CompletedPhase 3

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

United States524 participantsStarted 2006-10-31

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Time to First Bowel Movement

Timeframe: Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10

Trial details

NCT IDNCT00401375

SponsorBausch Health Americas, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-02-29

Results submitted2019-08-12

View on ClinicalTrials.gov More Post-Operative Ileus (POI) trials