At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 156 enrolled
Drug / intervention
Methylnaltrexone bromidedrug
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.
Open-Label Extension Study To Assess The Safety Of A Fixed Dose Of Subcutaneous Methylnaltrexone In Subjects With Advanced Illness And Opioid-Induced Constipation
In Brief
A Phase 4 clinical trial evaluating Methylnaltrexone bromide for Opioid-Induced Constipation. Completed, enrolled 156 participants across 46 sites in 10 countries.
Detailed Summary
This is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the safety of methylnaltrexone. This drug will be administered by subcutaneous injection and will be tested in late stage, advanced illness patients who have constipation caused by opioid pain relievers. This study will last 3 months.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid-Induced Constipation
CountriesAustralia, Belgium, Canada, France, Germany, Italy, Mexico, Portugal, United Kingdom, United States
CollaboratorsProgenics Pharmaceuticals, Inc.
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 2008
Enrollment StartJul 2008
Primary CompletionJan 2013
Study CompletionMay 2013
TodayJul 2026
First PostedMay 6, 2008
Enrollment StartJul 1, 2008
Primary CompletionJan 1, 2013
Study CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 18.2 years ago
Interventions
Methylnaltrexone bromidedrug