Clinical trial NCT01358526: Efficacy and Safety of Oxycodone/Naloxone Controlled-release Tablets (OXN) Compared to Placebo in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Trial With an Enriched Study Design to Assess the Efficacy and Safety of Oxycodone/Naloxone Controlled-release Tablets (OXN) Compared to Placebo in Opioid-experienced Subjects With Moderate to Severe Pain Due to Chronic Low Back Pain 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
Moderate to severe chronic low back pain
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
First posted: 2011-05-23
Enrollment: 1095
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 of this study is to assess the efficacy and safety of OXN compared to placebo in opioid-experienced subjects with moderate to severe pain due to chronic low back pain 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 back pain must be related to nonmalignant and nonneuropathic conditions and without radiation or with only proximal radiation (above the knee);
* Subjects must be on opioid analgesic therapy for low back pain which:
* Has been ongoing for at least 4 weeks prior to the screening visit and,
* Consists of a stable opioid regimen at a total average daily dose equivalent to 20 to 160 mg (inclusive) of morphine for the last 2 weeks prior to the screening visit. Subjects taking tramadol ≥ 100 mg daily on a stable regimen for the last 2 weeks prior to the screening visit will also meet this criterion;
* Subjects must require continuation of opioid analgesic treatment in the range of 40 to 160 mg (inclusive) of morphine or its equivalent daily and be likely to benefit from chronic around-the-clock opioid therapy for the duration of the study;
* Subjects must have an average pain over the last 14 days score ≥ 5 (on an 11-point numerical rating scale \[NRS\]) at the screening visit, on their current opioid analgesic medication and, if applicable, nonopioid medication;
* Subjects must have an average pain over the last 24 hours score ≥ 5 (on an 11-point NRS) at the screening visit, on their current opioid analgesic medication and, if applicable, nonopioid medication;
* Subjects must be willing and able to be compliant with the protocol, capable of subjective evaluation, able to read and understand questionnaires, willing and able to use a diary per protocol, and read, understand, and sign the written informed consent in English.

Exclusion Criteria include:

* Female subjects who are pregnant (positive serum beta human chorionic gonadotropin \[β hCG\] test) or lactating;
* Subjects with any contraindication or any history of hypersensitivity to oxycodone, naloxone, or other opioids. This does not include subjects who have experienced common opioid side effects (e.g., nausea, constipation);
* Subjects with acute spinal cord compression, acute compression fracture, seronegative spondyloarthropathy, acute nerve root compression, cauda equina compression, fibromyalgia, reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), diabetic amyotrophy, meningitis, discitis, or back pain due to secondary infection, tumor, or postherpetic neuralgia;
* Subjects with gout, unless controlled on stable suppressive treatment with colchicine or uric-acid-lowering therapy without any attacks for ≥ 2 years and the subject has not been using nonsteroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors on a regular basis;
* Subjects with pseudogout, psoriatic arthritis, active Lyme disease, rheumatoid arthritis or other inflammatory arthritis, or neuropathic pain conditions;
* 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 opioid, alcohol, medication, or illicit drug abuse or addiction;
* Subjects who have received any investigational medication within 30 days of first dose of study drug;
* Subjects currently taking, or who have taken naloxone, naltrexone, methylnaltrexone, or alvimopan within 10 days before the screening visit;
* Subjects who have received study drug in a clinical study of oxycodone/naloxone controlled-release (OXN or ONU).

Other protocol specific inclusion/exclusion criteria may apply.

