Bowel Cleansing Clinical Trial
Official title:
Prucalopride + Prucalopride Booster vs. Prucalopride + Picosalax Booster for the Colon Capsule
Verified date | February 2017 |
Source | Queen's University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 the colon but also needs to provide propulsion. Most published studies
have used medications as part of their regime that are not available in parts of North
America (ex. sodium phosphate) and have shown poor test completion, bowel preparation and
polyp detection rates.
Objective: In this study a bowel preparation for the colon capsule is proposed that uses
medications approved for use in Canada that may provide a better preparation quality and
better completion rates.
Methods: Patients who are being referred for a colonoscopy will be recruited to participate
in the study. They will all receive split-dose polyethylene glycol (PEG) for bowel
preparation. They will be randomized to receive either 1) Prucalopride 2mg daily for four
days, 2) Prucalopride 2mg daily for four days plus a Prucalopride booster, or 3)
Prucalopride 2mg for four days plus 1 and 1/2 sachets of Picosalax boosters for the colon
capsule study. The day after the colon capsule they will drink PEG ( 2 Liters) at 5am -or
approx 4hrs prior to procedure time and return for a colonoscopy. The colon capsule results
will be reviewed by two endoscopists experienced in video capsule endoscopy who will assess
the bowel preparation using a previously defined scale and examine for polyps. We propose
that administering Prucalopride daily for 4 days will increase intestinal motility and
improve colon capsule completion rates and a booster dose of Picosalax will improve colon
capsule completion rates compared to prucalopride by itself.
Status | Completed |
Enrollment | 60 |
Est. completion date | October 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Patients between the ages of 18-75 being referred for colonoscopy Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Hotel Dieu Hospital | Kingston | Ontario |
Lead Sponsor | Collaborator |
---|---|
Queen's University | Hotel Dieu Hospital, Janssen Inc. |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess the quality of the bowel preparations | Colon capsule bowel prep assessed with previously used scale completed by designated gastroenterologists. Colonoscopy bowel prep assessed by completion of Aronchick Scale by endoscopist performing procedure. |
Day of colon capsule procedure and day of colonoscopy | |
Secondary | Tolerance of Bowel Preparation with survey | Day of colonoscopy | ||
Secondary | Gastric, small bowel and colon transit time | Day of colon capsule |
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