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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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8 August 2016 |
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Main ID: |
NCT02806206 |
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Date of registration:
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15/06/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Prucalopride Prior to Small Bowel Capsule Endoscopy
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Scientific title:
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The Effect of Prucalopride on Small Bowel Transit Time in Patients Undergoing Capsule Endoscopy: A Randomized Controlled Trial |
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Date of first enrolment:
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July 2016 |
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Target sample size:
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122 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02806206 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Canada
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Contacts
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Name:
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Fergal Donnellan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Division of Gastroenterology, University of British Columbia |
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Name:
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Fergal Donnellan, MD |
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Address:
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Telephone:
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6048755474 |
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Email:
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Fergal.Donnellan@vch.ca |
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Affiliation:
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Name:
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Majid Alsahafi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Division of Gastroenterology, University of British Columbia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Appropriate indication for small bowel capsule endoscopy.
- Age 19 or older.
Exclusion Criteria:
- Previous partial or complete gastric resection.
- Previous small bowel surgery in which a small bowel resection has been performed or
the normal anatomy has been altered.
- Presence of ileostomy.
- The requirement for endoscopic placement of the capsule endoscopy pill because of
dysphagia or gastroparesis.
- Severe renal impairment, defined by the requirement for dialysis.
- Pregnancy or breast feeding.
- Clinical or radiological suspicion of small bowel obstruction.
- Simultaneous use of a prokinetic agent within 5 days of the capsule endoscopy
examination.
- Clinical hypo- or hyperthyroidism.
- Known hypersensitivity to the study drug.
- Unwillingness to sign informed consent.
Age minimum:
19 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Gastrointestinal Hemorrhage
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Intestinal Diseases
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Crohn Disease
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Celiac Disease
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Inflammatory Bowel Diseases
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Intervention(s)
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Drug: Prucalopride
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Drug: Placebo
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Primary Outcome(s)
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Small bowel transit time
[Time Frame: 10 hours post dose]
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Secondary Outcome(s)
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Gastric transit time
[Time Frame: 10 hours post dose]
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Small bowel completion rate
[Time Frame: 10 hours post dose]
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Diagnostic yield
[Time Frame: 10 hours post dose]
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Secondary ID(s)
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H16-01345
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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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