Study Evaluating Oral MOA-728 For The Treatment Of OIBD In Subjects With Chronic Non-Malignant Pain

NCT ID: NCT00547586

Last Updated: 2020-08-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-02-29

Brief Summary

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The primary purpose of this study is to evaluate the safety and dose-response relationship of N-methylnaltrexone bromide (MOA-728) by observing spontaneous bowel movements in subjects with chronic pain, which is not due to malignant cancer, and who have opioid-induced bowel dysfunction (OIBD).

Detailed Description

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Conditions

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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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Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

placebo

150 mg

Group Type EXPERIMENTAL

N-methylnaltrexone bromide (MOA-728)

Intervention Type DRUG

Oral

300 mg

Group Type EXPERIMENTAL

N-methylnaltrexone bromide (MOA-728)

Intervention Type DRUG

Oral

450 mg

Group Type EXPERIMENTAL

N-methylnaltrexone bromide (MOA-728)

Intervention Type DRUG

Oral

600 mg

Group Type EXPERIMENTAL

N-methylnaltrexone bromide (MOA-728)

Intervention Type DRUG

Oral

Interventions

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N-methylnaltrexone bromide (MOA-728)

Oral

Intervention Type DRUG

placebo

placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult outpatients with opioid-induced bowel dysfunction and chronic pain, which is not due to malignant cancer.
* Taking oral, transdermal, intravenous, or subcutaneous opioids.
* Willingness to discontinue all pre-study laxative therapy and use only study permitted rescue laxatives.

Exclusion Criteria

* History of chronic constipation before the initiation of opioid therapy.
* Other GI disorders known to affect bowel transit.
* Women who are pregnant, breast-feeding, or plan to become pregnant.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Progenics Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role collaborator

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Mobile, Alabama, United States

Site Status

Litchfield Park, Arizona, United States

Site Status

Tucson, Arizona, United States

Site Status

Tucson, Arizona, United States

Site Status

Hot Springs, Arkansas, United States

Site Status

Hot Springs, Arkansas, United States

Site Status

Garden Grove, California, United States

Site Status

Long Beach, California, United States

Site Status

Los Angeles, California, United States

Site Status

Murrieta, California, United States

Site Status

San Diego, California, United States

Site Status

Chiefland, Florida, United States

Site Status

Jacksonville, Florida, United States

Site Status

Jupiter, Florida, United States

Site Status

Largo, Florida, United States

Site Status

Naples, Florida, United States

Site Status

Ocala, Florida, United States

Site Status

Ormond Beach, Florida, United States

Site Status

Spring Hill, Florida, United States

Site Status

Chicago, Illinois, United States

Site Status

Indianapolis, Indiana, United States

Site Status

Sunset, Louisiana, United States

Site Status

Elkridge, Maryland, United States

Site Status

Brockton, Massachusetts, United States

Site Status

Cadillac, Michigan, United States

Site Status

Traverse City, Michigan, United States

Site Status

Biloxi, Mississippi, United States

Site Status

Ocean Springs, Mississippi, United States

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Las Vegas, Nevada, United States

Site Status

Albuquerque, New Mexico, United States

Site Status

Charlotte, North Carolina, United States

Site Status

Winston-Salem, North Carolina, United States

Site Status

Dayton, Ohio, United States

Site Status

Toledo, Ohio, United States

Site Status

Medford, Oregon, United States

Site Status

Chattanooga, Tennessee, United States

Site Status

Beaumont, Texas, United States

Site Status

Colleyville, Texas, United States

Site Status

Dallas, Texas, United States

Site Status

San Antonio, Texas, United States

Site Status

Alexandria, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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3200A3-2201

Identifier Type: -

Identifier Source: org_study_id

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