Clinical trial NCT01427283: A Study of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain
Official title: A Randomized, Double-blind, Double-dummy, Placebo-controlled, Active-controlled, Parallel-group, Multicenter Trial of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess the Analgesic Efficacy (Compared to Placebo) and the Management of Opioid-induced Constipation (Compared to Oxycodone Controlled-release Tablets (OXY)) in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain and a History of Opioid-induced Constipation Who Require Around-the-clock Opioid Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Low Back Pain
Keywords: Low back pain
Chronic pain
Opioid
Constipation
Moderate to severe
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
First posted: 2011-09-01
Enrollment: 450
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 objective is to assess the efficacy of oxycodone/naloxone controlled-release tablets (OXN) for the management of opioid-induced constipation (OIC) compared with oxycodone controlled-release tablets (OXY) in subjects with moderate to severe low back pain and opioid-induced constipation who require around-the-clock opioid therapy.


Eligibility criteria: Inclusion Criteria include:

* Male and female subjects ≥ 18 years of age with moderate to severe, chronic low back pain (lasting at least several hours daily) as their predominant pain condition for at least 3 months prior to screening period;
* The low back pain must be related to nonmalignant and nonneuropathic conditions and may be with or without radiation;
* Subjects must have a self-reported history of opioid induced constipation (OIC).

Exclusion Criteria include:

* Subjects with rheumatoid arthritis or other inflammatory arthritis;
* Subjects with neuropathic conditions that have been painful or required therapy within the past 3 months;
* Subjects with evidence of significant structural abnormalities of the gastrointestinal (GI) tract or other significant conditions affecting GI motility;
* Subjects with chronic constipation not related to opioid use;
* Subjects who had surgical procedures directed towards the source of chronic low back pain within 6 months of the screening visit or planned during the study;
* Subjects with a history of malignancy within past 2 years, with exception of basal cell carcinoma that has been successfully treated.

