Intravenous (IV) Methylnaltrexone (MNTX) in the Prevention of Post-Operative Ileus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2004-12-31

Brief Summary

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A double-blind, randomized, parallel-group study designed to evaluate the safety and activity of IV MNTX in the treatment of Post-Operative Ileus (POI) in patients who underwent segmental colectomies via laparotomy.

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Detailed Description

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Conditions

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Postoperative Ileus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

IV Methylnaltrexone (MNTX)

Intervention Type DRUG

Arm 2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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IV Methylnaltrexone (MNTX)

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Males and females, 18 yrs or older
2. Patients who have undergone a segmental colectomy
3. Must be receiving opioids via IV.

Exclusion Criteria

1. Patients who received any experimental drug in the last 30 days
2. Patients receiving spinal medication for post-operative pain relief
3. Patients who have undergone operations for complications related to inflammatory bowel disease
4. Patients with recent history of abdominal radiation therapy.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No