A Randomized Controlled Trial Comparing Two Timing Regimens of Pico-salax for Colon Cleansing Prior to Colonoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lawrence Hookey, Queen's University
ClinicalTrials.gov Identifier:
NCT00885274
First received: April 20, 2009
Last updated: September 14, 2011
Last verified: September 2011
  Purpose

Pico-Salax is an osmotic and stimulant bowel cleansing agent used prior to colonoscopy. It is unknown whether splitting the doses (i.e. taking the second dose the morning of the colonoscopy) results in a better bowel cleansing, as research with other agents suggests this may be the case. This study aims to assess whether splitting the dose of Pico-Salax results in a better bowel cleansing than traditional dosing.


Condition Intervention Phase
Colonoscopy
Drug: Pico-Salax
Drug: Split Dose Pico-Salax
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Randomized Controlled Trial Comparing Two Timing Regimens of Pico-salax for Colon Cleansing Prior to Colonoscopy.

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • bowel cleansing assessed by the Ottawa Bowel Preparation Scale [ Time Frame: day of colonoscopy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • patient tolerance of preparation [ Time Frame: day of colonoscopy ] [ Designated as safety issue: No ]

Enrollment: 250
Study Start Date: November 2008
Study Completion Date: August 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Split Dose
Doses of Pico-Salax split: one dose administered the night prior to colonoscopy and the other dose administered the day of the procedure.
Drug: Split Dose Pico-Salax
One dose of Pico-Salax taken the evening prior to colonoscopy and the other the morning of the procedure.
Active Comparator: Traditional Dose
Both doses of Pico-Salax taken the evening prior to colonoscopy.
Drug: Pico-Salax
Both doses of Pico-Salax taken the evening prior to colonoscopy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • colonoscopy indicated

Exclusion Criteria:

  • congestive heart failure
  • ascites
  • renal failure
  • hyponatremia
  • previous intestinal surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00885274

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

No publications provided by Queen's University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lawrence Hookey, Assistant professor of Medicine, Queen's University
ClinicalTrials.gov Identifier: NCT00885274     History of Changes
Other Study ID Numbers: Hookey Pico-Salax Timing
Study First Received: April 20, 2009
Last Updated: September 14, 2011
Health Authority: Canada: Health Canada

ClinicalTrials.gov processed this record on August 28, 2014