Prucalopride + Prucalopride Booster vs. Prucalopride + Picosalax Booster for the Colon Capsule
Condition: Bowel Cleansing; Colon Capsule Completion Times
Study type: Interventional
Phase: Phase 3

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.
    

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 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
    

Intervention name(s): Prucalopride; Colon Capsule
Intervention type(s): Drug; Procedure
Intervention description(s): 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); Colon capsule procedure performed day prior to colonoscopy, at 0800 hrs on day 4.
Other intervention name(s): RESTORAN
Intervention MeSH terms: Prucalopride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: colon capsule; bowel preparation; booster; prucalopride; picosalax