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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00885274
First Posted: April 21, 2009
Last Update Posted: August 31, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Lawrence Hookey, Queen's University
  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
Intervention Model: Parallel Assignment
Masking: Double (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 Dr. Lawrence Hookey, Queen's University:

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

Secondary Outcome Measures:
  • patient tolerance of preparation [ Time Frame: day of colonoscopy ]

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

Information from the National Library of Medicine

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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:

  • colonoscopy indicated

Exclusion Criteria:

  • congestive heart failure
  • ascites
  • renal failure
  • hyponatremia
  • previous intestinal surgery
  Contacts and Locations
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): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Lawrence Hookey, Assistant professor of Medicine, Queen's University
ClinicalTrials.gov Identifier: NCT00885274     History of Changes
Other Study ID Numbers: Hookey Pico-Salax Timing
First Submitted: April 20, 2009
First Posted: April 21, 2009
Last Update Posted: August 31, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Magnesium Oxide
Citric Acid
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents