Clinical trial NCT00547586: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Constipation
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Progenics Pharmaceuticals, Inc.
First posted: 2007-10-22
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Litchfield Park
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Hot Springs
country: United States
state: Arkansas
city: Hot Springs
country: United States
state: Arkansas
city: Garden Grove
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Murrieta
country: United States
state: California
city: San Diego
country: United States
state: California
city: Chiefland
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Jupiter
country: United States
state: Florida
city: Largo
country: United States
state: Florida
city: Naples
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Ormond Beach
country: United States
state: Florida
city: Spring Hill
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Sunset
country: United States
state: Louisiana
city: Elkridge
country: United States
state: Maryland
city: Brockton
country: United States
state: Massachusetts
city: Cadillac
country: United States
state: Michigan
city: Traverse City
country: United States
state: Michigan
city: Biloxi
country: United States
state: Mississippi
city: Ocean Springs
country: United States
state: Mississippi
city: Las Vegas
country: United States
state: Nevada
city: Albuquerque
country: United States
state: New Mexico
city: Charlotte
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Dayton
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Medford
country: United States
state: Oregon
city: Chattanooga
country: United States
state: Tennessee
city: Beaumont
country: United States
state: Texas
city: Colleyville
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Alexandria
country: United States
state: Virginia
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: