CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 122 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.

Search/NCT00547586
NCT00547586Phase 2Completed
CompareCT.gov

A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study of Oral MOA-728 for the Treatment of Opioid- Induced Bowel Dysfunction in Subjects With Chronic Nonmalignant Pain

Bausch Health Americas, Inc.·interventional·Posted Oct 22, 2007·Updated Aug 20, 2020

In Brief

A Phase 2 clinical trial evaluating N-methylnaltrexone bromide (MOA-728) and placebo for Constipation. Completed, enrolled 122 participants across 41 sites.

Detailed Summary

The primary purpose of this study is to evaluate the safety and dose-response relationship of N-methylnaltrexone bromide (MOA-728) by observing spontaneous bowel movements in subjects with chronic pain, which is not due to malignant cancer, and who have opioid-induced bowel dysfunction (OIBD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsConstipation
CountriesUnited States
CollaboratorsProgenics Pharmaceuticals, Inc.

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 22, 2007
Enrollment StartOct 1, 2007
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 18.7 years ago

Interventions

N-methylnaltrexone bromide (MOA-728)drug

Oral

placeboother

placebo