NCT02699385

A Study to Evaluate the Safety and Efficacy of Domperidone in Pediatric Participants With Nausea and Vomiting Due to Acute Gastroenteritis

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Janssen-Cilag International NV · Industry
• Sex: All
• Age: 6 Months – 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Gastroenteritis

Interventions

Type	Name	Description
OTHER	Oral Rehydration Therapy	Each participants will initiate ORT in the physician's office on Day 1.
DRUG	Domperidone	Each participants will receive Domperidone 0.25 milligram per killogram (mg/kg) of body weight of oral suspension thrice daily for up to 7 days.
DRUG	Placebo	Each participants will receive placebo oral suspension thrice daily for up to 7 days.

Timeline

• Start date: 2015-12-07
• Primary completion: 2017-08-03
• Completion: 2017-08-03
• First posted: 2016-03-04
• Last updated: 2019-03-20

Locations

29 sites across 6 countries: Austria, Belgium, Russia, South Africa, Spain, United Kingdom