Study Evaluating IV Methylnaltrexone for the Treatment of Post Operative Ileus

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective: In subjects who have undergone segmental colectomy, the time between the end of surgery and first bowel movement is significantly shorter with the investigational MOA-728 regimen than with a placebo regimen.

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

Details

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

Criteria

Inclusion:

• Must be scheduled for a segmental colectomy via open laparotomy with general anesthesia

• Subjects with history of inflammatory bowel disease are eligible as long as the disease is not currently active and all other criteria are met

• Subjects must meet the American Society of Anesthesiologists physical status I, II or III

Exclusion:

• Subjects who are scheduled for laparoscopic surgery for the segmental colectomy

• Subjects with a recent history (<1 year prior to randomization) of abdominal radiation therapy; Subjects with a history of small bowel obstruction, known or suspected bowel adhesions (other than minor, clinically nonsignificant adhesions)

• Subjects undergoing operations resulting in gastrointestinal ostomies, or who require use of post operative nonsteroidal anti-inflammatory drugs (NSAIDs)