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

NCT00410215 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 315

Last updated 2015-09-22

No results posted yet for this study

Summary

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.

Conditions

  • Colonoscopy

Interventions

DRUG

picosalax plus bisacodyl

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

DRUG

picosalax

two sachets of picosalax taken orally the day prior to colonoscopy

DRUG

sodium phosphate

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

Sponsors & Collaborators

  • Queen's University

    lead OTHER

Principal Investigators

  • Lawrence C Hookey, MD · Queen's University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2008-01-31
Completion
2008-01-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00410215 on ClinicalTrials.gov