Clinical Trial: Study Evaluating The Efficacy And Safety Of Subcutaneous MOA-728 For The Treatment Of Opioid-Induced-Constipation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, And Parallel-Group Study Of Subcutaneous MOA-728 For The Treatment Of Opioid-Induced Constipation In Adult Sub

Brief Summary: The primary purpose of this study is to evaluate the safety, efficacy, and tolerability of subcutaneous (injection beneath the skin) MOA-728 versus placebo in Asian Adult subjects with opioid-induced constipation and advanced illness

Detailed Summary:
Sponsor: Valeant Pharmaceuticals International, Inc.

Current Primary Outcome: The proportion of subjects having a rescue-free bowel movement (RFBM) within 4 hours after the first injection, and after each dose during DB period. [ Time Frame: 2 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Percentage of injection resulting in RFBM within 4 hours after test article administration. [ Time Frame: 2 weeks ]

Original Secondary Outcome: Same as current

Information By: Valeant Pharmaceuticals International, Inc.

Dates:
Date Received: July 8, 2009
Date Started: July 2009
Date Completion:
Last Updated: November 7, 2013
Last Verified: November 2013