Clinical trials: Pediatric
Nausea and Vomiting, Postoperative
Study of Intravenous Amisulpride for Prophylaxis of Post-operative Nausea and Vomiting (PONV) in Pediatric Patients
Randomized, double-blind, pediatric trial of amisulpride for prophylaxis of post operative nausea and vomiting
- Trial name
- NCT05546359
- Testing
- Amisulpride Injection, Dexamethasone
- Where
- 14 sites in United States, Canada and 2 more
- Volunteers
- 453 people
- Sponsor
- Acacia Pharma Ltd
Liver Surgery, Liver Dysfunction
Octaplas Pediatric Plasma Replacement Trial
The purpose of this study is to investigate the safety, tolerability and efficacy of octaplas in pediatric patients who require replacement of multiple coagulation factors.
- Conditions
- Liver Surgery, Liver Dysfunction, Coagulopathy, Cardiac Surgery
- Trial name
- NCT02050841
- Testing
- octaplas
- Where
- 4 sites in United States
- Volunteers
- 50 people
- Sponsor
- Octapharma
Scorpion Sting Envenomation
Open Label Study of Alacramyn® in Pediatric Patients With Scorpion Sting Envenomation
There is no FDA approved therapy for the treatment of scorpion envenomation in the United States. Centruroides scorpion envenomation produces a pattern of neurotoxicity with a spectrum of severity ranging from trivial to life…
- Trial name
- NCT01599923
- Testing
- Antivenin Centruroides (scorpion) equine immune F(ab')2
- Where
- Mexico
- Volunteers
- 29 people
- Sponsor
- Instituto Bioclon S.A. de C.V.
Tourette Syndrome, Tourette Syndrome in Adolescence
A Study to Explore the Effect of Sepranolone in Tourette Syndrome
The study was an open-label, randomized, multicenter, parallel, Phase 2a study in adolescents and adult patients with Tourette syndrome that aimed to explore the efficacy of Sepranolone as a treatment for Tourette syndrome, by…
- Trial name
- NCT05434546
- Testing
- Sepranolone
- Where
- 2 sites in Denmark
- Volunteers
- 26 people
- Sponsor
- Asarina Pharma
Sphingomyelin Lipidosis
Safety, Tolerability, PK, and Efficacy Evaluation of Repeat Ascending Doses of Olipudase Alfa in Pediatric Patients <18 Years of Age With Acid Sphingomyelinase Deficiency
Primary Objective: To evaluate the safety and tolerability of olipudase alfa administered intravenously in pediatric participants every 2 weeks for 64 weeks.
- Trial name
- ASCEND-Peds (NCT02292654)
- Testing
- Olipudase alfa
- Where
- 6 sites in United States, Brazil and 4 more
- Volunteers
- 20 people
- Sponsor
- Genzyme, a Sanofi Company
Steroid Refractory GVHD
Evaluation of EFficacy and SaFEty of Leukotac (Inolimomab) in Pediatric Patients With SR-aGvHD
A Phase 3, Multicenter, open label, study to Evaluate the EFficacy and SaFEty of Leukotac® (inolimomab) in pediatric patients with steroid resistant acute Graft versus Host Disease (SR-aGvHD)
- Trial name
- EiFFEL (NCT04289103)
- Testing
- Inolimomab (Leukotac)
- Volunteers
- 65 people
- Sponsor
- ElsaLys Biotech
Botulism
BT-010 Registry for the Evaluation of Safety and Clinical Outcomes in Patients Treated With Botulinum Antitoxin
The purpose of the Registry was to evaluate patient safety following Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine) (BAT®) administration in adult and pediatric patients with a confirmed or suspected exposure to…
- Trial name
- NCT02055183
- Testing
- BAT
- Volunteers
- 162 people
- Sponsor
- Emergent BioSolutions
Epilepsy
Open-label Long-term Study of Adjunctive Brivaracetam in Pediatric Subjects With Epilepsy
This study will evaluate the safety and tolerability of brivaracetam in pediatric subjects with epilepsy.
- Trial name
- NCT01364597
- Testing
- Brivaracetam (BRV)
- Where
- 56 sites in United States, Belgium and 10 more
- Volunteers
- 257 people
- Sponsor
- UCB Pharma SA
Pain
Safety and Pharmacokinetic Study of Oral Morphine Sulfate in Pediatric Subjects
The purpose of this study is to evaluate the tolerability and safety of oral morphine sulfate in the treatment of postoperative pain in different pediatric age groups following multiple-dose administration.
- Trial name
- NCT01322360
- Testing
- Morphine Sulfate
- Where
- 11 sites in United States
- Volunteers
- 50 people
- Sponsor
- Roxane Laboratories
Acute Myeloid Leukemia, Diffuse Large B Cell Lymphoma (DLBCL)
GRACE: A Phase 1/2a Study of VTRU200 in Relapsed/Refractory AML, High-risk MDS, DLBCL Post CART Failure and Advanced Solid Tumors
About this study This is the first study of VTRU200 in people. The main purpose of this study is to find a safe dose of VTRU200 and learn how the medicine behaves in the body.
- Conditions
- Acute Myeloid Leukemia, Diffuse Large B Cell Lymphoma (DLBCL), High Risk Myelodysplastic Syndrome, Solid Tumor Malignancies
- Trial name
- NCT07749976
- Testing
- VTRU200
- Volunteers
- 108 people
- Sponsor
- Vitruviae
Anal Fissure
Pharmacokinetic,Safety and Exploratory Efficacy of RECTIV® in Adolescents With Chronic Anal Fissure
RECTIV® is an ointment containing 0.4% nitroglycerin (NTG) for the treatment of moderate to severe pain associated with chronic anal fissure approved in June 2011 by the US Food and Drug Administration (FDA) for adults.
- Trial name
- NCT01920074
- Testing
- Nitroglycerin Ointment 0.4%
- Where
- 6 sites in United States
- Sponsor
- Forest Laboratories
Fibromyalgia
Adolescent Fibromyalgia Study
This study will compare pregabalin with placebo over a 15 week period in adolescents with fibromyalgia aged 12-17 years to evaluate the safety and efficacy of pregabalin.
- Trial name
- NCT01020474
- Testing
- pregabalin (Lyrica)
- Where
- 36 sites in United States, Czechia and 2 more
- Volunteers
- 107 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
HIV Infections
A Study of 1592U89 in HIV-Infected Children
The purpose of this study is to see if it is safe to give 1592U89 to children (aged 6 months until 14th birthday) with advanced HIV infection who have few treatment options available.
- Trial name
- NCT00002197
- Testing
- Abacavir sulfate
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Glaxo Wellcome
Hemophilia B
Evaluation of a Recombinant Factor IX Product, APVO101, in Previously-Treated Pediatric Patients With Hemophilia B
Phase 3/4, single arm, open-label study to evaluate PK, safety, and efficacy of APVO101 prophylaxis in severe or moderately severe hemophilia B subjects < 12 years of age.
- Trial name
- NCT03855280
- Testing
- APVO101
- Where
- 11 sites in Brazil, Georgia and 4 more
- Volunteers
- 21 people
- Sponsor
- Medexus Pharma, Inc.
Clostridium Difficile Infection
Comparison of Cadazolid Versus Vancomycin in Children With Clostridium Difficile-associated Diarrhea (CDAD)
Cadazolid has demonstrated activity against a bacteria named Clostridium difficile in animal studies. The results of a first study conducted in adult patients have suggested efficacy of the new antibiotic, cadazolid, in the…
- Trial name
- NCT03105479
- Testing
- Cadazolid, Vancomycin capsule, Vancomycin solution
- Where
- 20 sites in United States, Belgium and 7 more
- Volunteers
- 1 people
- Sponsor
- Actelion
Attention Deficit Hyperactivity Disorder
Safety and Efficacy of MTS Versus Concerta in Pediatric Patients (Aged 6-12 Years) With ADHD
Study designed to evaluate the safety and efficacy of MTS compared to placebo with reference to CONCERTA® in pediatric subjects diagnosed with ADHD.
- Trial name
- NCT00444574
- Testing
- Methylphenidate Transdermal System, Concerta
- Volunteers
- 282 people
- Sponsor
- Noven Therapeutics
Facioscapulohumeral Muscular Dystrophy (FSHD)
Evaluate Safety and Biological Activity of ATYR1940 in Participants With Early Onset Facioscapulohumeral Muscular Dystrophy
The purpose of this study is to assess the safety and biological activity of ATYR1940 in participants with early onset FSHD.
- Trial name
- FSHD (NCT02603562)
- Testing
- ATYR1940
- Where
- 7 sites in United States, France and 1 more
- Volunteers
- 8 people
- Sponsor
- aTyr Pharma, Inc.
Healthy
Relative Bioavailability of Three Oral Formulations Candidates of Rilpivirine for Potential Pediatric Use Compared to Oral Tablet
The purpose of this study is to compare the rate and extent of absorption of rilpivirine in healthy adult participants following: 1) administration of a single dose of two different oral dispersible tablet formulation candidates…
- Trial name
- NCT02561936
- Testing
- Rilpivirine Oral Tablet, Rilpivirine formulation G007, Rilpivirine formulation G009-01
- Where
- Belgium
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Janssen Sciences Ireland UC
Leukodystrophy, Globoid Cell
Study of Safety, Tolerability and Efficacy of PBKR03 in Pediatric Subjects With Early Infantile Krabbe Disease
PBKR03 is a gene therapy for Krabbe Disease (Globoid cell leukodystrophy) intended to deliver a functional copy of the GALC gene to the brain and peripheral tissues.
- Trial name
- GALax-C (NCT04771416)
- Testing
- PBKR03
- Where
- 9 sites in United States, Brazil and 4 more
- Volunteers
- 24 people
- Sponsor
- Gemma Biotherapeutics
Recurrent Pericarditis
REgiStry Of the NAtural History of recurreNt periCarditis in pEdiatric and Adult Patients
The registry will focus on furthering the understanding of the natural history of recurrent pericarditis (RP), as well as document RP-related clinical, health-related quality of life (HRQoL), and economic burden and will assist…
- Trial name
- RESONANCE (NCT04687358)
- Where
- 29 sites in United States
- Volunteers
- 500 people
- Sponsor
- Kiniksa Pharmaceuticals International, plc
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