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

Phase 1

• Conditions: ausea and Vomiting Due to Acute Gastroenteritis; MedDRA version: 18.1Level: LLTClassification code 10066762Term: Acute gastroenteritisSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2015-002923-24-ES
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-18
• Last Update Posted: 16 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 480

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

- 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