Other protocol specific inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Overall complete spontaneous bowel movement (CSBM) responder rates
timeFrame: Weeks 1 through 12
Secondary outcomes:
measure: CSBM Responder at least 50% of the weeks in the double-blind period
timeFrame: Weeks 1 through 12
measure: Laxative-free Responder at least 50% of the weeks in the double-blind period
timeFrame: Weeks 1 through 12
Other outcomes:
Locations:
city: Alabaster
country: United States
facility: Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Investigational Site
state: Alabama
city: Foley
country: United States
facility: Investigational Site
state: Alabama
city: Mobile
country: United States
facility: Investigational Site
state: Alabama
city: Mesa
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facility: Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Investigational Site
state: Arizona
city: Phoenix
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facility: Investigational Site
state: Arizona
city: Sun Lakes
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state: Arizona
city: Tucson
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city: Tucson
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city: Little Rock
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state: Arkansas
city: Sherwood
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state: Arkansas
city: Anaheim
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state: California
city: Anaheim
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state: California
city: Artesia
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state: California
city: Cerritos
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state: California
city: Chino
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state: California
city: El Cajon
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state: California
city: Encino
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state: California
city: Fountain Valley
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state: California
city: Fresno
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state: California
city: Garden Grove
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state: California
city: Garden Grove
country: United States
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state: California
city: Laguna Hills
country: United States
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state: California
city: Lakewood
country: United States
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state: California
city: Lincoln
country: United States
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state: California
city: Lomita
country: United States
facility: Investigational Site
state: California
city: Long Beach
country: United States
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state: California
city: Oceanside
country: United States
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state: California
city: Orange
country: United States
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state: California
city: Paramount
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state: California
city: Sacramento
country: United States
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state: California
city: San Bernardino
country: United States
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state: California
city: San Diego
country: United States
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state: California
city: San Diego
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state: California
city: Thousand Oaks
country: United States
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state: California
city: Torrance
country: United States
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state: California
city: Colorado Springs
country: United States
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state: Colorado
city: Colorado Springs
country: United States
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state: Colorado
city: Denver
country: United States
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state: Colorado
city: Golden
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state: Colorado
city: Aventura
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state: Florida
city: Bradenton
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state: Florida
city: Chiefland
country: United States
facility: Investigational Site
state: Florida
city: Clermont
country: United States
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state: Florida
city: Daytona Beach
country: United States
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state: Florida
city: Deland
country: United States
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state: Florida
city: Edgewater
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facility: Investigational Site
state: Florida
city: Ft. Lauderdale
country: United States
facility: Investigational Site
state: Florida
city: Ft. Myers
country: United States
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state: Florida
city: Hialeah
country: United States
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city: Hialeah
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state: Florida
city: Inverness
country: United States
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state: Florida
city: Jacksonville
country: United States
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state: Florida
city: Jacksonville
country: United States
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state: Florida
city: Jacksonville
country: United States
facility: Investigational Site
state: Florida
city: Miami Beach
country: United States
facility: Investigational Site
state: Florida
city: Miami
country: United States
facility: Investigational Site
state: Florida
city: Miami
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state: Florida
city: Miami
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state: Florida
city: Miami
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city: Miami
country: United States
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city: Miami
country: United States
facility: Investigational Site
state: Florida
city: Miami
country: United States
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state: Florida
city: Miami
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state: Florida
city: Miami
country: United States
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state: Florida
city: Naples
country: United States
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state: Florida
city: Naples
country: United States
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state: Florida
city: New Smyrna Beach
country: United States
facility: Investigational Site
state: Florida
city: North Miami
country: United States
facility: Investigational Site
state: Florida
city: Oldsmar
country: United States
facility: Investigational Site
state: Florida
city: Orlando
country: United States
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state: Florida
city: Oviedo
country: United States
facility: Investigational Site
state: Florida
city: Plantation
country: United States
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state: Florida
city: Tamarac
country: United States
facility: Investigational Site
state: Florida
city: Tampa
country: United States
facility: Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Investigational Site
state: Georgia
city: Austell
country: United States
facility: Investigational Site
state: Georgia
city: Snellville
country: United States
facility: Investigational Site
state: Georgia
city: Boise
country: United States
facility: Investigational Site
state: Idaho
city: Boise
country: United States
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state: Idaho
city: Chicago
country: United States
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state: Illinois
city: Chicago
country: United States
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city: Chicago
country: United States
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city: Evansville
country: United States
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city: Indianapolis
country: United States
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city: Michigan City
country: United States
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city: Edgewood
country: United States
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state: Kentucky
city: Lake Charles
country: United States
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state: Louisiana
city: Monroe
country: United States
facility: Investigational Site
state: Louisiana
city: New Orleans
country: United States
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state: Louisiana
city: Pikesville
country: United States
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state: Maryland
city: Brockton
country: United States
facility: Investigational Site
state: Massachusetts
city: Worcester
country: United States
facility: Investigational Site
state: Massachusetts
city: Florissant
country: United States
facility: Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: Investigational Site
state: Nevada
city: Atco
country: United States
facility: Investigational Site
state: New Jersey
city: Great Neck
country: United States
facility: Investigational Site
state: New York
city: Kew Gardens
country: United States
facility: Investigational Site
state: New York
city: New York
country: United States
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state: New York
city: Rochester
country: United States
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state: New York
city: Williamsville
country: United States
facility: Investigational Site
state: New York
city: Durham
country: United States
facility: Investigational Site
state: North Carolina
city: Elkin
country: United States
facility: Investigational Site
state: North Carolina
city: High Point
country: United States
facility: Investigational Site
state: North Carolina
city: Winston Salem
country: United States
facility: Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: Investigational Site
state: Ohio
city: Dayton
country: United States
facility: Investigational Site
state: Ohio
city: Moraine
country: United States
facility: Investigational Site
state: Ohio
city: Toledo
country: United States
facility: Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Investigational Site
state: Oklahoma
city: Eugene
country: United States
facility: Investigational Site
state: Oregon
city: Jenkintown
country: United States
facility: Investigational Site
state: Pennsylvania
city: Levittown
country: United States
facility: Investigational Site
state: Pennsylvania
city: Mechanicsburg
country: United States
facility: Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Investigational Site
state: Pennsylvania
city: Red Lion
country: United States
facility: Investigational Site
state: Pennsylvania
city: State College
country: United States
facility: Investigational Site
state: Pennsylvania
city: Warwick
country: United States
facility: Investigational Site
state: Rhode Island
city: Charleston
country: United States
facility: Investigational Site
state: South Carolina
city: Myrtle Beach
country: United States
facility: Investigational Site
state: South Carolina
city: Rapid City
country: United States
facility: Investigational Site
state: South Dakota
city: Jackson
country: United States
facility: Investigational Site
state: Tennessee
city: Allen
country: United States
facility: Investigational Site
state: Texas
city: Austin
country: United States
facility: Investigational Site
state: Texas
city: Dallas
country: United States
facility: Investigational Site
state: Texas
city: Dallas
country: United States
facility: Investigational Site
state: Texas
city: Dallas
country: United States
facility: Investigational Site
state: Texas
city: Dallas
country: United States
facility: Investigational Site
state: Texas
city: Houston
country: United States
facility: Investigational Site
state: Texas
city: Houston
country: United States
facility: Investigational Site
state: Texas
city: Houston
country: United States
facility: Investigational Site
state: Texas
city: Houston
country: United States
facility: Investigational Site
state: Texas
city: McKinney
country: United States
facility: Investigational Site
state: Texas
city: North Richland Hills
country: United States
facility: Investigational Site
state: Texas
city: Tomball
country: United States
facility: Investigational Site
state: Texas
city: Orem
country: United States
facility: Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Investigational Site
state: Utah
city: Danville
country: United States
facility: Investigational Site
state: Virginia
city: Midlothian
country: United States
facility: Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Investigational Site
state: Virginia
city: Bothell
country: United States
facility: Investigational Site
state: Washington
Study officials:
References: