Status:
COMPLETED
Study of Methylnaltrexone (MNTX) for the Relief of Constipation
Lead Sponsor:
Bausch Health Americas, Inc.
Collaborating Sponsors:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Advance Illness Patients With OIC
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 re...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT00402038
Start Date
February 1 2004
End Date
October 1 2005
Last Update
November 25 2019
Active Locations (1)
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1
Progenics Pharmaceuticals, Inc.
Tarrytown, New York, United States, 10591