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Study Evaluating MOA-728 Oral for the Treatment of OIBD in Subjects With Chronic Non-Malignant Pain

Primary Purpose

Constipation

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MOA-728
Placebo
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Placebo

    150 mg

    300 mg

    450 mg

    600 mg

    Arm Description

    Placebo

    MOA-728

    MOA-728

    MOA-728

    MOA-728

    Outcomes

    Primary Outcome Measures

    Percentage of Participants Witn Spontaneous Bowel Movements Within 3 Hours of Treatment

    Secondary Outcome Measures

    Full Information

    First Posted
    January 18, 2008
    Last Updated
    August 8, 2020
    Sponsor
    Bausch Health Americas, Inc.
    Collaborators
    Progenics Pharmaceuticals, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00605644
    Brief Title
    Study Evaluating MOA-728 Oral for the Treatment of OIBD in Subjects With Chronic Non-Malignant Pain
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2008 (undefined)
    Primary Completion Date
    May 2008 (Actual)
    Study Completion Date
    May 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bausch Health Americas, Inc.
    Collaborators
    Progenics Pharmaceuticals, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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 administered MOA-728 who have chronic pain that is not due to cancer, and who have opioid-induced bowel dysfunction (OIBD).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Constipation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    128 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Arm Title
    150 mg
    Arm Type
    Experimental
    Arm Description
    MOA-728
    Arm Title
    300 mg
    Arm Type
    Experimental
    Arm Description
    MOA-728
    Arm Title
    450 mg
    Arm Type
    Experimental
    Arm Description
    MOA-728
    Arm Title
    600 mg
    Arm Type
    Experimental
    Arm Description
    MOA-728
    Intervention Type
    Drug
    Intervention Name(s)
    MOA-728
    Intervention Description
    Oral Capsules
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo
    Primary Outcome Measure Information:
    Title
    Percentage of Participants Witn Spontaneous Bowel Movements Within 3 Hours of Treatment
    Time Frame
    3 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jeff Cohn
    Organizational Affiliation
    Bausch Health Americas, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Study Evaluating MOA-728 Oral for the Treatment of OIBD in Subjects With Chronic Non-Malignant Pain

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