CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 425 enrolled
Drug / intervention
Miralax (PEG 3350) +3 moredrug
Likely dose
Amitiza (Lubiprostone) 24mcgfrom 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/NCT00953017
NCT00953017Phase 4Completed

A Randomized, Blinded Trial Comparing Miralax With Amitiza Pretreatment Versus Miralax With Dulcolax Pretreatment Versus Miralax Alone Without Pretreatment Versus Golytely for Bowel Cleansing Prior to Colonoscopy

Brooke Army Medical Center·interventional·Posted Aug 6, 2009·Updated Nov 30, 2012

In Brief

A Phase 4 clinical trial evaluating Miralax (PEG 3350), Amitiza (Lubiprostone), and 2 other interventions for Colonoscopy. Completed, enrolled 425 participants across 1 site.

Detailed Summary

Miralax (PEG 3350) has been shown to be a safe and uncomplicated bowel preparation prior to colonoscopy in pediatric populations. This study seeks to confirm the efficacy of this bowel cleansing regimen in adults and to determine the benefit of adding a pretreatment medication to this bowel preparation. The tolerability of Miralax will hopefully improve patient satisfaction with colonoscopy and decrease their reluctance to be screened because of the uncomfortable taste and side effects of bowel preparation regimens.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColonoscopy
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 6, 2009
Enrollment StartJul 1, 2009
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 16.9 years ago

Interventions

Miralax (PEG 3350)drug

Miralax 255gm bottle

Amitiza (Lubiprostone)drug

Amitiza 24mcg gelcap

Dulcolax (Bisacodyl)drug

Bisacodyl 5mg tab x2

Golytely (polyethylene glycol)drug

Golytely 1 gallon