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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:
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
History of Changes

April 20, 2009
September 14, 2011
November 2008
March 2011   (final data collection date for primary outcome measure)
bowel cleansing assessed by the Ottawa Bowel Preparation Scale [ Time Frame: day of colonoscopy ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00885274 on ClinicalTrials.gov Archive Site
patient tolerance of preparation [ Time Frame: day of colonoscopy ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Randomized Controlled Trial Comparing Two Timing Regimens of Pico-salax for Colon Cleansing Prior to Colonoscopy
A Randomized Controlled Trial Comparing Two Timing Regimens of Pico-salax for Colon Cleansing Prior to Colonoscopy.

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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Colonoscopy
  • Drug: Pico-Salax
    Both doses of Pico-Salax taken the evening prior to colonoscopy
  • Drug: Split Dose Pico-Salax
    One dose of Pico-Salax taken the evening prior to colonoscopy and the other the morning of the procedure.
  • 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.
    Intervention: Drug: Split Dose Pico-Salax
  • Active Comparator: Traditional Dose
    Both doses of Pico-Salax taken the evening prior to colonoscopy.
    Intervention: Drug: Pico-Salax
Flemming JA, Vanner SJ, Hookey LC. Split-dose picosulfate, magnesium oxide, and citric acid solution markedly enhances colon cleansing before colonoscopy: a randomized, controlled trial. Gastrointest Endosc. 2012 Mar;75(3):537-44. Epub 2011 Dec 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
August 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • colonoscopy indicated

Exclusion Criteria:

  • congestive heart failure
  • ascites
  • renal failure
  • hyponatremia
  • previous intestinal surgery
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00885274
Hookey Pico-Salax Timing
No
Lawrence Hookey, Queen's University
Queen's University
Not Provided
Principal Investigator: Lawrence Hookey, MD Queen's University
Queen's University
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP