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

• Status: Completed
• Trial end date: 2010-09-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Collaborator: Pfizer
• Treatments: Analgesics, Opioid; Bromides; Methylnaltrexone; Naltrexone

Criteria

Inclusion Criteria:

• Men and women 18 years or older.

• A history of pain of at least 2 months duration before the screening visit due to documented underlying nonmalignant condition.

• A history of constipation due to opioid use during 1 month before the screening visit.

Exclusion Criteria:

• A diagnosis of significant gastrointestinal (GI) disorder such as bowel obstruction, fecal incontinence or rectal prolapse.

• A history of active inflammatory bowel disease, irritable bowel syndrome, or megacolon within 6 months before the screening visit.

• A history of malignancy, other than basal cell or squamous cell skin carcinoma, within 5 years before the screening visit.

• A history of chronic constipation before initiation of opioid therapy.