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

Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00410215
• Other study ID #: hookey picosalax
• Status: Completed
• Phase: Phase 4
• First received: December 8, 2006
• Last updated: September 18, 2015
• Start date: February 2006
• Est. completion date: January 2008

Study information

• Verified date: September 2015
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Drug:
• picosalax plus bisacodyl
10 mg bisacodyl three and two nights prior to colonoscopy, followed by two sachets picosalax
• picosalax
two sachets of picosalax taken orally the day prior to colonoscopy
• sodium phosphate
two 45 ml bottles of sodium phosphate the day prior to colonoscopy

Locations

Country	Name	City	State
Canada	Hotel Dieu Hospital	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ottawa Bowel Preparation scale		At Colonoscopy.	No
Secondary	Tolerance-Likert scale questionnaire		After Preparation.	No
Secondary	Safety Hemodynamics, Blood Chemistry		After Preparation.	Yes