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