At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 37 enrolled
Drug / intervention
Methylnaltrexone bromide +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 Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo Controlled Phase 2 Study of Once-Daily Subcutaneous Methylnaltrexone (MNTX) in the Treatment of Opioid-Induced Constipation During Rehabilitation After Orthopedic Procedures
In Brief
A Phase 2 clinical trial evaluating Methylnaltrexone bromide and Placebo for Opioid-induced Constipation. Completed, enrolled 37 participants across 1 site.
Detailed Summary
The purpose of this study is to examine the safety and activity of MNTX in relieving opioid-induced constipation following orthopedic procedures.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid-induced Constipation
CountriesUnited States
CollaboratorsWyeth is now a wholly owned subsidiary of Pfizer
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2007
First PostedMar 2008
Primary CompletionJan 2009
TodayJul 2026
First PostedMar 21, 2008
Enrollment StartOct 19, 2007
Primary CompletionJan 21, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.3 years ago
Interventions
Methylnaltrexone bromidedrug
Methylnaltrexone will be administered as per the dose and schedule specified in the respective arm.
Placebodrug
Placebo matching to methylnaltrexone will be administered as per the dose and schedule specified in the respective arm.