Back to resultsA Study to Evaluate the Safety and Efficacy of Domperidone in Pediatric Participants With Nausea and Vomiting Due to Acute Gastroenteritis
Primary Purpose
Gastroenteritis
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Oral Rehydration Therapy
Domperidone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Gastroenteritis focused on measuring Gastroenteritis, Domperidone, Pediatric participants
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Oral Rehydration Therapy (ORT) + Domperidone
Oral Rehydration Therapy + Placebo
Arm 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.
Each participants will initiate ORT in the physician's office and placebo oral suspension thrice daily for up to 7 days.
Outcomes
Primary Outcome Measures
Percentage of Participants With No Vomiting Episode Within the First 48 Hours of the First Treatment Administration
The vomiting episodes will be recorded for each participants in the eDiary.
Secondary Outcome Measures
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
The nausea episodes will be recorded in the eDiary.
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
The vomiting episodes will be recorded for each participants in the eDiary.
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
The nausea episodes will be recorded in the eDiary.
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
The vomiting episodes will be recorded for each participants in the eDiary.
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
The nausea episodes will be recorded in the eDiary.
Percentage of Participants Who Have No Episode of Vomiting Within the 7 Day Treatment Period After the First Treatment Administration
The vomiting episodes will be recorded for each participants in the eDiary.
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
The nausea episodes will be recorded in the eDiary.
Percentage of Participants Taking a Rescue Medication Within the 7 Day Treatment Period
If nausea, vomiting, or diarrhea worsens during the study and the investigator initiates rescue medication, the study medication will be discontinued.
Percentage of Participants Stopping Study Medication Early Due to Vomiting-Free for 24 Hours Within the 7 Day Treatment Period
The vomiting episodes will be recorded for each participants in the eDiary.
Time to Last Study Medication Within the 7 Day Treatment Period
Time taken to administer last study medication will be observed.
Percentage of Participants Referred to an Emergency Room/Hospital for Treatment Within the 7 Day Treatment Period
If nausea, vomiting, or diarrhea worsens during the study and admits the participant to the hospital for IV fluids, the study medication will be discontinued.
Time-to-Last Vomiting Within the 7 Day Period After the First Treatment Administration
The vomiting episodes will be recorded for each participants in the eDiary.
Change From Baseline in Hydration Score at Day 2
The severity of dehydration will be assessed using the Dehydration Score Assessment. a) Children under 24 months of age with a score range 7 to 10 points have mild dehydration and children with a score range of 11 to 17 points have moderate dehydration (only children under 24 months of age are evaluated for tears). b) Children 24 months of age or older with a score range of 6 to 9 points have mild dehydration and children with a score range of 10 to 15 points have moderate dehydration. and c) Children under 24 months of age with scores of 18 or more and children 24 months of age or older with scores of 16 or more are considered to be severely dehydrated and are excluded from the study.
Change From Baseline in Weight at Day 2
Weight will be measured to the nearest 100 grams in underwear (no diaper/nappy/training pants).
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
The diarrhea episodes will be recorded for each participant in the eDiary.
Full Information
NCT ID
NCT02699385
First Posted
February 15, 2016
Last Updated
March 18, 2019
Sponsor
Janssen-Cilag International NV
1. Study Identification
Unique Protocol Identification Number
NCT02699385
Brief Title
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
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
Study prematurely terminated upon recommendation of IDMC due to lack of efficacy.
Study Start Date
December 7, 2015 (Actual)
Primary Completion Date
August 3, 2017 (Actual)
Study Completion Date
August 3, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen-Cilag International NV
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroenteritis
Keywords
Gastroenteritis, Domperidone, Pediatric participants
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral Rehydration Therapy (ORT) + Domperidone
Arm Type
Experimental
Arm 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.
Arm Title
Oral Rehydration Therapy + Placebo
Arm Type
Experimental
Arm Description
Each participants will initiate ORT in the physician's office and placebo oral suspension thrice daily for up to 7 days.
