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

Completed · Phase 3

Conditions studied: Constipation

In brief

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.

Key facts

Study ID

NCT00804141

Run by

Bausch Health Americas, Inc.

People needed

1040

Starts

2008-12-03

Expected to finish

2010-09-20

Last updated by the study team

2019-10-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — Chandler, Arizona, United States
• Pfizer Investigational Site — Mesa, Arizona, United States
• Pfizer Investigational Site — Mesa, Arizona, United States
• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Tempe, Arizona, United States
• Pfizer Investigational Site — Tucson, Arizona, United States
• Pfizer Investigational Site — Tucson, Arizona, United States
• Pfizer Investigational Site — Hot Springs, Arkansas, United States
• Pfizer Investigational Site — Garden Grove, California, United States
• Pfizer Investigational Site — Laguna Hills, California, United States
• Pfizer Investigational Site — Los Gatos, California, United States
• Pfizer Investigational Site — Newport Beach, California, United States
• Pfizer Investigational Site — Newport Beach, California, United States
• Pfizer Investigational Site — Colorado Springs, Colorado, United States
• Pfizer Investigational Site — Boca Raton, Florida, United States
• Pfizer Investigational Site — Brandon, Florida, United States
• Pfizer Investigational Site — Chiefland, Florida, United States
• Pfizer Investigational Site — Clearwater, Florida, United States
• Pfizer Investigational Site — Daytona Beach, Florida, United States
• Pfizer Investigational Site — Fort Myers, Florida, United States
• Pfizer Investigational Site — Gainesville, Florida, United States
• Pfizer Investigational Site — Jacksonville, Florida, United States
• Pfizer Investigational Site — Jacksonville, Florida, United States
• Pfizer Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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