Study of Methylnaltrexone (MNTX) for the Relief of Constipation
- Conditions
- Advance Illness Patients With OIC
- Interventions
- Drug: SC Placebo
- Registration Number
- NCT00402038
- Lead Sponsor
- Bausch Health Americas, Inc.
- Brief Summary
To determine the efficacy of subcutaneous MNTX to relieve opioid-induced constipation in patients with advanced medical illness.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 134
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 SC Methylnaltrexone - Arm 2 SC Placebo -
- Primary Outcome Measures
Name Time Method Laxation within four hours of a single dose of SC MNTX and efficacy of SC MNTX every other day over a 1 week period. 2 weeks To determine the efficacy of a single dose of SC MNTX compared with placebo in inducing laxation within 4 hours.
To determine the efficacy of SC MNTX every other day over a 1-week treatment period in relieving OIC in patients with AMI.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Progenics Pharmaceuticals, Inc.
🇺🇸Tarrytown, New York, United States