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

NCT01864915 | Completed Phase 3 DMC

• 2 other identifiers: DMED 1578-13 HOOKEY9427-D2773-21C
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Bowel Cleansing; Colon Capsule Completion Times

Keywords

colon capsule; bowel preparation; booster; prucalopride; picosalax

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Tolerance of Bowel Preparation with survey

  Day of colonoscopy

• Gastric, small bowel and colon transit time

  Day of colon capsule

Study Arms (3)

No Booster-low dose prucalopride booster

EXPERIMENTAL

low dose prucalopride booster arm

Drug: Prucalopride; Procedure: Colon Capsule

Prucalopride Booster-high dose prucalopride booster

EXPERIMENTAL

additional 2mg prucalopride at time of capsule ingestion

Drug: Prucalopride; Procedure: Colon Capsule

Picosalax Booster Arm

EXPERIMENTAL

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

Drug: Prucalopride; Procedure: Colon Capsule

Interventions

Prucalopride DRUG

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)

Also known as: RESTORAN

No Booster-low dose prucalopride booster; Picosalax Booster Arm; Prucalopride Booster-high dose prucalopride booster

Colon Capsule PROCEDURE

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

No Booster-low dose prucalopride booster; Picosalax Booster Arm; Prucalopride Booster-high dose prucalopride booster

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between the ages of 18-75 being referred for colonoscopy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen's University: lead
• Hotel Dieu Hospital: collaborator
• Janssen Inc.: collaborator

Study Sites (1)

Hotel Dieu Hospital

Kingston, Ontario, K7L 5V7, Canada

Location

MeSH Terms

Interventions

prucalopride

Study Officials

• Lawrence Hookey

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 25, 2013
• First Posted: May 30, 2013
• Study Start: June 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: February 16, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)