CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 158 enrolled
Drug / intervention
lubiprostone (Amitiza) +1 moredrug
Likely dose
lubiprostone (Amitiza) 24 mcgfrom 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/NCT00645801
NCT00645801Phase 4Completed

Lubiprostone Plus Polyethylene Glycol-electrolyte Solutionvs. Placebo Plus Polyethylene Glycol-electrolyte Solution for Outpatient Colonoscopy Preparation: A Randomized, Double-blind, Placebo-controlled Trial

Henry Ford Health System·interventional·Posted Mar 28, 2008·Updated Jun 1, 2023

In Brief

A Phase 4 clinical trial evaluating lubiprostone (Amitiza) and Placebo for Colonoscopy. Completed, enrolled 158 participants across 3 sites.

Detailed Summary

The primary objective is to compare the effectiveness and tolerance of the medication named lubiprostone plus a large volume liquid laxative versus placebo which is a look alike medication that has no effect such as a sugar pill plus a large volume liquid laxative as a bowel cleaning preparation for colonoscopy to see the colon better during the colonoscopy to identify abnormal growths such as polyps or colon cancer. Colonoscopy is considered the best way to screen for colon cancer screening because you can visualize the colon directly and remove or biopsy abnormal growths. The limiting step in the procedure is the quality of the colon preparation prior to the procedure. Many patients do not tolerate large volumes of liquid used to prepare the colon. The purpose of the study is to improve the quality of the prep by adding a pill laxative medication before starting the large volume laxative to better see the colon. The other aim of the study is to try to reduce the amount of of liquid laxative the patient has to drink by giving a pill laxative before starting the liquid laxative.

Study Details

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

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 28, 2008
Enrollment StartMar 1, 2008
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 18.3 years ago

Interventions

lubiprostone (Amitiza)drug

24 mcg administered 4 times over the two days before the colonoscopy. 96 mcg total

Placebodrug

Amitiza Placebo