Intervention Type
Other
Intervention Name(s)
Oral Rehydration Therapy
Intervention Description
Each participants will initiate ORT in the physician's office on Day 1.
Intervention Type
Drug
Intervention Name(s)
Domperidone
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Each participants will receive placebo oral suspension thrice daily for up to 7 days.
Primary Outcome Measure Information:
Title
Percentage of Participants With No Vomiting Episode Within the First 48 Hours of the First Treatment Administration
Description
The vomiting episodes will be recorded for each participants in the eDiary.
Time Frame
48 Hours
Secondary Outcome Measure Information:
Title
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
Description
The nausea episodes will be recorded in the eDiary.
Time Frame
48 Hours
Title
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
Description
The vomiting episodes will be recorded for each participants in the eDiary.
Time Frame
Up to Day 7
Title
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
Description
The nausea episodes will be recorded in the eDiary.
Time Frame
Up to Day 7
Title
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
Description
The vomiting episodes will be recorded for each participants in the eDiary.
Time Frame
Up to Day 7
Title
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
Description
The nausea episodes will be recorded in the eDiary.
Time Frame
Up to Day 7
Title
Percentage of Participants Who Have No Episode of Vomiting Within the 7 Day Treatment Period After the First Treatment Administration
Description
The vomiting episodes will be recorded for each participants in the eDiary.
Time Frame
Day 7
Title
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
Description
The nausea episodes will be recorded in the eDiary.
Time Frame
Day 7
Title
Percentage of Participants Taking a Rescue Medication Within the 7 Day Treatment Period
Description
If nausea, vomiting, or diarrhea worsens during the study and the investigator initiates rescue medication, the study medication will be discontinued.
Time Frame
Day 7
Title
Percentage of Participants Stopping Study Medication Early Due to Vomiting-Free for 24 Hours Within the 7 Day Treatment Period
Description
The vomiting episodes will be recorded for each participants in the eDiary.
Time Frame
Day 7
Title
Time to Last Study Medication Within the 7 Day Treatment Period
Description
Time taken to administer last study medication will be observed.
Time Frame
Day 7
Title
Percentage of Participants Referred to an Emergency Room/Hospital for Treatment Within the 7 Day Treatment Period
Description
If nausea, vomiting, or diarrhea worsens during the study and admits the participant to the hospital for IV fluids, the study medication will be discontinued.
Time Frame
Day 7
Title
Time-to-Last Vomiting Within the 7 Day Period After the First Treatment Administration
Description
The vomiting episodes will be recorded for each participants in the eDiary.
Time Frame
Day 7
Title
Change From Baseline in Hydration Score at Day 2
Description
The severity of dehydration will be assessed using the Dehydration Score Assessment. a) Children under 24 months of age with a score range 7 to 10 points have mild dehydration and children with a score range of 11 to 17 points have moderate dehydration (only children under 24 months of age are evaluated for tears). b) Children 24 months of age or older with a score range of 6 to 9 points have mild dehydration and children with a score range of 10 to 15 points have moderate dehydration. and c) Children under 24 months of age with scores of 18 or more and children 24 months of age or older with scores of 16 or more are considered to be severely dehydrated and are excluded from the study.
Time Frame
Baseline and Day 2
Title
Change From Baseline in Weight at Day 2
Description
Weight will be measured to the nearest 100 grams in underwear (no diaper/nappy/training pants).
Time Frame
Baseline and Day 2
Title
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
Description
The diarrhea episodes will be recorded for each participant in the eDiary.
Time Frame
Up to Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen-Cilag International NV Clinical Trial
Organizational Affiliation
Janssen-Cilag International NV
Official's Role
Study Director
Facility Information:
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
31181017
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.
Results Reference
derived
Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-002923-24/results
Description
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
Learn more about this trial
A Study to Evaluate the Safety and Efficacy of Domperidone in Pediatric Participants With Nausea and Vomiting Due to Acute Gastroenteritis
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