Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety and efficacy of methylnaltrexone administered as subcutaneous injections in subjects who have opioid-induced constipation and an advanced illness. The hypothesis is that methylnaltrexone will be safe and effective in relieving opioid-induced constipation in these subjects.

• Phase: Phase 4
• 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:

• Is an adult 18 years of age or older

• Has a diagnosis of advanced illness (ie, a terminal illness such as incurable cancer or other end-stage disease)

• Has a life expectancy of at least 1 month.

• Is receiving opioids on a regular schedule (not just as-needed or rescue doses) for the control of pain or discomfort for at least 2 weeks before the first dose of study drug.

• Has constipation that is caused by opioid medications.

Exclusion Criteria:

• Has a known or suspected allergy to methylnaltrexone or other similar compounds (e.g. naltrexone or naloxone).

• Has a known or suspected mechanical gastrointestinal obstruction.

• Has any potential nonopioid cause of bowel dysfunction that might be a major contributor to the constipation.

• Has any other clinically important abnormalities as determined by the investigator that may interfere with his or her participation in or compliance with the study.

• Receiving opioid antagonist or partial antagonist products.