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

NCT00410215 | Completed Phase 4

• 1 other identifier: hookey picosalax
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonoscopy

Outcome Measures

Primary Outcomes (1)

• Ottawa Bowel Preparation scale

  At Colonoscopy.

Secondary Outcomes (2)

• Tolerance-Likert scale questionnaire

  After Preparation.

• Safety Hemodynamics, Blood Chemistry

  After Preparation.

Study Arms (3)

1

ACTIVE COMPARATOR

sodium phosphate

Drug: sodium phosphate

2

ACTIVE COMPARATOR

picosalax

Drug: picosalax

3

ACTIVE COMPARATOR

picosalax plus bisacodyl

Drug: picosalax plus bisacodyl

Interventions

picosalax plus bisacodyl DRUG

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

3

picosalax DRUG

two sachets of picosalax taken orally the day prior to colonoscopy

2

sodium phosphate DRUG

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consecutive male and non-pregnant female patients
• ≥ 18 years old
• who require outpatient colonoscopy will be approached to consider participation in the study.

You may not qualify if:

• ileus or bowel obstruction;
• previous colorectal surgery;
• renal impairment;
• pregnancy;
• recent (\<6 months) myocardial infarction or unstable angina.

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Hotel Dieu Hospital

Kingston, Ontario, K7L 5G2, Canada

Location

MeSH Terms

Interventions

Bisacodyl; sodium phosphate

Intervention Hierarchy (Ancestors)

Cresols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Lawrence C Hookey, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 8, 2006
• First Posted: December 12, 2006
• Study Start: February 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: September 22, 2015

Record last verified: 2015-09

Locations

CA (1)