Study of Methylnaltrexone (MNTX) for the Relief of Constipation

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

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2005-10-31

Brief Summary

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To determine the efficacy of subcutaneous MNTX to relieve opioid-induced constipation in patients with advanced medical illness.

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Detailed Description

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This is a multi-center, double-blind, randomized parallel group study conducted in patients with advanced medical illness and opioid-induced constipation. Eligible patients are randomly assigned to receive SC doses of either MNTX, dose 1 or placebo every other day for 2 weeks. At Day 8, eligible patients, if allowed, could be escalated to a a higher dose of MNTX.

Conditions

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Advance Illness Patients With OIC

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 2

Group Type PLACEBO_COMPARATOR

SC Placebo

Intervention Type DRUG

Interventions

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SC Methylnaltrexone

Dose 1

Intervention Type DRUG

SC Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18 years of age and older
* Negative pregnancy test (serum or urine) at screening for all women of childbearing potential
* Advanced Medical Illness (i.e., terminal illness, such as incurable cancer or end of stage AIDS) with life expectancy of ≥ 1 month
* patient must sign ICF

Exclusion Criteria

* Women who are pregnant and/or nursing
* Previous treatment with MNTX
* Participation in any other studies involving investigational products within 30 days prior to screening

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No