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

Completed · Phase 3 · Has a placebo group

Conditions studied: Post-Operative Ileus (POI)

In brief

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.

Key facts

Study ID

NCT00401375

Run by

Bausch Health Americas, Inc.

People needed

524

Starts

2006-10-31

Expected to finish

2008-02-29

Last updated by the study team

2019-09-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Participants who received any investigational new drug in the 30 days prior to screening visit.
• Females who are pregnant or lactating.

Where it is running

• Progenics Pharmaceuticals — Tarrytown, New York, United States

Full record on ClinicalTrials.gov

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