Back to resultsStudy Evaluating Oral MOA-728 for the Treatment of Opioid-Induced Bowel Dysfunction (OIBD) in Subjects With Chronic Non-Malignant Pain
Primary Purpose
Constipation
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MOA-728
Sponsored by
About this trial
This is an interventional treatment trial for Constipation focused on measuring OIBD, OIC, Opioid, Constipation, Laxative
Eligibility Criteria
Inclusion Criteria: Adult outpatients with opioid-induced bowel dysfunction and chronic non-malignant pain. Taking oral, transdermal, intravenous, or subcutaneous opioids. Willingness to discontinue all pre-study laxative therapy and utilize 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
Outcomes
Primary Outcome Measures
The effect of the interventional treatment will be measured by the change from baseline in the number of bowel movements per week during the double-blind treatment period.
Secondary Outcome Measures
Full Information
NCT ID
NCT00366431
First Posted
August 18, 2006
Last Updated
November 21, 2019
Sponsor
Bausch Health Americas, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00366431
Brief Title
Study Evaluating Oral MOA-728 for the Treatment of Opioid-Induced Bowel Dysfunction (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 Non-Malignant Pain
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bausch Health Americas, Inc.
4. Oversight
5. Study Description
Brief Summary
The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of MOA-728 in subjects with Opioid-Induced Bowel Dysfunction (OIBD) with associated chronic non-malignant pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
OIBD, OIC, Opioid, Constipation, Laxative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
420 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MOA-728
Primary Outcome Measure Information:
Title
The effect of the interventional treatment will be measured by the change from baseline in the number of bowel movements per week during the double-blind treatment period.
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 non-malignant pain.
Taking oral, transdermal, intravenous, or subcutaneous opioids.
Willingness to discontinue all pre-study laxative therapy and utilize 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
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35215
Country
United States
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85029
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
City
Bakersfield
State/Province
California
ZIP/Postal Code
93311
Country
United States
City
Foothill Ranch
State/Province
California
ZIP/Postal Code
92610
Country
United States
City
Garden Grove
State/Province
California
ZIP/Postal Code
92843
Country
United States
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
City
Orange
State/Province
California
ZIP/Postal Code
92869
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95831
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
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
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33180
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
Saint Cloud
State/Province
Florida
ZIP/Postal Code
34769
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
City
Dawsonville
State/Province
Georgia
ZIP/Postal Code
30534
Country
United States
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30066
Country
United States
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
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
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48602
Country
United States
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
City
Picayune
State/Province
Mississippi
ZIP/Postal Code
39466
Country
United States
City
Independence
State/Province
Missouri
ZIP/Postal Code
64055
Country
United States
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
City
Haddon Heights
State/Province
New Jersey
ZIP/Postal Code
08035
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45224
Country
United States
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45439
Country
United States
City
Clinton
State/Province
Oklahoma
ZIP/Postal Code
73601
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
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78238
Country
United States
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22304
Country
United States
City
Christiansburg
State/Province
Virginia
ZIP/Postal Code
24073
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating Oral MOA-728 for the Treatment of Opioid-Induced Bowel Dysfunction (OIBD) in Subjects With Chronic Non-Malignant Pain
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