A Randomized Controlled Trial Comparing Picosalax and Oral Sodium Phosphate for Colon Cleansing Prior to Colonoscopy

September 18, 2015 updated by: Dr. Lawrence Hookey, Queen's University

Colon cleansing prior to colonoscopy is critically important to ensure effective colonoscopy for colon cancer screening, which is now widespread in North America. Currently available colon cleansing agents are limited either by potential safety concerns or significant limitations in the ability of patients to tolerate the preparation. Pico-salax has recently been introduced in Canada as an alternative agent and is being used more and more widely despite an almost complete lack of clinical data supporting efficacy and safety. This study will establish the relative efficacy and patient tolerability of this agent and its safety profile. This is a very important, practical issue which continues to challenge gastroenterologists, surgeons, internists, family doctors and thousands of their patients in Canada on a daily basis.

Anecdotal evidence suggests that the efficacy of pico-salax when used as a sole agent may not be as efficacious as oral sodium phosphate. Hence, our hypothesis is that the combination of pico-salax and bisacodyl will provide the most efficacious bowel preparation in comparison with oral sodium phosphate and pico-salax alone, while being equally if not better tolerated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, investigator blinded clinical trial assessing the cleansing efficacy (using the Ottawa Bowel Preparation scale) and tolerance of three bowel cleansing regimens, two of which involve pico-salax.

Study Type

Interventional

Enrollment (Actual)

315

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
        • Hotel 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Consecutive male and non-pregnant female patients
  • ≥ 18 years old
  • who require outpatient colonoscopy will be approached to consider participation in the study.

Exclusion Criteria:

  • ileus or bowel obstruction;
  • previous colorectal surgery;
  • renal impairment;
  • pregnancy;
  • recent (<6 months) myocardial infarction or unstable angina.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
sodium phosphate
Drug: sodium phosphate
two 45 ml bottles of sodium phosphate the day prior to colonoscopy
Active Comparator: 2
picosalax
Drug: picosalax
two sachets of picosalax taken orally the day prior to colonoscopy
Active Comparator: 3
picosalax plus bisacodyl
Drug: picosalax plus bisacodyl
10 mg bisacodyl three and two nights prior to colonoscopy, followed by two sachets picosalax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ottawa Bowel Preparation scale
Time Frame: At Colonoscopy.
At Colonoscopy.

Secondary Outcome Measures

Outcome Measure
Time Frame
Tolerance-Likert scale questionnaire
Time Frame: After Preparation.
After Preparation.
Safety Hemodynamics, Blood Chemistry
Time Frame: After Preparation.
After Preparation.

Collaborators and Investigators

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

Sponsor

Queen's University

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

February 1, 2006

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

December 8, 2006

First Submitted That Met QC Criteria

December 8, 2006

First Posted (Estimate)

December 12, 2006

Study Record Updates

Last Update Posted (Estimate)

September 22, 2015

Last Update Submitted That Met QC Criteria

September 18, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • hookey picosalax

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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