Methylnaltrexone in Patients With Opioid-Induced Bowel Dysfunction
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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.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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