A Randomized Controlled Trial Comparing Two Timing Regimens of Pico-salax for Colon Cleansing Prior to Colonoscopy

August 27, 2015 updated by: Dr. Lawrence Hookey, Queen's University

A Randomized Controlled Trial Comparing Two Timing Regimens of Pico-salax for Colon Cleansing Prior to Colonoscopy.

Pico-Salax is an osmotic and stimulant bowel cleansing agent used prior to colonoscopy. It is unknown whether splitting the doses (i.e. taking the second dose the morning of the colonoscopy) results in a better bowel cleansing, as research with other agents suggests this may be the case. This study aims to assess whether splitting the dose of Pico-Salax results in a better bowel cleansing than traditional dosing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 5G2
        • Hôtel Dieu Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • colonoscopy indicated

Exclusion Criteria:

  • congestive heart failure
  • ascites
  • renal failure
  • hyponatremia
  • previous intestinal surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Split Dose
Doses of Pico-Salax split: one dose administered the night prior to colonoscopy and the other dose administered the day of the procedure.
Drug: Split Dose Pico-Salax
One dose of Pico-Salax taken the evening prior to colonoscopy and the other the morning of the procedure.
Active Comparator: Traditional Dose
Both doses of Pico-Salax taken the evening prior to colonoscopy.
Drug: Pico-Salax
Both doses of Pico-Salax taken the evening prior to colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
bowel cleansing assessed by the Ottawa Bowel Preparation Scale
Time Frame: day of colonoscopy
day of colonoscopy

Secondary Outcome Measures

Outcome Measure
Time Frame
patient tolerance of preparation
Time Frame: day of colonoscopy
day of colonoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

April 20, 2009

First Submitted That Met QC Criteria

April 20, 2009

First Posted (Estimate)

April 21, 2009

Study Record Updates

Last Update Posted (Estimate)

August 31, 2015

Last Update Submitted That Met QC Criteria

August 27, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hookey Pico-Salax Timing

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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