Study of Intravenous (IV) Methylnaltrexone Bromide (MNTX) in the Treatment of Post-Operative Ileus (POI).
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To evaluate the safety and efficacy of MNTX in patients who have undergone segmental colectomy and to assess if the time between the end of surgery and the first bowel movement is significantly shorter in the MNTX regimen than the equivalent assessment using a placebo regimen.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Selected Inclusion Criteria:
Male and female patients at least 18 years of age
Patients must meet ASA physical status I, II, or III
Patient must sign an ICF
Patients must be scheduled for a segmental colectomy
Females of childbearing potential must have a negative serum pregnancy test at the screening visit
Negative for history of chronic active hepatitis B, HCV or HIV infection
Selected Exclusion Criteria:
Patients who received any investigational new drug in the previous 30 days