At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 804 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 Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Oral Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Subjects With Chronic, Non-Malignant Pain
In Brief
A Phase 3 clinical trial evaluating Methylnaltrexone and Placebo for Opioid-Induced Constipation. Completed, enrolled 804 participants across 2 sites.
Detailed Summary
MNTX 3201 is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral MNTX for the treatment of opioid induced constipation in participants with chronic, non-malignant pain.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid-Induced Constipation
CountriesUnited States
CollaboratorsProgenics Pharmaceuticals, Inc.
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2010
Enrollment StartSep 2010
Primary CompletionSep 2011
TodayJul 2026
First PostedAug 23, 2010
Enrollment StartSep 1, 2010
Primary CompletionSep 8, 2011
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 15.9 years ago
Interventions
Methylnaltrexonedrug
Methylnaltrexone will be administered as per the dose and schedule specified in the respective arms.
Placebodrug
Placebo matching to methylnaltrexone will be administered as per the schedule specified in the respective arms.