Study Evaluating the Efficacy and Safety of Subcutaneous Methylnaltrexone (MOA-728) for the Treatment of Opioid-Induced-Constipation

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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 adult Asian subjects with opioid-induced constipation associated with advanced illness (ie, a terminal illness such as incurable cancer or other end-stage disease) or chronic nonmalignant pain.

• 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; Methylnaltrexone

Criteria

Inclusion Criteria:

• Men and women who are at least 18 years of age, and who have a diagnosis of advanced illness with anticipated life expectancy >= 1 month;

• Is receiving a regular dose of opioids for the control of pain;

• Has a diagnosis of opioid induced constipation;

• Is on a stable laxative regimen.

Exclusion Criteria:

• Has a known or suspected mechanical gastrointestinal obstruction, or any potential non-opioid cause of bowel dysfunction contributed to constipation;

• Has evidence of current fecal impaction;

• Has evidence of active diverticulitis, or peritonitis, or a history of bowel surgery within 30 days before test article administration;

• Has a body weight less than 27 kg

• Has any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study, or could preclude the evaluation of the subject's response.