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

Bausch Health

Status and phase: Completed; Phase 2

Conditions: Constipation

Treatments: Drug: MOA-728

Study type: Interventional

Funder types: Industry

Identifiers

NCT00366431

3200A3-200

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind