NCT00804141

Study Evaluating Long-Term Safety of MOA-728 in Participants With Opioid-Induced Constipation

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,040 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Constipation

Interventions

Type	Name	Description
DRUG	N-methylnaltrexone bromide (MOA-728)	MOA-728 will be administered as per the dose and schedule specified in the arm.

Timeline

• Start date: 2008-12-03
• Primary completion: 2010-09-20
• Completion: 2010-09-20
• First posted: 2008-12-08
• Last updated: 2019-10-18
• Results posted: 2019-10-18

Locations

120 sites across 6 countries: United States, Australia, Canada, Colombia, South Korea, Spain