Study Evaluating Safety & Efficacy of Subcutaneous Methylnaltrexone on Opioid-Induced Constipation in Cancer Subjects

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

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-08-31

Brief Summary

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This purpose of this study is to evaluate the safety and effectiveness of a subcutaneous (injection beneath the skin) form of methylnaltrexone in subjects who have cancer-related pain and constipation from taking opioids. The length of participation will be up to 7 weeks.

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Detailed Description

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Conditions

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Opioid-Induced Constipation

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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Group 1 Active Drug

Methylnaltrexone

Group Type EXPERIMENTAL

methylnaltrexone

Intervention Type DRUG

Group 2 Non-Active Drug

Placebo

Eligibility Criteria

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Inclusion Criteria

* Is a man or woman aged 18 years or older.
* Has a body weight \>= 38 kg.
* Has cancer (active or in remission), and has cancer-related pain (ie, pain due to cancer or treatment of cancer).
* Has a life expectancy of \>= 6 months.
* Has a performance status of 0, 1, or 2 based on the Eastern Cooperative Oncology Group (ECOG) scale.
* Is taking opioids for cancer-related pain, and not just as-needed doses.
* Has a diagnosis of OIC as determined by the investigator.
* Is willing to follow the protocol instructions on laxative use during the study.

Exclusion Criteria

* Has a history of chronic constipation before starting opioids.
* Has renal disease receiving dialysis.
* Has an ostomy for stools.
* Is a pregnant or breastfeeding woman.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No