Prucalopride Prior to Small Bowel Capsule Endoscopy

NCT02806206 | Unknown Phase 4

• 1 other identifier: H16-01345
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Small bowel transit time

  The calculated time from the first duodenal image to the first cecal image. The capsule images will be collected when the capsule is finished recording, approximately 10 hours post-dose.

  10 hours post dose

Secondary Outcomes (3)

• Gastric transit time

  10 hours post dose

• Small bowel completion rate

  10 hours post dose

• Diagnostic yield

  10 hours post dose

Study Arms (2)

Drug: Prucalopride

EXPERIMENTAL

A single 2 mg dose of prucalopride before ingesting the capsule endoscopy pill.

Drug: Prucalopride

Drug: Placebo

PLACEBO COMPARATOR

A placebo pill just before ingesting the capsule endoscopy pill.

Drug: Placebo

Interventions

Prucalopride DRUG

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

Also known as: Restoran

Drug: Prucalopride

Placebo DRUG

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

Also known as: Sugar pill

Drug: Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Appropriate indication for small bowel capsule endoscopy.
• Age 19 or older.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Conditions

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

Interventions

prucalopride; Sugars

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastroenteritis; Malabsorption Syndromes; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• Fergal Donnellan, MD

  Division of Gastroenterology, University of British Columbia

  PRINCIPAL INVESTIGATOR

• Majid Alsahafi, MD

  Division of Gastroenterology, University of British Columbia

  STUDY DIRECTOR

Central Study Contacts

Fergal Donnellan, MD

CONTACT

6048755474; Fergal.Donnellan@vch.ca

Nazira Chatur, MD

CONTACT

6048755039; nazchatur@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: June 20, 2016
• Study Start: July 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: July 15, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)