Study Evaluating Oral MOA-728 for the Treatment of Opioid-Induced Bowel Dysfunction (OIBD) in Subjects With Chronic Non-Malignant Pain

Completed · Phase 2

Conditions studied: Constipation

In brief

The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of MOA-728 in subjects with Opioid-Induced Bowel Dysfunction (OIBD) with associated chronic non-malignant pain.

Key facts

Study ID

NCT00366431

Run by

Bausch Health Americas, Inc.

People needed

420

Starts

2006-08-01

Expected to finish

2007-03-01

Last updated by the study team

2019-11-25

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 non-malignant pain.
• Taking oral, transdermal, intravenous, or subcutaneous opioids.
• Willingness to discontinue all pre-study laxative therapy and utilize 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 — Birmingham, Alabama, United States
• Study site — Mobile, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Hot Springs, Arkansas, United States
• Study site — Anaheim, California, United States
• Study site — Anaheim, California, United States
• Study site — Bakersfield, California, United States
• Study site — Foothill Ranch, California, United States
• Study site — Garden Grove, California, United States
• Study site — Los Gatos, California, United States
• Study site — Orange, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — Trumbull, Connecticut, United States
• Study site — Hollywood, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Jupiter, Florida, United States
• Study site — Largo, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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