Study Evaluating IV Methylnaltrexone for the Treatment of Post Operative Ileus

Bausch Health

Status and phase

Completed

Phase 3

Conditions

Post Operative Bowel Dysfunction

Treatments

Drug: Methylnaltrexone (MOA-728)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00387309

3200L2-300

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)