At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 460 enrolled
Drug / intervention
N-methylnaltrexone bromide (MOA-728) +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 Mulitcenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Subcutaneous MOA-728 for the Treatment of Opioid-Induced Constipation in Subjects With Chronic Non-Malignant Pain
In Brief
A Phase 3 clinical trial evaluating N-methylnaltrexone bromide (MOA-728) and placebo for Constipation. Completed, enrolled 460 participants across 78 sites.
Detailed Summary
The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of subcutaneous MOA-728 versus placebo in subjects with chronic non-malignant pain who have Opioid-Induced Constipation (OIC).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsConstipation
CountriesUnited States
CollaboratorsProgenics Pharmaceuticals, Inc.
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2007
First PostedSep 2007
Primary CompletionDec 2008
TodayJul 2026
First PostedSep 14, 2007
Enrollment StartAug 1, 2007
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 18.8 years ago
Interventions
N-methylnaltrexone bromide (MOA-728)drug
Subcutaneous
placeboother
placebo