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

Phase 3TerminatedNCT02699385

Janssen-Cilag International NV10 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Gastroenteritis

Interventions

Oral Rehydration TherapyOTHER

Each participants will initiate ORT in the physician's office on Day 1.

DomperidoneDRUG

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.

PlaceboDRUG

Each participants will receive placebo oral suspension thrice daily for up to 7 days.

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 12 Years

Medical Language ↔ Plain English

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

Locations (29)

Unnamed facility

Gröbming, Austria

Unnamed facility

Salzburg, Austria

Outcomes

Primary Outcomes

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.

Time frame: 48 Hours

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to Day 7

Data from ClinicalTrials.gov

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