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

Primary Purpose

Constipation

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
N-methylnaltrexone bromide (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

Outcomes

Primary Outcome Measures

Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment

Secondary Outcome Measures

Full Information

First Posted
October 19, 2007
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
NCT00547586
Brief Title
Study Evaluating Oral MOA-728 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
October 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 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
Yes

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 with chronic pain, which is not due to malignant 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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
150 mg
Arm Type
Experimental
Arm Title
300 mg
Arm Type
Experimental
Arm Title
450 mg
Arm Type
Experimental
Arm Title
600 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
N-methylnaltrexone bromide (MOA-728)
Intervention Description
Oral
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment
Time Frame
6 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
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
City
Litchfield Park
State/Province
Arizona
ZIP/Postal Code
85340
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71901
Country
United States
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71903
Country
United States
City
Garden Grove
State/Province
California
ZIP/Postal Code
92843
Country
United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
City
Murrieta
State/Province
California
ZIP/Postal Code
30060
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
City
Chiefland
State/Province
Florida
ZIP/Postal Code
32626
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
City
Naples
State/Province
Florida
ZIP/Postal Code
34104
Country
United States
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
City
Spring Hill
State/Province
Florida
ZIP/Postal Code
34609
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
City
Sunset
State/Province
Louisiana
ZIP/Postal Code
70584
Country
United States
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
2301
Country
United States
City
Cadillac
State/Province
Michigan
ZIP/Postal Code
49601
Country
United States
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
City
Biloxi
State/Province
Mississippi
ZIP/Postal Code
39531
Country
United States
City
Ocean Springs
State/Province
Mississippi
ZIP/Postal Code
39564
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45439
Country
United States
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701
Country
United States
City
Colleyville
State/Province
Texas
ZIP/Postal Code
76034
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22304
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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