Clinical trial NCT02699385: A Study to Evaluate the Safety and Efficacy of Domperidone in Pediatric Participants With Nausea and Vomiting Due to Acute Gastroenteritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Gastroenteritis
Keywords: Gastroenteritis
Domperidone
Pediatric participants
Lead sponsor: Janssen-Cilag International NV
Sponsor class: INDUSTRY
First posted: 2016-03-04
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Participants With No Vomiting Episode Within the First 48 Hours of the First Treatment Administration
timeFrame: 48 Hours
Secondary outcomes:
measure: Percentage of Participants 4 Years of Age or Older Who Have No Episode of Nausea Within the First 48 Hours of the First Treatment Administration
timeFrame: 48 Hours
measure: Number of Vomiting Episodes for Participants Within the 0 to 24 Hour, Greater Than (>) 24 to 48 Hour, and >48 Hour to 7 Day Periods After the First Treatment Administration
timeFrame: Up to Day 7
measure: Number of Episodes of Nausea for Participants 4 Years of Age or Older Within the 0 to 24 Hour, >24 to 48 Hour, and >48 Hour to 7 Day Periods After the First Treatment Administration
timeFrame: Up to Day 7
measure: Percentage of Participants who Have No Episode of Vomiting Within the 0 to 24 Hour, >24 to 48 Hour, and >48 Hour to 7 Day Periods After the First Treatment Administration
timeFrame: Up to Day 7
measure: Percentage of Participants 4 Years of Age or Older Who Have No Episode of Nausea Within the 0 to 24 Hour, >24 to 48 Hour, and >48 Hour to 7 Day Periods After the First Treatment Administration
timeFrame: Up to Day 7
measure: Percentage of Participants Who Have No Episode of Vomiting Within the 7 Day Treatment Period After the First Treatment Administration
timeFrame: Day 7
measure: Percentage of Participants 4 Years of Age or Older Who Have No Episode of Nausea Within the 7 Day Treatment Period After the First Treatment Administration
timeFrame: Day 7
measure: Percentage of Participants Taking a Rescue Medication Within the 7 Day Treatment Period
timeFrame: Day 7
measure: Percentage of Participants Stopping Study Medication Early Due to Vomiting-Free for 24 Hours Within the 7 Day Treatment Period
timeFrame: Day 7
measure: Time to Last Study Medication Within the 7 Day Treatment Period
timeFrame: Day 7
measure: Percentage of Participants Referred to an Emergency Room/Hospital for Treatment Within the 7 Day Treatment Period
timeFrame: Day 7
measure: Time-to-Last Vomiting Within the 7 Day Period After the First Treatment Administration
timeFrame: Day 7
measure: Change From Baseline in Hydration Score at Day 2
timeFrame: Baseline and Day 2
measure: Change From Baseline in Weight at Day 2
timeFrame: Baseline and Day 2
measure: Percentage of Participants With Diarrhea Within 0 to 24 Hour, >24 to 48 Hour, >48 Hour to 7 Day, and 0 Hour to 7 Day Periods After the First Successful Treatment Administration
timeFrame: Up to Day 7
Other outcomes:
Locations:
city: Gröbming
country: Austria
city: Salzburg
country: Austria
city: Vienna
country: Austria
city: Wien N/A
country: Austria
city: Brussels
country: Belgium
city: Brussel
country: Belgium
city: Herbeumont
country: Belgium
city: Massemen
country: Belgium
city: Moorsel
country: Belgium
city: Novosibirsk
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St.Petersburg
country: Russian Federation
city: Cape Town
country: South Africa
city: Durban
country: South Africa
city: Krugersdorp
country: South Africa
city: Middelburg
country: South Africa
city: Newtown
country: South Africa
city: Pietermaritzburg
country: South Africa
city: Pretoria
country: South Africa
city: Borriana
country: Spain
city: Gandia
country: Spain
city: Valencia
country: Spain
city: Vic
country: Spain
city: Barnsley
country: United Kingdom
city: Ipswich
country: United Kingdom
city: Maidstone
country: United Kingdom
city: Middlesborough
country: United Kingdom
city: Nottingham
country: United Kingdom
city: Oldham
country: United Kingdom
city: Staffordshire
country: United Kingdom
city: Sutton In Ashfield
country: United Kingdom
city: Tunbridge Wells
country: United Kingdom
Study officials:
affiliation: Janssen-Cilag International NV
name: Janssen-Cilag International NV Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.