Study Evaluating Oral MOA-728 For The Treatment Of OIBD In Subjects With Chronic Non-Malignant Pain

Completed · Phase 2 · Has a placebo group

Conditions studied: Constipation

In brief

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).

Key facts

Study ID

NCT00547586

Run by

Bausch Health Americas, Inc.

People needed

122

Starts

2007-10-01

Expected to finish

2008-02-01

Last updated by the study team

2020-08-20

Who can join

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

You may qualify if…

• Adult outpatients with opioid-induced bowel dysfunction and chronic pain, which is not due to malignant cancer.
• Taking oral, transdermal, intravenous, or subcutaneous opioids.
• Willingness to discontinue all pre-study laxative therapy and use only study permitted rescue laxatives.

You may not qualify if…

• History of chronic constipation before the initiation of opioid therapy.
• Other GI disorders known to affect bowel transit.
• Women who are pregnant, breast-feeding, or plan to become pregnant.

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Litchfield Park, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Hot Springs, Arkansas, United States
• Study site — Hot Springs, Arkansas, United States
• Study site — Garden Grove, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Murrieta, California, United States
• Study site — San Diego, California, United States
• Study site — Chiefland, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Jupiter, Florida, United States
• Study site — Largo, Florida, United States
• Study site — Naples, Florida, United States
• Study site — Ocala, Florida, United States
• Study site — Ormond Beach, Florida, United States
• Study site — Spring Hill, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Sunset, Louisiana, United States
• Study site — Elkridge, Maryland, United States
• Study site — Brockton, Massachusetts, United States
• Study site — Cadillac, Michigan, United States

Full record on ClinicalTrials.gov

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