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

NCT ID: NCT00410215

Last Updated: 2015-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 315 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2008-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

sodium phosphate

Group Type: ACTIVE_COMPARATOR

sodium phosphate

Intervention Type: DRUG

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

2

picosalax

Group Type: ACTIVE_COMPARATOR

picosalax

Intervention Type: DRUG

two sachets of picosalax taken orally the day prior to colonoscopy

3

picosalax plus bisacodyl

Group Type: ACTIVE_COMPARATOR

picosalax plus bisacodyl

Intervention Type: DRUG

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

Interventions

picosalax plus bisacodyl

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

Intervention Type: DRUG

picosalax

two sachets of picosalax taken orally the day prior to colonoscopy

Intervention Type: DRUG

sodium phosphate

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Lawrence Hookey

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lawrence C Hookey, MD

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

Hotel Dieu Hospital

Kingston, Ontario, Canada

Countries

Canada

Other Identifiers

hookey picosalax

Identifier Type: -

Identifier Source: org_study_id