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

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.

Study Overview

• Status: Terminated
• Conditions: Gastroenteritis
• Intervention / Treatment: Other: Oral Rehydration Therapy; Drug: Domperidone; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Gröbming, Austria
  • Salzburg, Austria
  • Vienna, Austria
  • Wien N/A, Austria
• Belgium
  • Brussel, Belgium
  • Brussels, Belgium
  • Herbeumont, Belgium
  • Massemen, Belgium
  • Moorsel, Belgium
• Russian Federation
  • Novosibirsk, Russian Federation
  • St. Petersburg, Russian Federation
  • St.Petersburg, Russian Federation
• South Africa
  • Cape Town, South Africa
  • Durban, South Africa
  • Krugersdorp, South Africa
  • Middelburg, South Africa
  • Newtown, South Africa
  • Pietermaritzburg, South Africa
  • Pretoria, South Africa
• Spain
  • Borriana, Spain
  • Gandia, Spain
  • Valencia, Spain
  • Vic, Spain
• United Kingdom
  • Barnsley, United Kingdom
  • Ipswich, United Kingdom
  • Maidstone, United Kingdom
  • Middlesborough, United Kingdom
  • Nottingham, United Kingdom
  • Oldham, United Kingdom
  • Staffordshire, United Kingdom
  • Sutton In Ashfield, United Kingdom
  • Tunbridge Wells, United Kingdom

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 months to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Rehydration Therapy (ORT) + Domperidone; Each 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.	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.
Experimental: Oral Rehydration Therapy + Placebo; Each participants will initiate ORT in the physician's office and placebo oral suspension thrice daily for up to 7 days.	Other: Oral Rehydration Therapy; Each participants will initiate ORT in the physician's office on Day 1.; Drug: Placebo; Each participants will receive placebo oral suspension thrice daily for up to 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The nausea episodes will be recorded in the eDiary.	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	The vomiting episodes will be recorded for each participants in the eDiary.	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	The nausea episodes will be recorded in the eDiary.	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	The vomiting episodes will be recorded for each participants in the eDiary.	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	The nausea episodes will be recorded in the eDiary.	Up to Day 7
Percentage of Participants Who Have No Episode of Vomiting Within the 7 Day Treatment Period After the First Treatment Administration	The vomiting episodes will be recorded for each participants in the eDiary.	Day 7
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	The nausea episodes will be recorded in the eDiary.	Day 7
Percentage of Participants Taking a Rescue Medication Within the 7 Day Treatment Period	If nausea, vomiting, or diarrhea worsens during the study and the investigator initiates rescue medication, the study medication will be discontinued.	Day 7
Percentage of Participants Stopping Study Medication Early Due to Vomiting-Free for 24 Hours Within the 7 Day Treatment Period	The vomiting episodes will be recorded for each participants in the eDiary.	Day 7
Time to Last Study Medication Within the 7 Day Treatment Period	Time taken to administer last study medication will be observed.	Day 7
Percentage of Participants Referred to an Emergency Room/Hospital for Treatment Within the 7 Day Treatment Period	If nausea, vomiting, or diarrhea worsens during the study and admits the participant to the hospital for IV fluids, the study medication will be discontinued.	Day 7
Time-to-Last Vomiting Within the 7 Day Period After the First Treatment Administration	The vomiting episodes will be recorded for each participants in the eDiary.	Day 7
Change From Baseline in Hydration Score at Day 2	The severity of dehydration will be assessed using the Dehydration Score Assessment. a) Children under 24 months of age with a score range 7 to 10 points have mild dehydration and children with a score range of 11 to 17 points have moderate dehydration (only children under 24 months of age are evaluated for tears). b) Children 24 months of age or older with a score range of 6 to 9 points have mild dehydration and children with a score range of 10 to 15 points have moderate dehydration. and c) Children under 24 months of age with scores of 18 or more and children 24 months of age or older with scores of 16 or more are considered to be severely dehydrated and are excluded from the study.	Baseline and Day 2
Change From Baseline in Weight at Day 2	Weight will be measured to the nearest 100 grams in underwear (no diaper/nappy/training pants).	Baseline and Day 2
Percentage of Participants With Diarrhea Within 0 to 24 Hour, >24 to 48 Hour, >48 Hour to 7 Day, and 0 Hour to 7 Day Periods After the First Successful Treatment Administration	The diarrhea episodes will be recorded for each participant in the eDiary.	Up to Day 7

Collaborators and Investigators

• Sponsor: Janssen-Cilag International NV

Publications and helpful links

General Publications

• 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.

Helpful Links

• 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

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2015
• Primary Completion (Actual): August 3, 2017
• Study Completion (Actual): August 3, 2017

Study Registration Dates

• First Submitted: February 15, 2016
• First Submitted That Met QC Criteria: February 29, 2016
• First Posted (Estimate): March 4, 2016

Study Record Updates

• Last Update Posted (Actual): March 20, 2019
• Last Update Submitted That Met QC Criteria: March 18, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Gastroenteritis; Domperidone; Pediatric participants
• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Vomiting; Gastroenteritis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dopamine Agents; Dopamine Antagonists; Domperidone
• Other Study ID Numbers: CR107501; R033812GTS3001 (Other Identifier: Janssen-Cilag International NV); 2015-002923-24 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No