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

Janssen (J&J Innovative Medicine)

Status and phase: Terminated; Phase 3

Conditions: Gastroenteritis

Treatments: Drug: Domperidone; Other: Oral Rehydration Therapy; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02699385

CR107501

2015-002923-24 (EudraCT Number)

R033812GTS3001 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 10 patients

Sex: All

Ages: 6 months to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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10 participants in 2 patient groups

Oral Rehydration Therapy (ORT) + Domperidone

Experimental group

Description:

Each participants will initiate ORT in the physician's office and domperidone 0.25 milligram per kilogram (mg/kg) of body weight of oral suspension thrice daily for up to 7 days.

Treatment:

Drug: Domperidone

Other: Oral Rehydration Therapy

Oral Rehydration Therapy + Placebo

Experimental group

Description:

Each participants will initiate ORT in the physician's office and placebo oral suspension thrice daily for up to 7 days.

Treatment:

Drug: Placebo

Other: Oral Rehydration Therapy