CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 2,154 enrolled
Drug / intervention
Polyethylene glycol +1 moredrug
Likely dose
Oral sodium phosphate solution 48 gfrom 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/NCT01427296
NCT01427296Phase 4Completed

A Phase 4, Randomized, Active Comparator, Open-Label, Multicenter Study to Assess the Safety and Efficacy of OsmoPrep® Tablets Versus HalfLytely® and Bisacodyl Tablet Bowel Prep Kit for Colon Cleansing

Bausch Health Americas, Inc.·interventional·Posted Sep 1, 2011·Updated Jan 18, 2018

In Brief

A Phase 4 clinical trial evaluating Polyethylene glycol and Oral sodium phosphate solution for Colon Cleansing. Completed, enrolled 2,154 participants across 18 sites.

Detailed Summary

The purpose of this study is to compare the safety and efficacy of OsmoPrep tablets versus HalfLytely and Bisacodyl Tablet Bowel Prep Kit in subjects who are undergoing colonoscopy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColon Cleansing
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 1, 2011
Enrollment StartSep 16, 2011
Primary CompletionMar 11, 2014
Study CompletionDec 9, 2014
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 14.8 years ago

Interventions

Polyethylene glycoldrug

HalfLytely and Bisacodyl Tablet Bowel Prep Kit, administered as 1 bisacodyl tablet followed by HalfLytely oral solution in a total liquid volume of approximately 2 L

Oral sodium phosphate solutiondrug

OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L