Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00410215
Status:
COMPLETED
Last Update Posted:
2015-09-22
First Post:
2006-12-08
Brief Title:
A Randomized Controlled Trial Comparing Picosalax and Oral Sodium Phosphate for Colon Cleansing Prior to Colonoscopy
Sponsor:
Queens University
Organization:
Queens University
Study Overview
Official Title:
A Randomized Controlled Trial Comparing Picosalax and Oral Sodium Phosphate for Colon Cleansing Prior to Colonoscopy
Status:
COMPLETED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None