Gastroenteritis Clinical Trial
Official title:
A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group, Prospective Study to Evaluate the Safety and Efficacy of Domperidone in 6-month-old to 12-year-old Pediatric Subjects With Nausea and Vomiting Due to Acute Gastroenteritis
The purpose of this study is to demonstrate that domperidone suspension plus oral rehydration therapy (ORT) is more effective than placebo plus ORT at reducing the symptoms of vomiting associated with acute gastroenteritis (AG) within the first 48 hours of treatment administration in pediatric participants with AG and mild-to-moderate dehydration.
This is a randomized (study medication assigned to participants by chance), double-blind (neither the researchers nor the participants know what treatment the participant is receiving), parallel-group, placebo-controlled, multicenter (when more than one hospital or medical school team work on a medical research study) study. The study consists of 3 Phases: Screening Phase (-2 to 0 hours prior to baseline on Day 1), Double-blind treatment Phase (up to 7 Days) and follow-up Phase (7 Days). The duration of participation in the study for each participant is at most 15 Days. Efficacy and safety of domperidone will be evaluated. Participants' safety will be monitored throughout the study. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01168401 -
Bivalent Norovirus Vaccine Study
|
Phase 1 | |
| Completed |
NCT02541695 -
Characterization of Resistance Against Live-attenuated Diarrhoeagenic E. Coli
|
N/A | |
| Completed |
NCT02473887 -
Flavored Intravenous Ondansetron Administered Orally for the Treatment of Persistent Vomiting
|
Phase 1 | |
| Completed |
NCT01911143 -
A Retrospective, Blinded Validation of a Host-response Based Diagnostics
|
N/A | |
| Not yet recruiting |
NCT01671137 -
Probiotic for the Prevention of Functional Disorders in Childhood
|
N/A | |
| Completed |
NCT01917461 -
Observational, Prospective Clinical Study to Evaluate Biomarkers as Indicators of Acute Bacterial or Viral Infections
|
N/A | |
| Withdrawn |
NCT00691275 -
Efficacy Study of IV Fluids Only vs Ondansetron to Treat Dehydration
|
N/A | |
| Recruiting |
NCT06025695 -
Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix Porcine Circovirus (PCV)-Free Liquid Compared to Rotarix Liquid Given in 2-doses in Healthy Chinese Infants Starting at Age 6-16 Weeks
|
Phase 3 | |
| Completed |
NCT04463082 -
Non-invasive Assessment of the Current State of Hydration in Children by Ultrasound
|
N/A | |
| Completed |
NCT02497417 -
A Multi-Site Clinical Evaluation of the ARIES Clostridium Difficile Assay in Symptomatic Patients
|
N/A | |
| Active, not recruiting |
NCT03000296 -
Autologous Unselected Hematopoietic Stem Cell Transplantation for Refractory Crohn's Disease
|
N/A | |
| Completed |
NCT01236066 -
Impact of Rotavirus Vaccination on Hospitalisations for Rotavirus Gastroenteritis in Children Aged <5 Years in Australia
|
N/A | |
| Completed |
NCT01225042 -
The Effect of Probiotics on E. Coli Gastroenteritis
|
N/A | |
| Recruiting |
NCT00987519 -
Viral Respiratory and Gastrointestinal Infections in Children Under 6 Years of Age
|
N/A | |
| Terminated |
NCT01357174 -
ROTATEQ™ Post-Marketing Surveillance in the Philippines
|
N/A | |
| Completed |
NCT01033799 -
Effect of the Consumption of a Fermented Milk on Common Infections in Shift-workers
|
N/A | |
| Recruiting |
NCT01363726 -
Surveillance of Rotavirus Gastroenteritis in Children <5 Years
|
N/A | |
| Completed |
NCT00130832 -
Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants (V260-014)(COMPLETED)
|
Phase 3 | |
| Terminated |
NCT02568189 -
Utility of Ultrasound Assessment of the Inferior Vena Cava in Patients With Sepsis and Dehydration
|
N/A | |
| Terminated |
NCT02165813 -
Oral Nitazoxanide in Acute Gastroenteritis in Australian Indigenous Children
|
Phase 2/Phase 3 |