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Prucalopride Prior to Small Bowel Capsule Endoscopy

NCT02806206 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2016-07-15

No results posted yet for this study

Summary

Small bowel capsule endoscopy is a test used to investigate for any abnormalities in the small bowel. The small bowel is about 4 meters long. The battery time of the capsule is about 8 hours. During this time the capsule takes pictures as it passes through the small bowel. In about 15-20% of capsule tests the battery expires before the capsule passes through the entire small bowel into the colon. Incomplete tests indicate that a variable portion of small bowel was not visualized. Incomplete tests are associated with potential missing of abnormalities in the portion of small bowel that was not reached. The capsule test may often required to be repeated but the problem of incomplete examination may persist. At present no medication has been approved to increase the rate of complete capsule tests.

Prucalopride is a medication that has been approved in Canada and Europe for the treatment of chronic idiopathic constipation. Animal and human studies suggested that prucalopride may enhance the movement of the stomach and the small bowel. A recent presentation at a medical meeting suggested that prucalopride may accelerate the passage of the capsule camera through the small bowel without increasing the chance to miss a lesion in the small bowel.

The purpose of this study is to asses if the administration of a single dose of prucalopride is going to decrease the time required by the capsule to move through the small bowel.

Conditions

  • Gastrointestinal Hemorrhage
  • Crohn Disease
  • Celiac Disease
  • Intestinal Diseases
  • Inflammatory Bowel Diseases

Interventions

DRUG

Prucalopride

A single 2 mg oral dose of prucalopride will be given to each study participant just before the ingestion of the capsule endoscopy pill.

DRUG

Placebo

A single dose of a placebo pill will be given to each study participant just before the ingestion of the capsule endoscopy pill.

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Fergal Donnellan, MD · Division of Gastroenterology, University of British Columbia

  • Majid Alsahafi, MD · Division of Gastroenterology, University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02806206 on ClinicalTrials.gov