R033812GTS3001: Domperidone v Placebo in children 6 months to 12 years
Research type
Research Study
Full 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
IRAS ID
202759
Contact name
Rajeev Gupta
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2015-002923-24
Duration of Study in the UK
2 years, 2 months, 30 days
Research summary
The main objective of this study is to show that domperidone liquid medicine plus Oral Rehydration Therapy (ORT) is more effective than placebo (a liquid with no active medicine in it) plus ORT at reducing the symptoms of vomiting associated with acute gastroenteritis (AG) within 48 hours of the first successful treatment administration in children, 6 months to 12 years old, with AG and mild-to-moderate dehydration. Domperidone has been approved since 1978 in more than 100 countries for the relief of the symptoms of nausea and vomiting, sense of fullness in upper abdomen, upper-abdominal discomfort, and regurgitation of gastric contents in adults, and for the relief of the symptoms of nausea and vomiting in children.
480 paediatric participants 6 months to 12 years of age will be randomly assigned in this study with 240 participants planned per treatment group (domperidone or placebo).
Participants will receive treatment for 2-7 (maximum) days and will be followed for safety evaluations for about 15 days. The amount of time participants take the study drug may vary depending on how they respond to treatment.
Participants will attend 3 clinic visits, the initial visit, the next day (24 hours later) and then on the last day of the study.
The study is divided into 3 parts:
• Screening: the doctor will check participants are eligible to participate.
• Treatment: Treatment will be between 2 and 7 days.
• Follow-up: The clinic will telephone participants 3 times during the study. These telephone calls will be done on days 3, 4 and 8. They will be asked questions regarding health and vomiting, nausea (in children 4 years of age and older) and diarrhoea episodes. If participants’ symptoms worsen during the study period at any time another clinic visit may be scheduled.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
16/YH/0154
Date of REC Opinion
23 Aug 2016
REC opinion
Further Information Favourable Opinion