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Completed

NCT Number: NCT00410215

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hotel Dieu Hospital

Kingston, Ontario, K7L 5G2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

picosalax plus bisacodyl

Drug

10 mg bisacodyl three and two nights prior to colonoscopy, followed by two sachets picosalax

Picosalax

Drug

two sachets of picosalax taken orally the day prior to colonoscopy

sodium phosphate

Drug

two 45 ml bottles of sodium phosphate the day prior to colonoscopy

Primary outcomes

  1. Ottawa Bowel Preparation scale

    Time frame: At Colonoscopy.

Secondary outcomes

  1. Tolerance-Likert scale questionnaire

    Time frame: After Preparation.

  2. Safety Hemodynamics, Blood Chemistry

    Time frame: After Preparation.

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Dec 12, 2006
Registry last updated
Sep 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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