A a Single Dose Efficacy Study in Inducing Laxation in Advance Illness Patients

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

PHASE3

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2005-02-28

Brief Summary

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To test the effectiveness of MNTX in advanced illness subjects.

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Detailed Description

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To determine the efficacy of MNTX compared to placebo to induce laxation in patients receiving opioids.

Conditions

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Advanced Illness Patients With Opioid Induced Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Arm 1

Group Type EXPERIMENTAL

SC Methylnaltrexone

Intervention Type DRUG

Dose 1

Arm 3

Group Type PLACEBO_COMPARATOR

SC Placebo

Intervention Type DRUG

Arm 2

Group Type EXPERIMENTAL

SC Methylnaltrexone

Intervention Type DRUG

Dose 2

Interventions

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SC Methylnaltrexone

Dose 1

Intervention Type DRUG

SC Placebo

Intervention Type DRUG

SC Methylnaltrexone

Dose 2

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Advanced medical illness with a life expectancy of 1 to 6 months
2. No clinically significant laxation within 48 hours prior to the first dose of study drug
3. On stable opioid and laxative regimen for a least 3 days prior to treatment
4. Age greater than 18years
5. Females of child-bearing age must have a negative pregnancy test.

Exclusion Criteria

1. Females who are pregnant or nursing.
2. Previous treatment with MNTX or prior treatment with naltrexone or naloxone for treatment of OIC
3. Any disease process suggestive of gastrointestinal obstruction
4. Fecal ostomy.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No