Improving Bowel Preparation for the Colon Capsule

NCT01655095 | Completed Phase 3 DMC

• 1 other identifier: DMED-1478-12
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Colon capsule endoscopy is a technology that has been developed as a noninvasive method of examining the large bowel. The biggest limitation to its use has been finding a bowel preparation that will both clean the colon adequately for good visualization of the mucosa and also help propel the capsule through the colon. Most studies have been conducted in Europe using bowel preparation medications that are not approved for use in North America. The purpose of this study is to compare a combination of polyethylene glycol (PEG) and prucalopride to Picosalax and prucalopride to determine which regime will give a better colon cleanse for the colon capsule. Both PEG and Picosalax are bowel preparations that are used routinely for colonoscopy in Canada. Prucalopride is a new medication recently approved for use in Canada which improves intestinal motility and should help with colon capsule transit. Patients who are being referred for colonoscopy will be enrolled in the study and randomized to one of the bowel preparation regimes. They will undergo a split-dose bowel preparation with either PEG or Picosalax, which is routine for colonoscopy. As part of the standard bowel preparation, patients randomized to the Picosalax group will take dulcolax three nights before the test and then again two nights before the test. The evening before the test patients will take either PEG 2L or one sachet of Picosalax. The following morning they will take another dose of either PEG (2 Liter container) or one sachet of Picosalax. They will then ingest the colon capsule and a dose of Prucalopride that morning. After 7 hours they will return to the endoscopy unit where they will undergo a colonoscopy, which is the standard of care for examination of the colon. The images from the colon capsule will be reviewed and the quality of bowel preparation will be graded using a previously validated scale. It is hypothesized that the Picosalax and prucalopride regime will give a better cleanse for the colon than PEG and prucalopride as there will be less turbid fluid in the colon and allow for a better view of the mucosa. Polyp detection and abnormalities of the mucosa detected with the colon capsule will also be compared to polyps and abnormalities detected at the time of colonoscopy.

Conditions

Quality of Bowel Preparation for the Colon Capsule; Colon Capsule Completion Rates; Colon Capsule Polyp Detection

Keywords

Colon capsule; Picosalax; PEG; Prucalopride

Outcome Measures

Primary Outcomes (2)

• Assessment of the Quality of the Bowel Preparation using a previously defined scale.

  Cleansing Scale: * Poor: Mucosa obscured by opaque debris or turbid fluid * Fair: Portion of the mucosa obscured by turbid fluid and/or debris preventing visualization of polyps \>5mm in size * Good: Fluid was clear and small pieces of debris not obscuring polyps \>5mm * Excellent: Fluid was clear and either free of debris or only small pieces Bubble effect scale: * Significant: Bubbles interfere with the examination, \>10% surface area obscured by bubbles. * Insignificant: No bubbles or bubbles that do not interfere with the examination, \<10% of surface area obscured by bubbles.

  Assessed at the time of review of the colon capsule images (from ingestion of capsule until the capsule is passed or the battery runs out--max 10 hrs) and at the time of colonoscopy on the same day (using a previously defined scale as described)

• Number of individuals who have a complete colon capsule study (ie. pass the colon capsule prior to colonoscopy)

  Assessed during the time of colon capsule image review

Secondary Outcomes (3)

• Assessment of patient tolerance of the bowel preparations.

  Assessed at the time of colon capsule ingestion (will cover time period from beginning of bowel preparation, as previously described, to ingestion of the colon capsule)

• Gastric emptying and small and large bowel transit time

  Assessed at the time the colon capsule images are reviewed (will be monitored from time of capsule ingestion until capsule is expelled or battery runs out--max 10 hours)

• Comparison of accurate identification of mucosal changes (ie. inflammation) and polyp detection with colonoscopy.

  Determined at the time of review of the colon capsule images (assessed from time of capsule ingestion until capsule is expelled or battery runs out--max. 10 hours) and assessed during the colonoscopy the same day.

Study Arms (2)

PEG and Prucalopride

EXPERIMENTAL

Drug: PEG; Drug: Prucalopride; Procedure: Colon capsule; Procedure: Colonoscopy

Picosalax and Prucalopride

EXPERIMENTAL

Drug: Prucalopride; Drug: Picosalax; Drug: Bisacodyl; Procedure: Colon capsule; Procedure: Colonoscopy

Interventions

PEG DRUG

PEG 2L at 1800hrs the night before the test and 2L at 0500hrs the morning of the test.

PEG and Prucalopride

Prucalopride DRUG

Prucalopride 2mg will be administered at 0800hrs on the day of the test, at the same time the colon capsule is administered. Two hours later the position of the colon capsule will be assess with a Realtime Viewer. If the capsule has not reached the cecum a second dose of Prucalopride 2mg will be administered at that time.

PEG and Prucalopride; Picosalax and Prucalopride

Picosalax DRUG

One sachet at 1800hrs the night before the test One sachet at 0500hrs the day of the test

Picosalax and Prucalopride

Bisacodyl DRUG

Bisacodyl 10mg in the evening three nights before the procedure and 10mg again two nights before the procedure.

Picosalax and Prucalopride

Colon capsule PROCEDURE

The colon capsule will be ingested at 0800hrs the day of the test. Seven hours will be allowed for the capsule to clear the bowel. The images will be reviewed by two endoscopists with experience reading video capsule endoscopy.

PEG and Prucalopride; Picosalax and Prucalopride

Colonoscopy PROCEDURE

At 1500hrs on the day of the test all individuals will return to the endoscopy unit for a colonoscopy.

PEG and Prucalopride; Picosalax and Prucalopride

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients between the ages of 18 and 75
• Patients being referred for colonoscopy

You may not qualify if:

• Symptoms of dysphagia
• Bowel obstruction or ileus
• Known stricture or fistula
• Inflammatory bowel disease
• Previous small or large bowel surgery
• Severe gastroparesis or motility disorder
• Renal impairment (GFR\<55 within 3 months of study)
• Congestive heart failure (NYHA III or IV)
• Ischemic heart disease
• Cirrhosis or severe hepatic dysfunction (ascites or lab result INR\>2)
• History of serious arrhythmia
• Pregnancy

Sponsors & Collaborators

• Queen's University: lead
• Hotel Dieu Hospital (Gastrointestinal Diseases Research Unit): collaborator

Study Sites (1)

Hotel Dieu Hospital

Kingston, Ontario, Canada

Location

MeSH Terms

Interventions

prucalopride; Bisacodyl; Colonoscopy

Intervention Hierarchy (Ancestors)

Cresols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Lawrence Hookey

  Queens University

  PRINCIPAL INVESTIGATOR

• Darlene Brady

  Queens University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 30, 2012
• First Posted: August 1, 2012
• Study Start: July 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: December 3, 2015

Record last verified: 2015-09

Locations

CA (1)