy of Oral Vadadustat in Pediatric Participants With Anemia of Chronic Kidney Disease
This study will assess the safety and efficacy of once daily dosing of vadadustat for the treatment of pediatric participants with anemia of Chronic Kidney Disease (CKD) after conversion from an Erythropoiesis Stimulating Agent…
- Trial name
- CONVERSION (NCT05082571)
- Testing
- vadadustat
- Where
- United States
- Sponsor
- Akebia Therapeutics
Failure to Thrive
Somatropin Treatment in Patients With SHOX Deficiency and Turner Syndrome
This clinical trial will compare the mean first year height velocity of somatropin-treated prepubertal patients with SHOX deficiency with the height velocity of a control group of untreated prepubertal patients with SHOX…
- Trial name
- NCT00190658
- Testing
- Somatropin (rDNA origin) for injection
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Eli Lilly and Company
Otitis Media, Infections, Respiratory Tract
Study to Evaluate the Safety and Clinical Efficacy of Augmentin® Extra Strength-600 in Children With Acute Otitis Media in India
Augmentin (ES)-600 is a high-dose amoxicillin/clavulanic acid 14:1 formulation that allows administration at 90/6.4 milligrams (mg)/kilograms (kg)/day in two divided doses.
- Conditions
- Otitis Media, Infections, Respiratory Tract, Respiratory Tract Infections
- Trial name
- NCT04600752
- Testing
- Augmentin (ES)-600
- Where
- 13 sites in India
- Volunteers
- 310 people
- Sponsor
- GlaxoSmithKline
Spinal Muscular Atrophy (SMA)
SPX-01 Gene Therapy in Pediatric Patients With Spinal Muscular Atrophy Type 1 (RISE)
The goal of this clinical trial is to learn about the safety, and tolerability of giving an experimental gene therapy called SPX-01 to an infant with spinal muscular atrophy (SMA) type 1.
- Trial name
- NCT07903376
- Testing
- SPX-01
- Where
- Iran
- Volunteers
- 1 people
- Sponsor
- Exir Gene Pharmed
Allergic Conjunctivitis
A Study to Evaluate the Efficacy and Safety of Fel d 1 Monoclonal Antibodies in Adult and Pediatric Participants With Allergic Conjunctivitis Due to Cat Allergy
This study is researching two experimental medicines, freneslerbart and mevonlerbart. Freneslerbart and mevonlerbart can be given alone or together. When given together, the medicine is called "REGN-2Cat".
- Trial name
- NCT07675811
- Testing
- REGN-2Cat, Freneslerbart, Mevonlerbart
- Where
- United States
- Volunteers
- 570 people
- Sponsor
- Regeneron Pharmaceuticals
Anxiety
Pharmacogenetically-guided Escitalopram Treatment for Pediatric Anxiety: Aiming to Improve Safety and Efficacy (PrEcISE)
This double-blind, 12-week study will consist include132 anxious youth who are randomized (1:1) to standard or pharmacogenetically-guided escitalopram dosing.
- Trial name
- PrEcISE (NCT04623099)
- Testing
- Escitalopram
- Where
- United States
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- University of Cincinnati
Chronic Hepatitis C Infection
A Study to Evaluate Treatment of Hepatitis C Virus Infection in Pediatric Subjects
This was a Phase 2/3, open-label, multicenter study to evaluate the pharmacokinetics (PK), efficacy, and safety of ombitasvir/paritaprevir/ritonavir (OBV/PTV/RTV) with or without dasabuvir (DSV) and with or without ribavirin…
- Trial name
- ZIRCON (NCT02486406)
- Testing
- Ombitasvir/paritaprevir/ritonavir, Dasabuvir, Ribavirin
- Where
- 21 sites in United States, Belgium and 3 more
- Volunteers
- 64 people
- Sponsor
- AbbVie
Colonoscopy Preparation
Macrogole Versus Sodium Picosulfate in Bowel Cleansing for Colonoscopy in Pediatric Inflammatory Bowel Disease
Children hospitalized at the Department of Pediatric Gastroenterology and Nutrition at the Medical University of Warsaw with suspected or confirmed inflammatory bowel disease (IBD) will be invited to participate in the study.
- Trial name
- NCT07786363
- Testing
- polyethylene glycol (PEG 4000) (Forlax ®), Citrafleet®
- Where
- Poland
- Volunteers
- 125 people
- Sponsor
- Medical University of Warsaw
Myopia
Evaluate the Efficacy and Safety of CTO0308 in Pediatric Patients With Myopia
This study was to evaluate the superiority of the myopia progression control effect in the treatment group compared with the control group, evaluated by the change in spherical equivalent (SE) after 12 months of administration of…
- Trial name
- NCT07790640
- Testing
- CTO0308
- Where
- South Korea
- Volunteers
- 351 people
- Sponsor
- Taejoon Pharmaceutical Co., Ltd.
Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia
The Effectiveness of the Neutropenic Diet in Pediatric Oncology Patients
The purpose of this study is to determine if FDA approved food safety guidelines are equivalent to a low bacterial diet (the neutropenic diet) with respect to the acquisition of infections during neutropenia in a sample of…
- Conditions
- Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Non-Hodgkins Lymphoma, Sarcoma
- Trial name
- NCT00726934
- Testing
- Food Safety Guidelines, Neutropenic Diet
- Where
- 6 sites in United States
- Volunteers
- 149 people
- Sponsor
- Indiana University
Plastic Bronchitis, Protein-Losing Enteropathies
Inhaled Tissue Plasminogen Activator for Acute Plastic Bronchitis
Plastic bronchitis (PB) is a rare, most often pediatric disease characterized by the formation of obstructive airway casts primarily composed of fibrin.
- Conditions
- Plastic Bronchitis, Protein-Losing Enteropathies, Healthy
- Trial name
- PLATyPuS (NCT02315898)
- Testing
- Treatment-inhaled tPA
- Where
- 6 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of Michigan
Tamsulosin, Extracorporeal Shock Wave Lithotripsy
The Efficacy and Safety of Medical Expulsive Therapy After Extracorporeal Shock Wave Lithotripsy (ESWL) in Pediatric Urolithiasis
The aim of this study is to evaluate the clinical efficacy and safety of MET after ESWL in pediatric urolithiasis.
- Conditions
- Tamsulosin, Extracorporeal Shock Wave Lithotripsy, Stone, Kidney, Stone, Urinary
- Trial name
- NCT05759767
- Testing
- Tamsulosin
- Where
- Egypt
- Volunteers
- 120 people
- Sponsor
- Mansoura University
Lupus Erythematosus, Systemic
Atherosclerosis Prevention in Pediatric Lupus Erythematosus (APPLE)
The purpose of this study is: 1. To assess the efficacy of a lipid-lowering agent (atorvastatin) on the development of atherosclerosis that predisposes children with SLE to cardiovascular events in adulthood. 2.
- Trial name
- NCT00065806
- Testing
- Atorvastatin
- Where
- United States
- Volunteers
- 221 people
- Sponsor
- Laura Schanberg
Sedation
Safety And Efficacy Of Dexmedetomidine Sedation In Intubated Mechanically Ventilated Infants With Respiratory Failure
Dexmedetomidine is a highly selective α2-agonist with hypnotic, analgesic, and anxiolytic properties. Despite off-label administration, dexmedetomidine has found a niche in critically ill mechanically ventilated neonates and…
- Trial name
- DEXinPICU (NCT02996058)
- Testing
- Dexmedetomidine 0.35µg/kg /h, Dexmedetomidine 0.5µg/kg /h
- Where
- Egypt
- Volunteers
- 40 people
- Sponsor
- Assiut University
Narcolepsy, Sleep Apnea, Obstructive
PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
The primary objective of the study is to evaluate the safety and tolerability of treatment with PROVIGIL in children and adolescents with excessive sleepiness (ES) associated with narcolepsy or OSAHS (obstructive sleep…
- Trial name
- NCT00107848
- Testing
- Modafinil
- Where
- 61 sites in United States, Canada
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- Cephalon
Insomnia
Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Daridorexant in Subjects Aged 10 to < 18 Years With Insomnia Disorder
This study assesses the efficacy, safety, and pharmacokinetics of multiple-dose oral administration of daridorexant in pediatric subjects aged 10 to < 18 years with insomnia disorder.
- Trial name
- NCT05423717
- Testing
- Daridorexant 10 mg, Daridorexant 25 mg, Daridorexant 50 mg
- Where
- 35 sites in United States, Bulgaria and 4 more
- Volunteers
- 166 people
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Acute Hematogenous Osteomyelitis
Safety and Efficacy Study of Daptomycin Compared to Active Comparator in Pediatric Participants With Acute Hematogenous Osteomyelitis (AHO) (MK-3009-006)
The purpose of the study is to determine whether daptomycin is effective and safe in the treatment of pediatric participants with AHO when compared to vancomycin (or equivalent) or nafcillin (or β-lactam equivalent).
- Trial name
- NCT01922011
- Testing
- Daptomycin, Vancomycin (or equivalent), Nafcillin (or equivalent)
- Volunteers
- 149 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Skin Wound, Burns
StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects
Autografting is a surgical procedure to transplant healthy skin (donor skin) from another part of the participant's own body (donor site) to the burned part. Autografting is the usual treatment for DPT burns.
- Conditions
- Skin Wound, Burns, Trauma-related Wound
- Trial name
- StrataSTEPS (NCT05517902)
- Testing
- StrataGraft
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Stratatech, a Mallinckrodt Company
Pediatric Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ALL), Ph+ Mixed Phenotype Acute Leukemia (MPAL)
A Study of Ponatinib With Chemotherapy in Children, Teenagers, and Adults With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
This study is about an anticancer drug called ponatinib which is a tyrosine kinase inhibitor given with chemotherapy to children, teenagers, and young adults up to 21 years of age with Philadelphia Chromosome-Positive Acute…
- Conditions
- Pediatric Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ALL), Ph+ Mixed Phenotype Acute Leukemia (MPAL), Philadelphia Chromosome-Like ALL (Ph-like ALL)
- Trial name
- NCT04501614
- Testing
- Ponatinib, Chemotherapy Agents
- Where
- 64 sites in United States, Argentina and 13 more
- Volunteers
- 11 people
- Sponsor
- Takeda
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