EUCTR2015-002923-24-BEActive, not recruitingPhase 1
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
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 480
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
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