CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 78 enrolled
Drug / intervention
LUBIPROSTONEdrug
Likely dose
LUBIPROSTONE 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/NCT00908076
NCT00908076Phase 4Completed
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Randomized Double-Blind Placebo-Controlled Trial of Lubiprostone in the Treatment of Constipation Associated With Parkinson's Disease

Baylor College of Medicine·interventional·Posted May 25, 2009·Updated Dec 29, 2022

In Brief

A Phase 4 clinical trial evaluating LUBIPROSTONE for Parkinson's Disease. Completed, enrolled 78 participants across 2 sites.

Detailed Summary

The purpose of this study is to determine if Amitiza (lubiprostone), a drug proven to be safe and effective for chronic constipation, will also improve constipation symptoms in Parkinson's Disease patients. We will also evaluate the impact of the drug on changes in bowel movement consistency, quality of life and motor symptoms.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease
CountriesUnited States
CollaboratorsUniversity of South Florida

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 25, 2009
Enrollment StartFeb 1, 2009
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 17.1 years ago

Interventions

LUBIPROSTONEdrug

Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.