Clinical trial NCT00366431: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Constipation
Keywords: OIBD
OIC
Opioid
Constipation
Laxative
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2006-08-21
Enrollment: 420
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 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.


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.

Primary outcomes:
measure: 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 outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Tucson
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: Anaheim
country: United States
state: California
city: Anaheim
country: United States
state: California
city: Bakersfield
country: United States
state: California
city: Foothill Ranch
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: Los Gatos
country: United States
state: California
city: Orange
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: Trumbull
country: United States
state: Connecticut
city: Hollywood
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: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Ormond Beach
country: United States
state: Florida
city: Saint Cloud
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Dawsonville
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Bloomington
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Elkridge
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Brockton
country: United States
state: Massachusetts
city: Saginaw
country: United States
state: Michigan
city: Traverse City
country: United States
state: Michigan
city: Picayune
country: United States
state: Mississippi
city: Independence
country: United States
state: Missouri
city: Missoula
country: United States
state: Montana
city: Omaha
country: United States
state: Nebraska
city: Reno
country: United States
state: Nevada
city: Haddon Heights
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Great Neck
country: United States
state: New York
city: Lake Success
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Clinton
country: United States
state: Oklahoma
city: Chattanooga
country: United States
state: Tennessee
city: Beaumont
country: United States
state: Texas
city: Colleyville
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Alexandria
country: United States
state: Virginia
city: Christiansburg
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
Study officials:
affiliation: Bausch Health Americas, Inc.
name: Jeff Cohn
role: STUDY_DIRECTOR
References: