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

August 8, 2020 updated by: Bausch Health Americas, Inc.

A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study of Oral MOA-728 for the Treatment of Opioid- Induced Bowel Dysfunction in Subjects With Chronic Nonmalignant Pain

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
    • Arizona
      • Litchfield Park, Arizona, United States, 85340
      • Tucson, Arizona, United States, 85741
      • Tucson, Arizona, United States, 85710
    • Arkansas
      • Hot Springs, Arkansas, United States, 71901
      • Hot Springs, Arkansas, United States, 71903
    • California
      • Garden Grove, California, United States, 92843
      • Long Beach, California, United States, 90813
      • Los Angeles, California, United States, 90048
      • Murrieta, California, United States, 30060
      • San Diego, California, United States, 92121
    • Florida
      • Chiefland, Florida, United States, 32626
      • Jacksonville, Florida, United States, 32216
      • Jupiter, Florida, United States, 33458
      • Largo, Florida, United States, 33770
      • Naples, Florida, United States, 34104
      • Ocala, Florida, United States, 34471
      • Ormond Beach, Florida, United States, 32174
      • Spring Hill, Florida, United States, 34609
    • Illinois
      • Chicago, Illinois, United States, 60610
    • Indiana
      • Indianapolis, Indiana, United States, 46250
    • Louisiana
      • Sunset, Louisiana, United States, 70584
    • Maryland
      • Elkridge, Maryland, United States, 21075
    • Massachusetts
      • Brockton, Massachusetts, United States, 2301
    • Michigan
      • Cadillac, Michigan, United States, 49601
      • Traverse City, Michigan, United States, 49684
    • Mississippi
      • Biloxi, Mississippi, United States, 39531
      • Ocean Springs, Mississippi, United States, 39564
    • Nevada
      • Las Vegas, Nevada, United States, 89119
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
      • Winston-Salem, North Carolina, United States, 27103
    • Ohio
      • Dayton, Ohio, United States, 45439
      • Toledo, Ohio, United States, 43623
    • Oregon
      • Medford, Oregon, United States, 97504
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
    • Texas
      • Beaumont, Texas, United States, 77701
      • Colleyville, Texas, United States, 76034
      • Dallas, Texas, United States, 75230
      • San Antonio, Texas, United States, 78229
    • Virginia
      • Alexandria, Virginia, United States, 22304

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: placebo
placebo
Experimental: 300 mg
Drug: N-methylnaltrexone bromide (MOA-728)
Oral
Experimental: 600 mg
Drug: N-methylnaltrexone bromide (MOA-728)
Oral
Experimental: 150 mg
Drug: N-methylnaltrexone bromide (MOA-728)
Oral
Experimental: 450 mg
Drug: N-methylnaltrexone bromide (MOA-728)
Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment
Time Frame: 6 hours
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch Health Americas, Inc.

Collaborators

Progenics Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

October 19, 2007

First Submitted That Met QC Criteria

October 19, 2007

First Posted (Estimate)

October 22, 2007

Study Record Updates

Last Update Posted (Actual)

August 20, 2020

Last Update Submitted That Met QC Criteria

August 8, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3200A3-2201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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