Methylnaltrexone in Patients With Opioid-Induced Bowel Dysfunction

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

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2003-05-31

Brief Summary

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This is a double-blind, randomized, parallel group, dose ranging study of subcutaneous methylnaltrexone to be conducted in patients with advanced medical illness and poorly controlled opioid induced constipation. Patients will be randomized to one of three fixed dose levels of SC MNTX.

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Detailed Description

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Conditions

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Bowel Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

SC MNTX

Intervention Type DRUG

Dose 1

Arm 2

Group Type EXPERIMENTAL

SC MNTX

Intervention Type DRUG

Dose 2

Arm 3

Group Type EXPERIMENTAL

SC MNTX

Intervention Type DRUG

Dose 3

Interventions

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SC MNTX

Dose 1

Intervention Type DRUG

SC MNTX

Dose 2

Intervention Type DRUG

SC MNTX

Dose 3

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Must have advanced medical illness (cancer, HIV, etc) and be receiving palliative care
2. Must be on opioid medication for at least 2 weeks with no expectation of significant change in regimen
3. Must have constipation
4. Must be 18 yrs or older

Exclusion Criteria

1. Concurrent use of medications other than opioids which might interfere with gastrointestinal motility
2. Patients who received any experimental drug in the last 30 days
3. Patients with active peritoneal cancer (ovarian, etc.)
4. Patients with active diverticulitis or diverticulosis

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No