CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,040 enrolled
Drug / intervention
N-methylnaltrexone bromide (MOA-728)drug
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/NCT00804141
NCT00804141Phase 3Completed
CompareCT.gov

An Open-Label Study to Evaluate the Long-Term Safety of Subcutaneous MOA-728 for Treatment of Opioid-Induced Constipation in Subjects With Nonmalignant Pain

Bausch Health Americas, Inc.·interventional·Posted Dec 8, 2008·Updated Oct 18, 2019

In Brief

A Phase 3 clinical trial evaluating N-methylnaltrexone bromide (MOA-728) for Constipation. Completed, enrolled 1,040 participants across 120 sites in 6 countries.

Detailed Summary

This study is designed to evaluate the long-term safety and tolerability of the subcutaneous (SC) injection form of N-methylnaltrexone bromide (MOA-728) for the treatment of opioid-induced constipation in participants with nonmalignant pain. The study consists of a 2-week screening period, a 48-week open-label treatment period and a 2 week follow-up period. Participants will need to agree to self-administer SC injections, complete daily diaries, and check-in via a daily telephone call during the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsConstipation
CountriesAustralia, Canada, Colombia, South Korea, Spain, United States
CollaboratorsPfizer

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 8, 2008
Enrollment StartDec 3, 2008
Primary CompletionSep 20, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 17.6 years ago

Interventions

N-methylnaltrexone bromide (MOA-728)drug

MOA-728 will be administered as per the dose and schedule specified in the arm.