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

NCT ID: NCT02699385

Last Updated: 2019-03-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-07
• Study Completion Date: 2017-08-03

Brief Summary

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.

Detailed 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.

Conditions

Gastroenteritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Oral Rehydration Therapy (ORT) + Domperidone

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.

Group Type: EXPERIMENTAL

Oral Rehydration Therapy

Intervention Type: OTHER

Each participants will initiate ORT in the physician's office on Day 1.

Domperidone

Intervention Type: DRUG

Each participants will receive Domperidone 0.25 milligram per killogram (mg/kg) of body weight of oral suspension thrice daily for up to 7 days.

Oral Rehydration Therapy + Placebo

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

Group Type: EXPERIMENTAL

Oral Rehydration Therapy

Intervention Type: OTHER

Each participants will initiate ORT in the physician's office on Day 1.

Placebo

Intervention Type: DRUG

Each participants will receive placebo oral suspension thrice daily for up to 7 days.

Interventions

Oral Rehydration Therapy

Each participants will initiate ORT in the physician's office on Day 1.

Intervention Type: OTHER

Domperidone

Each participants will receive Domperidone 0.25 milligram per killogram (mg/kg) of body weight of oral suspension thrice daily for up to 7 days.

Intervention Type: DRUG

Placebo

Each participants will receive placebo oral suspension thrice daily for up to 7 days.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag International NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag International NV Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag International NV

Locations

Gröbming, , Austria

Salzburg, , Austria

Vienna, , Austria

Brussels, , Belgium

Herbeumont, , Belgium

Massemen, , Belgium

Moorsel, , Belgium

Novosibirsk, , Russia

Saint Petersburg, , Russia

Cape Town, , South Africa

Durban, , South Africa

Krugersdorp, , South Africa

Middelburg, , South Africa

Newtown, , South Africa

Pietermaritzburg, , South Africa

Pretoria, , South Africa

Burriana, , Spain

Gandia, , Spain

Valencia, , Spain

Vic, , Spain

Barnsley, , United Kingdom

Ipswich, , United Kingdom

Maidstone, , United Kingdom

Middlesbrough, , United Kingdom

Nottingham, , United Kingdom

Oldham, , United Kingdom

Royal Tunbridge Wells, , United Kingdom

Staffordshire, , United Kingdom

Sutton in Ashfield, , United Kingdom

Countries

Austria; Belgium; Russia; South Africa; Spain; United Kingdom

References

Leitz G, Hu P, Appiani C, Li Q, Mitha E, Garces-Sanchez M, Gupta R. Safety and Efficacy of Low-dose Domperidone for Treating Nausea and Vomiting Due to Acute Gastroenteritis in Children. J Pediatr Gastroenterol Nutr. 2019 Oct;69(4):425-430. doi: 10.1097/MPG.0000000000002409.

Reference Type: DERIVED

PMID: 31181017 (View on PubMed)

Related Links

https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-002923-24/results

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

Other Identifiers

R033812GTS3001

Identifier Type: OTHER

Identifier Source: secondary_id

2015-002923-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR107501

Identifier Type: -

Identifier Source: org_study_id