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

Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00885274
• Other study ID #: Hookey Pico-Salax Timing
• Status: Completed
• Phase: Phase 4
• First received: April 20, 2009
• Last updated: August 27, 2015
• Start date: November 2008
• Est. completion date: August 2011

Study information

• Verified date: August 2015
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: August 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• colonoscopy indicated

Exclusion Criteria:

• congestive heart failure

• ascites

• renal failure

• hyponatremia

• previous intestinal surgery

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Drug:
• Pico-Salax
Both doses of Pico-Salax taken the evening prior to colonoscopy
• Split Dose Pico-Salax
One dose of Pico-Salax taken the evening prior to colonoscopy and the other the morning of the procedure.

Locations

Country	Name	City	State
Canada	Hotel Dieu Hospital	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bowel cleansing assessed by the Ottawa Bowel Preparation Scale		day of colonoscopy	Yes
Secondary	patient tolerance of preparation		day of colonoscopy	No