At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 237 enrolled
Drug / intervention
Methylnaltrexone +1 moredrug
Likely dose
Not stated in 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.
A Randomized, Double-Blind, Placebo-Controlled Study Of A Fixed Dose Of Subcutaneous Methylnaltrexone In Adults With Advanced Illness And Opioid-Induced Constipation: Efficacy, Safety, And Additional Health Outcomes
In Brief
A Phase 4 clinical trial evaluating Methylnaltrexone and Placebo for Opioid-Induced Constipation. Completed, enrolled 237 participants across 60 sites in 12 countries.
Detailed Summary
This study will evaluate the safety and efficacy of methylnaltrexone administered as subcutaneous injections in subjects who have opioid-induced constipation and an advanced illness. The hypothesis is that methylnaltrexone will be safe and effective in relieving opioid-induced constipation in these subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid-Induced Constipation
CountriesAustralia, Belgium, Brazil, Canada, France, Germany, Italy, Mexico, Spain, Sweden, United Kingdom, United States
CollaboratorsProgenics Pharmaceuticals, Inc.
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 2008
Enrollment StartJun 2008
Primary CompletionFeb 2013
TodayJul 2026
First PostedMay 6, 2008
Enrollment StartJun 1, 2008
Primary CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 18.2 years ago
Interventions
Methylnaltrexonedrug
Placebodrug