Post Operative Bowel Dysfunction
Conditions
Keywords
Bowel
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 than with a placebo regimen.
Interventions
DRUGMethylnaltrexone (MOA-728)
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 MOA-728 regimen than with a placebo regimen. | — |
Countries
Australia, Germany, Hungary, Italy, Poland, Romania, Serbia and Montenegro, South Africa, South Korea, United States
Outcome results
None listed