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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01398020
First Posted: July 20, 2011
Last Update Posted: September 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of British Columbia
  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 (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 ]
    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 ]
    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.


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

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 19 or older
  • Outpatient colonoscopy

Exclusion Criteria:

  • constipation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01398020     History of Changes
Other Study ID Numbers: H11-00688
First Submitted: July 14, 2011
First Posted: July 20, 2011
Last Update Posted: September 19, 2013
Last Verified: September 2013

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