Study of Methylnaltrexone (MNTX) for the Relief of Constipation

A Double-Blind, Phase 3, Two-Week, Placebo Controlled Study of Methylnaltrexone(MNTX) for the Relief of Constipation Due to Opioid Therapy in Advance Medical Illness.

To determine the efficacy of subcutaneous MNTX to relieve opioid-induced constipation in patients with advanced medical illness.

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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