Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
20 participants
INTERVENTIONAL
2012-07-31
2012-10-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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PEG and Prucalopride
PEG
PEG 2L at 1800hrs the night before the test and 2L at 0500hrs the morning of the test.
Prucalopride
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.
Colon capsule
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.
Colonoscopy
At 1500hrs on the day of the test all individuals will return to the endoscopy unit for a colonoscopy.
Picosalax and Prucalopride
Prucalopride
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.
Picosalax
One sachet at 1800hrs the night before the test One sachet at 0500hrs the day of the test
Bisacodyl
Bisacodyl 10mg in the evening three nights before the procedure and 10mg again two nights before the procedure.
Colon capsule
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.
Colonoscopy
At 1500hrs on the day of the test all individuals will return to the endoscopy unit for a colonoscopy.
Interventions
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PEG
PEG 2L at 1800hrs the night before the test and 2L at 0500hrs the morning of the test.
Prucalopride
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.
Picosalax
One sachet at 1800hrs the night before the test One sachet at 0500hrs the day of the test
Bisacodyl
Bisacodyl 10mg in the evening three nights before the procedure and 10mg again two nights before the procedure.
Colon capsule
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.
Colonoscopy
At 1500hrs on the day of the test all individuals will return to the endoscopy unit for a colonoscopy.
Eligibility Criteria
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Inclusion Criteria
* Patients being referred for colonoscopy
Exclusion Criteria
* 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
18 Years
75 Years
ALL
Yes
Sponsors
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Hotel Dieu Hospital (Gastrointestinal Diseases Research Unit)
UNKNOWN
Queen's University
OTHER
Responsible Party
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Dr. Lawrence Hookey
Principal Investigator
Principal Investigators
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Lawrence Hookey
Role: PRINCIPAL_INVESTIGATOR
Queens University
Darlene Brady
Role: STUDY_DIRECTOR
Queens University
Locations
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Hotel Dieu Hospital
Kingston, Ontario, Canada
Countries
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Other Identifiers
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DMED-1478-12
Identifier Type: -
Identifier Source: org_study_id