A Study to Evaluate the Safety and Efficacy of Domperidone in Pediatric Participants With Nausea and Vomiting Due to Acute Gastroenteritis
- Conditions
- ausea and Vomiting Due to Acute GastroenteritisMedDRA version: 18.1Level: LLTClassification code 10066762Term: Acute gastroenteritisSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2015-002923-24-BE
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 480
- 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
- 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 & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>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
- Secondary Outcome Measures
Name Time Method