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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02699385 |
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Date of registration:
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15/02/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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 |
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Date of first enrolment:
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December 7, 2015 |
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Target sample size:
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10 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02699385 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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Austria
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Belgium
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Portugal
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Russian Federation
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South Africa
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Spain
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United Kingdom
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Contacts
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Name:
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Janssen-Cilag International NV Clinical Trial |
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Address:
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Telephone:
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Email:
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Affiliation:
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Janssen-Cilag International NV |
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Key inclusion & exclusion criteria
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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
Age minimum:
6 Months
Age maximum:
12 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Gastroenteritis
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Intervention(s)
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Drug: Placebo
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Drug: Domperidone
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Other: Oral Rehydration Therapy
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Primary Outcome(s)
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Percentage of Participants With No Vomiting Episode Within the First 48 Hours of the First Treatment Administration
[Time Frame: 48 Hours]
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Secondary Outcome(s)
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Change From Baseline in Weight at Day 2
[Time Frame: Baseline and Day 2]
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Change From Baseline in Hydration Score at Day 2
[Time Frame: Baseline and Day 2]
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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
[Time Frame: Up to Day 7]
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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
[Time Frame: Up to Day 7]
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Percentage of Participants Referred to an Emergency Room/Hospital for Treatment Within the 7 Day Treatment Period
[Time Frame: Day 7]
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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
[Time Frame: Up to Day 7]
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Time to Last Study Medication Within the 7 Day Treatment Period
[Time Frame: Day 7]
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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
[Time Frame: Day 7]
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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
[Time Frame: Up to Day 7]
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Percentage of Participants Who Have No Episode of Vomiting Within the 7 Day Treatment Period After the First Treatment Administration
[Time Frame: Day 7]
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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
[Time Frame: Up to Day 7]
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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
[Time Frame: 48 Hours]
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Percentage of Participants Stopping Study Medication Early Due to Vomiting-Free for 24 Hours Within the 7 Day Treatment Period
[Time Frame: Day 7]
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Percentage of Participants Taking a Rescue Medication Within the 7 Day Treatment Period
[Time Frame: Day 7]
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Time-to-Last Vomiting Within the 7 Day Period After the First Treatment Administration
[Time Frame: Day 7]
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Secondary ID(s)
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2015-002923-24
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CR107501
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R033812GTS3001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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