Methylnaltrexone in Patients With Opioid-Induced Bowel Dysfunction

Completed · Phase 2

Conditions studied: Bowel Dysfunction

In brief

This is a double-blind, randomized, parallel group, dose ranging study of subcutaneous methylnaltrexone to be conducted in patients with advanced medical illness and poorly controlled opioid induced constipation. Patients will be randomized to one of three fixed dose levels of SC MNTX.

Key facts

Study ID

NCT01367574

Run by

Bausch Health Americas, Inc.

People needed

39

Starts

2002-04-01

Expected to finish

2003-05-01

Last updated by the study team

2019-11-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must have advanced medical illness (cancer, HIV, etc) and be receiving palliative care
• Must be on opioid medication for at least 2 weeks with no expectation of significant change in regimen
• Must have constipation
• Must be 18 yrs or older

You may not qualify if…

• Concurrent use of medications other than opioids which might interfere with gastrointestinal motility
• Patients who received any experimental drug in the last 30 days
• Patients with active peritoneal cancer (ovarian, etc.)
• Patients with active diverticulitis or diverticulosis

Where it is running

• Progenics Pharmaceuticals, Inc. — Tarrytown, New York, United States

Full record on ClinicalTrials.gov

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