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

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• 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.

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.