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

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002923-24-GB

Enrollment

480

Registered

2016-03-08

Start date

Unknown

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nausea and Vomiting Due to Acute Gastroenteritis MedDRA version: 18.1 Level: LLT Classification code 10066762 Term: Acute gastroenteritis System Organ Class: 100000004862

Interventions

Trade Name: Motilium Pharmaceutical Form: Oral suspension INN or Proposed INN: DOMPERIDONE CAS Number: 99497-03-7 Concentration unit: mg

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - The participant presents with at least 3 episodes of nonbilious, 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 Are the trial subjects under 18? yes Number of subjects for this age range: 480 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to demonstrate that domperidone suspension (1 mg/mL) plus ORT is more effective than placebo plus ORT at reducing the symptoms of vomiting associated with AG within the first 48 hours of treatment administration in pediatric subjects, 6 months to 12 years old, with AG and mild-to-moderate dehydration. Overall safety will be assessed. ;Secondary Objective: The secondary objectives are to compare the treatment groups with regard to improvements in the frequency of nausea episodes (in children aged 4 years or older), hydration status, weight change, proportion of subjects who visit an emergency department or require hospital treatment, within 0 to 24-hour, >24- to 48-hour, and >48-hour to 7-day periods after the first treatment administration.;Primary end point(s): Percentage of Participants With No Vomiting Episode Within the First 48 Hours of the First Treatment Administration.;Timepoint(s) of evaluation of this end point: 48 Hours	—

Measure

Time frame

Main Objective: The primary objective of this study is to demonstrate that domperidone suspension (1 mg/mL) plus ORT is more effective than placebo plus ORT at reducing the symptoms of vomiting associated with AG within the first 48 hours of treatment administration in pediatric subjects, 6 months to 12 years old, with AG and mild-to-moderate dehydration. Overall safety will be assessed. ;Secondary Objective: The secondary objectives are to compare the treatment groups with regard to improvements in the frequency of nausea episodes (in children aged 4 years or older), hydration status, weight change, proportion of subjects who visit an emergency department or require hospital treatment, within 0 to 24-hour, >24- to 48-hour, and >48-hour to 7-day periods after the first treatment administration.;Primary end point(s): Percentage of Participants With No Vomiting Episode Within the First 48 Hours of the First Treatment Administration.;Timepoint(s) of evaluation of this end point: 48 Hours

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: a) 48 Hours b) - l) Day 7 m) - n) Baseline and Day 2 o) Day 7 ; Secondary end point(s): a) 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 b) 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 c) 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 d) 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 e) 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 f) 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 g) Percentage of Participants 4 Years of Age or Older Who Have No Episode of Nausea Within the 7 Day Treatment Period After the First Treatment Administration h) Percentage of Participants Taking a Rescue Medication Within the 7 Day Treatment Period i) Percentage of Participants Stopping Study Medication Early Due to Vomiting-Free for 24 Hours Within the 7 Day Treatment Period j) Time to Last Study Medication Within the 7 Day Treatment Period k) Percentage of Participants Referred to an Emergency Room/Hospital for Treatment Within the	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: a) 48 Hours b) - l) Day 7 m) - n) Baseline and Day 2 o) Day 7 ; Secondary end point(s): a) 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 b) 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 c) 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 d) 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 e) 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 f) 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 g) Percentage of Participants 4 Years of Age or Older Who Have No Episode of Nausea Within the 7 Day Treatment Period After the First Treatment Administration h) Percentage of Participants Taking a Rescue Medication Within the 7 Day Treatment Period i) Percentage of Participants Stopping Study Medication Early Due to Vomiting-Free for 24 Hours Within the 7 Day Treatment Period j) Time to Last Study Medication Within the 7 Day Treatment Period k) Percentage of Participants Referred to an Emergency Room/Hospital for Treatment Within the

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Countries

Austria, Belgium, Italy, Portugal, Russian Federation, South Africa, Spain, United Kingdom

Contacts

Public ContactClinical Registry Group

Janssen Cilag International NV

ClinicalTrialsEU@its.jnj.com+3171524 21 66

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026