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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

524 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2008-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Post-Operative Ileus (POI)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MNTX 12 mg

Participants will receive methylnaltrexone (MNTX) 12 milligrams (mg) as an intravenous (IV) infusion over approximately 20 minutes for every 6 hours until one of the following occurs: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug will be administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple is placed in the participant).

Group Type EXPERIMENTAL

Methylnaltrexone

Intervention Type DRUG

Methylnaltrexone will be administered as per the dose and schedule specified in the respective arms.

MNTX 24 mg

Participants will receive MNTX 24 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurs: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug will be administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple is placed in the participant).

Group Type EXPERIMENTAL

Methylnaltrexone

Intervention Type DRUG

Methylnaltrexone will be administered as per the dose and schedule specified in the respective arms.

Placebo

Participants will receive placebo matching to MNTX as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurs: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug will be administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple is placed in the participant).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo matching to methylnaltrexone will be administered as per the schedule specified in the respective arm.

Interventions

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Methylnaltrexone

Methylnaltrexone will be administered as per the dose and schedule specified in the respective arms.

Intervention Type DRUG

Placebo

Placebo matching to methylnaltrexone will be administered as per the schedule specified in the respective arm.

Intervention Type DRUG

Other Intervention Names

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MNTX

Eligibility Criteria

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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.