Prucalopride + Prucalopride Booster vs. Prucalopride + Picosalax Booster for the Colon Capsule

Sponsor

Queen's University (Other)

Overall Status

Completed

CT.gov ID

NCT01864915

Collaborator

Hotel Dieu Hospital (Other), Janssen Inc. (Industry)

Enrollment

Location

Arms

Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Bowel Cleansing Colon Capsule Completion Times	Drug: Prucalopride Procedure: Colon Capsule	Phase 3

Detailed Description

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

Prucalopride + Prucalopride Booster vs. Prucalopride + Picosalax Booster for the Colon Capsule

Study Start Date :

Jun 1, 2013

Actual Primary Completion Date :

Oct 1, 2014

Actual Study Completion Date :

Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: No Booster-low dose prucalopride booster low dose prucalopride booster arm	Drug: Prucalopride Prucalopride 2mg daily starting three days before the colon capsule study (total of 4 doses with the last at 0800hrs on day of colon capsule study) Other Names: RESTORAN Procedure: Colon Capsule Colon capsule procedure performed day prior to colonoscopy, at 0800 hrs on day 4.
Experimental: Prucalopride Booster-high dose prucalopride booster additional 2mg prucalopride at time of capsule ingestion	Drug: Prucalopride Prucalopride 2mg daily starting three days before the colon capsule study (total of 4 doses with the last at 0800hrs on day of colon capsule study) Other Names: RESTORAN Procedure: Colon Capsule Colon capsule procedure performed day prior to colonoscopy, at 0800 hrs on day 4.
Experimental: Picosalax Booster Arm One sachet of Picosalax 2hrs after capsule ingestion and 1/2 sachet at 4 hrs after swallowing colon capsule.	Drug: Prucalopride Prucalopride 2mg daily starting three days before the colon capsule study (total of 4 doses with the last at 0800hrs on day of colon capsule study) Other Names: RESTORAN Procedure: Colon Capsule Colon capsule procedure performed day prior to colonoscopy, at 0800 hrs on day 4.

Arm

Intervention/Treatment

Experimental: No Booster-low dose prucalopride booster

low dose prucalopride booster arm

Drug: Prucalopride

Prucalopride 2mg daily starting three days before the colon capsule study (total of 4 doses with the last at 0800hrs on day of colon capsule study)

Other Names:

RESTORAN

Procedure: Colon Capsule

Colon capsule procedure performed day prior to colonoscopy, at 0800 hrs on day 4.

Experimental: Prucalopride Booster-high dose prucalopride booster

additional 2mg prucalopride at time of capsule ingestion

Drug: Prucalopride

Prucalopride 2mg daily starting three days before the colon capsule study (total of 4 doses with the last at 0800hrs on day of colon capsule study)

Other Names:

RESTORAN

Procedure: Colon Capsule

Colon capsule procedure performed day prior to colonoscopy, at 0800 hrs on day 4.

Experimental: Picosalax Booster Arm

One sachet of Picosalax 2hrs after capsule ingestion and 1/2 sachet at 4 hrs after swallowing colon capsule.

Drug: Prucalopride

Prucalopride 2mg daily starting three days before the colon capsule study (total of 4 doses with the last at 0800hrs on day of colon capsule study)

Other Names:

RESTORAN

Procedure: Colon Capsule

Colon capsule procedure performed day prior to colonoscopy, at 0800 hrs on day 4.

Outcome Measures

Primary Outcome Measures

To assess the quality of the bowel preparations [Day of colon capsule procedure and day of colonoscopy]
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.

Secondary Outcome Measures

Tolerance of Bowel Preparation with survey [Day of colonoscopy]
Gastric, small bowel and colon transit time [Day of colon capsule]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.