A a Single Dose Efficacy Study in Inducing Laxation in Advance Illness Patients

• Status: Completed
• Trial end date: 2005-02-01
• Target enrollment: 0
• Participant gender: All

Summary

To test the effectiveness of MNTX in advanced illness subjects.

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

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Collaborator: Pfizer
• Treatments: Methylnaltrexone; Naltrexone

Criteria

Inclusion Criteria:

1. Advanced medical illness with a life expectancy of 1 to 6 months

2. No clinically significant laxation within 48 hours prior to the first dose of study drug

3. On stable opioid and laxative regimen for a least 3 days prior to treatment

4. Age greater than 18years

5. Females of child-bearing age must have a negative pregnancy test.

Exclusion Criteria:

1. Females who are pregnant or nursing.

2. Previous treatment with MNTX or prior treatment with naltrexone or naloxone for treatment of OIC

3. Any disease process suggestive of gastrointestinal obstruction

4. Fecal ostomy.