Improving Bowel Preparation for the Colon Capsule
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Received Date ICMJE | July 30, 2012 | ||||||||
Last Updated Date | August 1, 2012 | ||||||||
Start Date ICMJE | July 2012 | ||||||||
Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
|
||||||||
Original Primary Outcome Measures ICMJE |
|
||||||||
Change History | Complete list of historical versions of study NCT01655095 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
|
||||||||
Original Secondary Outcome Measures ICMJE |
|
||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Improving Bowel Preparation for the Colon Capsule | ||||||||
Official Title ICMJE | Improving Bowel Preparation for the Colon Capsule: Picosalax and Prucalopride vs. PEG and Prucalopride | ||||||||
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 2L 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. |
||||||||
Detailed Description | |||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 3 | ||||||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Diagnostic |
||||||||
Condition ICMJE |
|
||||||||
Intervention ICMJE |
|
||||||||
Study Arm (s) |
|
||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE | 20 | ||||||||
Estimated Completion Date | June 2013 | ||||||||
Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
Gender | Both | ||||||||
Ages | 18 Years to 75 Years | ||||||||
Accepts Healthy Volunteers | Yes | ||||||||
Contacts ICMJE |
|
||||||||
Location Countries ICMJE | Canada | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT01655095 | ||||||||
Other Study ID Numbers ICMJE | DMED-1478-12 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
Responsible Party | Lawrence Hookey, Queen's University | ||||||||
Study Sponsor ICMJE | Queen's University | ||||||||
Collaborators ICMJE | Gastrointestinal Diseases Research Unit | ||||||||
Investigators ICMJE |
|
||||||||
Information Provided By | Queen's University | ||||||||
Verification Date | August 2012 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |