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

PHASE3TerminatedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

December 7, 2015

Primary Completion Date

August 3, 2017

Study Completion Date

August 3, 2017

Conditions
Gastroenteritis
Interventions
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.

Trial Locations (29)

Unknown

Gröbming

Salzburg

Vienna

Brussels

Herbeumont

Massemen

Moorsel

Novosibirsk

Saint Petersburg

Cape Town

Durban

Krugersdorp

Middelburg

Newtown

Pietermaritzburg

Pretoria

Burriana

Gandia

Valencia

Vic

Barnsley

Ipswich

Maidstone

Middlesbrough

Nottingham

Oldham

Royal Tunbridge Wells

Staffordshire

Sutton in Ashfield

Sponsors
All Listed Sponsors
lead

Janssen-Cilag International NV

INDUSTRY

NCT02699385 - A Study to Evaluate the Safety and Efficacy of Domperidone in Pediatric Participants With Nausea and Vomiting Due to Acute Gastroenteritis | Biotech Hunter | Biotech Hunter