Intravenous (IV) Methylnaltrexone (MNTX) in the Prevention of Post-Operative Ileus

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A double-blind, randomized, parallel-group study designed to evaluate the safety and activity of IV MNTX in the treatment of Post-Operative Ileus (POI) in patients who underwent segmental colectomies via laparotomy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

1. Males and females, 18 yrs or older

2. Patients who have undergone a segmental colectomy

3. Must be receiving opioids via IV.

Exclusion Criteria:

1. Patients who received any experimental drug in the last 30 days

2. Patients receiving spinal medication for post-operative pain relief

3. Patients who have undergone operations for complications related to inflammatory bowel disease

4. Patients with recent history of abdominal radiation therapy.