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

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ClinicalTrials.gov Identifier: NCT00410215
Recruitment Status : Completed
First Posted : December 12, 2006
Last Update Posted : September 22, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Lawrence Hookey, Queen's University

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.


Condition or disease Intervention/treatment Phase
Colonoscopy Drug: picosalax plus bisacodyl Drug: picosalax Drug: sodium phosphate Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 315 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing Picosalax and Oral Sodium Phosphate for Colon Cleansing Prior to Colonoscopy
Study Start Date : February 2006
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Ottawa Bowel Preparation scale [ Time Frame: At Colonoscopy. ]

Secondary Outcome Measures :
  1. Tolerance-Likert scale questionnaire [ Time Frame: After Preparation. ]
  2. Safety Hemodynamics, Blood Chemistry [ Time Frame: After Preparation. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Lawrence Hookey, Principal Investigator, Queen's University
ClinicalTrials.gov Identifier: NCT00410215     History of Changes
Other Study ID Numbers: hookey picosalax
First Posted: December 12, 2006    Key Record Dates
Last Update Posted: September 22, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Bisacodyl
Cathartics
Gastrointestinal Agents
Laxatives