Comparing 2L Bi-Pegyte to 4L PegLyte Regiments for Outpatient Colonic Preparation

Overview

The investigators wish to compare the efficacy and patient tolerability of a preparation consisting of 2L Bi-Peglyte plus 15mg of bisacodyl vs the standard preparation of 4L Peglyte. The investigators hypothesize that 2L Bi-Peglyte with 15mg bisacodyl will show higher efficacy and tolerability.

Full Title of Study: “Oral 2L Bi-PegLyte Versus 4L PegLyte Regimen for Outpatient Colonic Preparation: A Randomized, Non-Inferiority Open Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: September 2012

Interventions

  • Drug: Standard Bowel Prep
    • Subjects will be asked to take 4L of Peglyte the day prior to procedure.
  • Drug: 2L Bi-Peglyte Bowel Prep
    • Subjects will be asked to take 2L Bi-Peglyte and 15mg bisacodyl the day prior to procedure.

Arms, Groups and Cohorts

  • Active Comparator: Standard bowel prep
    • Subject will receive standard bowel prep prior to colonoscopy.
  • Experimental: 2L Bi-Peglyte
    • Subjects will be asked to take 2L Bi-Peglyte + 15mg bisacodyl for bowel prep the day before colonoscopy.

Clinical Trial Outcome Measures

Primary Measures

  • Difference in Boston Bowel Preparation Scale between the two groups
    • Time Frame: 30 minutes
    • This is an established rating scale to evaluate the quality of bowel prep. The ratings will be compared between the two groups.

Secondary Measures

  • Difference in the number of participants who develop distress symptoms from bowel prep (and the type) between the two groups
    • Time Frame: 20 hours
    • Number of participants who develop distress symptoms from bowel prep, and the type of distress symptoms will be compared between the two groups
  • Difference in the absolute number/percentage of participants in the two groups who find the bowel prep experience easy, acceptable, difficult, very difficult, or unable to complete.
    • Time Frame: 20
    • Participants will be asked to rate their bowel prep experience (based on ease of use) on a Likert scale. The number of participants in each level will subsequently be quantified (n, %) and compared between the two groups.

Participating in This Clinical Trial

Inclusion Criteria

  • Age 19 or older – Outpatient colonoscopy Exclusion Criteria:

  • constipation

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of British Columbia
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Robert A Enns, MD, Principal Investigator, The University of British Columbia

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