Study Stopped
Study prematurely terminated upon recommendation of IDMC due to lack of efficacy.
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
3 other identifiers
interventional
10
6 countries
29
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2015
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 7, 2015
CompletedFirst Submitted
Initial submission to the registry
February 15, 2016
CompletedFirst Posted
Study publicly available on registry
March 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 3, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 3, 2017
CompletedMarch 20, 2019
March 1, 2019
1.7 years
February 15, 2016
March 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With No Vomiting Episode Within the First 48 Hours of the First Treatment Administration
The vomiting episodes will be recorded for each participants in the eDiary.
48 Hours
Secondary Outcomes (15)
Percentage of Participants 4 Years of Age or Older Who Have No Episode of Nausea Within the First 48 Hours of the First Treatment Administration
48 Hours
Number of Vomiting Episodes for Participants Within the 0 to 24 Hour, Greater Than (>) 24 to 48 Hour, and >48 Hour to 7 Day Periods After the First Treatment Administration
Up to Day 7
Number of Episodes of Nausea for Participants 4 Years of Age or Older Within the 0 to 24 Hour, >24 to 48 Hour, and >48 Hour to 7 Day Periods After the First Treatment Administration
Up to Day 7
Percentage of Participants who Have No Episode of Vomiting Within the 0 to 24 Hour, >24 to 48 Hour, and >48 Hour to 7 Day Periods After the First Treatment Administration
Up to Day 7
Percentage of Participants 4 Years of Age or Older Who Have No Episode of Nausea Within the 0 to 24 Hour, >24 to 48 Hour, and >48 Hour to 7 Day Periods After the First Treatment Administration
Up to Day 7
- +10 more secondary outcomes
Study Arms (2)
Oral Rehydration Therapy (ORT) + Domperidone
EXPERIMENTALEach participants will initiate ORT in the physician's office and domperidone 0.25 milligram per kilogram (mg/kg) of body weight of oral suspension thrice daily for up to 7 days.
Oral Rehydration Therapy + Placebo
EXPERIMENTALEach participants will initiate ORT in the physician's office and placebo oral suspension thrice daily for up to 7 days.
Interventions
Each participants will initiate ORT in the physician's office on Day 1.
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.
Each participants will receive placebo oral suspension thrice daily for up to 7 days.
Eligibility Criteria
You may qualify if:
- The participant presents with at least 3 episodes of non-bilious, non-bloody vomiting within the 24 hours prior to visiting the physician's office. The participant has at least 2 signs and symptoms other than vomiting consistent with acute gastroenteritis (AG) (example, fever, nausea, diarrhea, abdominal pain, bloating, or discomfort) within 3 hours prior to visiting the physician's office
- The participant has mild-to-moderate dehydration
- The participant had at least 1 episode of non-bloody diarrhea within the 24 hours prior to the visiting the physician's office
You may not qualify if:
- The participant has severe dehydration or severe malnutrition
- The participant who has vomiting and clinical symptoms for longer than 72 hours prior to the baseline physician's office visit
- The participant needs intravenous (IV) fluid replacement
- The participant has chronic severe diarrhea, a previous history of Helicobacter pylori infection or received treatment for H. pylori-induced gastritis, active peptic ulcer, celiac disease, Crohn's disease, ulcerative colitis, eosinophilic esophagitis, malabsorption, short bowel syndrome, post-viral gastroparesis, cyclic vomiting syndrome, or previous gastrointestinal surgery
- The participant has upper respiratory symptoms such as cough, congestion, otitis media or pharyngitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Unknown Facility
Gröbming, Austria
Unknown Facility
Salzburg, Austria
Unknown Facility
Vienna, Austria
Unknown Facility
Brussels, Belgium
Unknown Facility
Herbeumont, Belgium
Unknown Facility
Massemen, Belgium
Unknown Facility
Moorsel, Belgium
Unknown Facility
Novosibirsk, Russia
Unknown Facility
Saint Petersburg, Russia
Unknown Facility
Cape Town, South Africa
Unknown Facility
Durban, South Africa
Unknown Facility
Krugersdorp, South Africa
Unknown Facility
Middelburg, South Africa
Unknown Facility
Newtown, South Africa
Unknown Facility
Pietermaritzburg, South Africa
Unknown Facility
Pretoria, South Africa
Unknown Facility
Burriana, Spain
Unknown Facility
Gandia, Spain
Unknown Facility
Valencia, Spain
Unknown Facility
Vic, Spain
Unknown Facility
Barnsley, United Kingdom
Unknown Facility
Ipswich, United Kingdom
Unknown Facility
Maidstone, United Kingdom
Unknown Facility
Middlesbrough, United Kingdom
Unknown Facility
Nottingham, United Kingdom
Unknown Facility
Oldham, United Kingdom
Unknown Facility
Royal Tunbridge Wells, United Kingdom
Unknown Facility
Staffordshire, United Kingdom
Unknown Facility
Sutton in Ashfield, United Kingdom
Related Publications (1)
Leitz G, Hu P, Appiani C, Li Q, Mitha E, Garces-Sanchez M, Gupta R. Safety and Efficacy of Low-dose Domperidone for Treating Nausea and Vomiting Due to Acute Gastroenteritis in Children. J Pediatr Gastroenterol Nutr. 2019 Oct;69(4):425-430. doi: 10.1097/MPG.0000000000002409.
PMID: 31181017DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen-Cilag International NV Clinical Trial
Janssen-Cilag International NV
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2016
First Posted
March 4, 2016
Study Start
December 7, 2015
Primary Completion
August 3, 2017
Study Completion
August 3, 2017
Last Updated
March 20, 2019
Record last verified: 2019-03