NCT00410215

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 315 (actual)
• Sponsor: Queen's University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Colonoscopy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2006-02-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2006-12-12
• Last updated: 2015-09-22

Locations

1 site across 1 country: Canada