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

This study has been completed.
Sponsor:
Information provided by:
Queen's University
ClinicalTrials.gov Identifier:
NCT00410215
First received: December 8, 2006
Last updated: November 2, 2009
Last verified: November 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Colonoscopy
 Drug: picosalax plus bisacodyl
Drug: picosalax
Drug: sodium phosphate
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing Picosalax and Oral Sodium Phosphate for Colon Cleansing Prior to Colonoscopy

Resource links provided by NLM:

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Ottawa Bowel Preparation scale [ Time Frame: At Colonoscopy. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerance-Likert scale questionnaire [ Time Frame: After Preparation. ] [ Designated as safety issue: No ]
  • Safety Hemodynamics, Blood Chemistry [ Time Frame: After Preparation. ] [ Designated as safety issue: Yes ]

Enrollment: 315
Study Start Date: February 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
sodium phosphate
 Drug: sodium phosphate
two 45 ml bottles of sodium phosphate the day prior to colonoscopy
Active Comparator: 2
picosalax
 Drug: picosalax
two sachets of picosalax taken orally the day prior to colonoscopy
Active Comparator: 3
picosalax plus bisacodyl
 Drug: picosalax plus bisacodyl
10 mg bisacodyl three and two nights prior to colonoscopy, followed by two sachets picosalax

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00410215

Locations
Canada, Ontario
Hotel Dieu Hospital
Kingston, Ontario, Canada, K7L 5G2
Sponsors and Collaborators
Queen's University
Investigators
Principal Investigator: Lawrence C Hookey, MD Queen's University
  More Information

No publications provided

Responsible Party: Dr. Lawrence Hookey, Queen's University
ClinicalTrials.gov Identifier: NCT00410215     History of Changes
Other Study ID Numbers: hookey picosalax
Study First Received: December 8, 2006
Last Updated: November 2, 2009
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Bisacodyl
Sodium phosphate
Cathartics
 Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013