Study of Methylnaltrexone (MNTX) for the Relief of Constipation

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Collaborator: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Methylnaltrexone; Naltrexone

Criteria

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