Study Evaluating Subcutaneous MOA-728 for the Treatment of Opioid-Induced Constipation (OIC) in Subjects With Chronic Non-Malignant Pain

Completed · Phase 3 · Has a placebo group

Conditions studied: Constipation

In brief

The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of subcutaneous MOA-728 versus placebo in subjects with chronic non-malignant pain who have Opioid-Induced Constipation (OIC).

Key facts

Study ID

NCT00529087

Run by

Bausch Health Americas, Inc.

People needed

460

Starts

2007-08-01

Expected to finish

2008-12-01

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 constipation and chronic non-malignant pain.
• 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 — Sun City, 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 — Garden Grove, California, United States
• Study site — Hawaiian Gardens, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Diego, California, United States
• Study site — Brandon, Florida, United States
• Study site — Cheifland, Florida, United States
• Study site — Clearwater, Florida, United States
• Study site — Gainesville, 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 — Naples, Florida, United States
• Study site — Ocala, Florida, United States
• Study site — Ocala, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Ormond Beach, Florida, United States
• Study site — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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