Study of Intravenous (IV) Methylnaltrexone Bromide (MNTX) in the Treatment of Post-Operative Ileus (POI)

• Status: Completed
• Trial end date: 2008-02-29
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and efficacy of MNTX in participants 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.

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

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Collaborator: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Bromides; Methylnaltrexone; Naltrexone

Criteria

Inclusion Criteria:

• Male and female participants at least 18 years of age.

• All participants must meet American Society of Anesthesiologists (ASA) physical status I, II, or III.

• Participants must sign an informed consent form (ICF).

• Participants must be scheduled for a segmental colectomy via open laparotomy with general anesthesia.

• Females of childbearing potential must have a negative serum pregnancy test at the screening visit.

• Negative for history of chronic active hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV) infection.

Exclusion Criteria:

• Participants who received any investigational new drug in the 30 days prior to screening visit.

• Females who are pregnant or lactating.