Study of Methylnaltrexone (MNTX) for the Relief of Constipation
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To determine the efficacy of subcutaneous MNTX to relieve opioid-induced constipation in patients with advanced medical illness.
Condition or disease
Advance Illness Patients With OIC
Drug: SC MethylnaltrexoneDrug: SC Placebo
This is a multi-center, double-blind, randomized parallel group study conducted in patients with advanced medical illness and opioid-induced constipation. Eligible patients are randomly assigned to receive SC doses of either MNTX, dose 1 or placebo every other day for 2 weeks. At Day 8, eligible patients, if allowed, could be escalated to a a higher dose of MNTX.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
18 years of age and older
Negative pregnancy test (serum or urine) at screening for all women of childbearing potential
Advanced Medical Illness (i.e., terminal illness, such as incurable cancer or end of stage AIDS) with life expectancy of ≥ 1 month
patient must sign ICF
Women who are pregnant and/or nursing
Previous treatment with MNTX
Participation in any other studies involving investigational products within 30 days prior to screening