Overview

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.