Status:
COMPLETED
Study Evaluating IV Methylnaltrexone for the Treatment of Post Operative Ileus
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Post Operative Bowel Dysfunction
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 th...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
End Date :
November 1 2007
Estimated Enrollment :
495 Patients enrolled
Trial Details
Trial ID
NCT00387309
Start Date
December 1 2006
End Date
November 1 2007
Last Update
November 25 2019
Active Locations (92)
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1
Mobile, Alabama, United States, 36617
2
Fort Smith, Arkansas, United States, 72901
3
Chula Vista, California, United States, 92114
4
Colton, California, United States, 92324