Status:
COMPLETED
Prucalopride + Prucalopride Booster vs. Prucalopride + Picosalax Booster for the Colon Capsule
Lead Sponsor:
Queen's University
Collaborating Sponsors:
Hotel Dieu Hospital
Janssen Inc.
Conditions:
Bowel Cleansing
Colon Capsule Completion Times
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Colon capsule endoscopy is a new technology that is a noninvasive method of examining the large bowel. The bowel preparation required for this test differs from colonoscopy in that it needs to clean t...
Detailed Description
Colon capsule endoscopy is a new technology that is a noninvasive method of examining the large bowel. The bowel preparation required for this test differs from colonoscopy in that it needs to clean t...
Eligibility Criteria
Inclusion
- Patients between the ages of 18-75 being referred for colonoscopy
Exclusion
- symptoms of dysphagia or any problems with swallowing, bowel obstruction or ileus, known stricture or fistula, inflammatory bowel disease, previous small or large bowel surgery, severe gastroparesis or motility disorder, severe renal impairment ( defined as lab test result eGFR ie. estimated Glomerular Filtration Rate less than 55 within three months of study), congestive heart failure (NYHA III or IV), ischemic heart disease (acute event in the last 6mths), decompensated cirrhosis or severe hepatic dysfunction (ascites or known lab test INR\>2), history of serious arrhythmia or any other severe and clinically unstable concomitant disease (eg. lung disease, neurological or psychiatric disorder, cancer, AIDS and other endocrine disorder) ,diabetics on treatment with insulin or hypoglycemic, pregnant or nursing women, galactose intolerance (since the tablets contain lactose monohydrate, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose/galactose malabsorption must not take this medicinal product.) or known hypersensitivity to the drug or to any ingredient in the formulation (each 2mg tablet contains prucalopride 2 mg. Nonmedicinal ingredients: tablet core: lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate; coating: hypromellose, lactose monohydrate, triacetin, titanium dioxide, macrogol 3000, iron oxide red, iron oxide yellow, and FD\&C Blue No. 2 Aluminum Lake) Females of child bearing potential who are unwilling to use appropriate birth control methods during the study will not be able to participate in this clinical trial.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01864915
Start Date
June 1 2013
End Date
October 1 2014
Last Update
February 16 2017
Active Locations (1)
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1
Hotel Dieu Hospital
Kingston, Ontario, Canada, K7L 5V7