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

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.