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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01398020
First received: July 14, 2011
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Efficacy of Bowel Preparation
Ease of Bowel Preparation and Patient Tolerability
Drug: Standard Bowel Prep
Drug: 2L Bi-Peglyte Bowel Prep

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Official Title: Oral 2L Bi-PegLyte Versus 4L PegLyte Regimen for Outpatient Colonic Preparation: A Randomized, Non-Inferiority Open Trial

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Difference in Boston Bowel Preparation Scale between the two groups [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    This is an established rating scale to evaluate the quality of bowel prep. The ratings will be compared between the two groups.


Secondary Outcome 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 318
Study Start Date: July 2011
Study Completion Date: September 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard bowel prep
Subject will receive standard bowel prep prior to colonoscopy.
Drug: Standard Bowel Prep
Subjects will be asked to take 4L of Peglyte the day prior to procedure.
Experimental: 2L Bi-Peglyte
Subjects will be asked to take 2L Bi-Peglyte + 15mg bisacodyl for bowel prep the day before colonoscopy.
Drug: 2L Bi-Peglyte Bowel Prep
Subjects will be asked to take 2L Bi-Peglyte and 15mg bisacodyl the day prior to procedure.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 19 or older
  • Outpatient colonoscopy

Exclusion Criteria:

  • constipation
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01398020

Locations
Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z1Y6
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Robert A Enns, MD The University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01398020     History of Changes
Other Study ID Numbers: H11-00688
Study First Received: July 14, 2011
Last Updated: September 17, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Bowel Preparation
Patient comfort
Bi-Peglyte

ClinicalTrials.gov processed this record on July 24, 2014