CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 3,476 enrolled
Drug / intervention
High volume PEG split-dose +7 moredrug
Likely dose
High volume PEG split-dose 240 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02547571
NCT02547571Phase 4Completed

The Bowel CLEAnsing: A National Initiative

Alan Barkun·interventional·Posted Sep 11, 2015·Updated Sep 13, 2018

In Brief

A Phase 4 clinical trial evaluating High volume PEG split-dose, Low volume PEG split-dose, and 6 other interventions for Subjets Requiring a Colonoscopy. Completed, enrolled 3,476 participants across 10 sites.

Detailed Summary

The purpose of this study is to compare diet, type of bowel preparation and time of colonoscopy to determine if one method is better than the other and, if they are the same, identify the one which is the most convenient for the patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
CollaboratorsPendopharm

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 11, 2015
Enrollment StartMar 1, 2016
Primary CompletionSep 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 10.8 years ago

Interventions

High volume PEG split-dosedrug

Colyte® or PegLyte® will be provided to the subject who will be asked to drink 2L of the preparation starting at 7:00 PM the day before the procedure at a rate of 240 mL every 10 minutes until completed. The second dose of 2L of preparation will be taken the morning of the colonoscopy starting 4-5 hours prior to the planned procedural time at a rate of 240 mL every 10 minutes until completed.

Low volume PEG split-dosedrug

Bi-PegLyte® will be provided to the subject who will be asked to ingest 3 tabs of Bisacodyl 5 mg (total 15 mg) at 2:00 PM the day before the procedure. After the first bowel movement, or if there is no bowel movement within 6 hours of taking the Bisacodyl tablets, the subject will be asked to drink 1L of the solution at a rate of 240 mL every 10 minutes until the solution is completed. The second dose of 1L of preparation will be taken the morning of the colonoscopy starting 4-5 hours prior to the procedure at a rate of 240 mL every 10 minutes. Use of antacids will not be permitted within one hour of taking bisacodyl.

High volume PEG non split, day beforedrug

Colyte® or PegLyte® will be provided to the subject who will be asked to drink 4L of preparation starting at 6:00 PM the day before the procedure, at a rate of 240 mL every 10 minutes until completed.

Low volume PEG non split, same daydrug

Bi-PegLyte® will be provided to the subject, who will be asked to ingest 3 tabs of Bisacodyl 5 mg (total 15 mg) at 2:00 PM the day before the procedure and will drink 2L of preparation the morning of the colonoscopy starting 4 hours prior to the procedure at a rate of 240 mL every 10 minutes, until completed. Use of antacids will not be permitted within one hour of taking Bisacodyl.

Clear liquid dietother

Low residue dietother

Early colonoscopy (stratified)other

"Early" appointments: 7:30 AM to 10h30 AM

Later colonoscopy (stratified)other

"Later" appointments: 10:30 AM to 4:30 PM.