Primary outcomes:
measure: The "Average Pain Over the Last 24 Hours" at Week 12 of the Double-blind Period
timeFrame: 24 hours (Week 12)
Secondary outcomes:
measure: The Sleep Disturbance Subscale of the MOS Sleep Scale at Weeks 4, 8, and 12
timeFrame: Weeks 4, 8, and 12
measure: Patient Global Impression of Change (PGIC)
timeFrame: Week 12
Other outcomes:
measure: Responder Analysis for Subjects With a ≥ 30% Reduction in Pain Compared to Baseline
timeFrame: Week 12
measure: Responder Analysis for Subjects With a ≥ 50% Reduction in Pain Compared to Baseline
timeFrame: Week 12
Locations:
city: Birmingham
country: United States
facility: Alabama Orthopaedic Center, PC
state: Alabama
city: Birmingham
country: United States
facility: Alliance Clinical Research
state: Alabama
city: Haleyville
country: United States
facility: Winston Technology Research, LLC
state: Alabama
city: Huntsville
country: United States
facility: Monte Sano Clinical Research, LLC
state: Alabama
city: Mobile
country: United States
facility: Research Facility
state: Alabama
city: Chandler
country: United States
facility: Radiant Research, Inc.
state: Arizona
city: Phoenix
country: United States
facility: Dedicated Clinical Research
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Phoenix
country: United States
facility: Clinical Research Advantage, Inc./Tatum Highlands Medical Associates, PLLC
state: Arizona
city: Tucson
country: United States
facility: Quality of Life Medical & Research Center, LLC
state: Arizona
city: Little Rock
country: United States
facility: Ortho Surgeons
state: Arkansas
city: Anaheim
country: United States
facility: Orange County Research Institute
state: California
city: Anaheim
country: United States
facility: Physician Alliance Research Center
state: California
city: Arcadia
country: United States
facility: Advanced Pain Research Institute
state: California
city: Buena Park
country: United States
facility: Southbay Pharma Research
state: California
city: Burbank
country: United States
facility: Providence Clinical Research
state: California
city: Carmichael
country: United States
facility: Med Center
state: California
city: Castro Valley
country: United States
facility: Advanced Pain Management and Rehabilitation Medical Group, Inc.
state: California
city: Chino
country: United States
facility: Catalina Research Institute, LLC
state: California
city: Escondido
country: United States
facility: Synergy Clinical Research of Escondido
state: California
city: Fresno
country: United States
facility: Valley Research
state: California
city: Garden Grove
country: United States
facility: RX Clinical Research, Inc.
state: California
city: La Mesa
country: United States
facility: TriWest Research Associates
state: California
city: Laguna Hills
country: United States
facility: Pacific Coast Pain Management Center
state: California
city: Laguna Hills
country: United States
facility: South Orange County Surgical Medical Group
state: California
city: Lincoln
country: United States
facility: Clinical Trials Research
state: California
city: Los Angeles
country: United States
facility: L.A. Pain and Wellness Institute
state: California
city: Newport Beach
country: United States
facility: Newport Beach Clinical Research Associates, Inc.
state: California
city: Pasadena
country: United States
facility: Lotus Clinical Research
state: California
city: Redding
country: United States
facility: Northern California Clinical Research Center
state: California
city: Riverside
country: United States
facility: Probe Clinical Research Corporation
state: California
city: Sacramento
country: United States
facility: Northern California Research
state: California
city: Santa Ana
country: United States
facility: Probe Clinical Research Corporation
state: California
city: Denver
country: United States
facility: Denver Internal Medicine Group
state: Colorado
city: Wheat Ridge
country: United States
facility: Front Range Clinical Research
state: Colorado
city: Trumbull
country: United States
facility: New England Research Associates, LLC
state: Connecticut
city: Boynton Beach
country: United States
facility: Orthopedic Research Institute
state: Florida
city: Bradenton
country: United States
facility: Coastal Orthopedics & Pain Management
state: Florida
city: Chiefland
country: United States
facility: Southeast Clinical Research, LLC
state: Florida
city: Clearwater
country: United States
facility: Innovative Research of West Florida, Inc.
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Debary
country: United States
facility: Omega Research Consultants, LLC
state: Florida
city: Fort Lauderdale
country: United States
facility: S & W Clinical Research
state: Florida
city: Gainesville
country: United States
facility: Southeastern Integrated Medical, PL
state: Florida
city: Hialeah
country: United States
facility: Health Care Family Rehab & Research Center
state: Florida
city: Hialeah
country: United States
facility: Eastern Research, Inc.
state: Florida
city: Jacksonville
country: United States
facility: Southeast Clinical Research, LLC
state: Florida
city: Jacksonville
country: United States
facility: Florida Institute of Medical Research
state: Florida
city: Jupiter
country: United States
facility: Drug Study Institute
state: Florida
city: Miami
country: United States
facility: Pharma Care Research, Inc.
state: Florida
city: Miami
country: United States
facility: Advanced Pharma CR, LLC
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Ormond Beach
country: United States
facility: Peninsula Research, Inc.
state: Florida
city: Sarasota
country: United States
facility: Sarasota Clinical Research, LLC
state: Florida
city: Sarasota
country: United States
facility: Sarasota Pain Medicine Research
state: Florida
city: Tamarac
country: United States
facility: Vita Research Solutions & Medical Center, Inc.
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials
state: Florida
city: Trinity
country: United States
facility: Advanced Research Institute, Inc.
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Winter Park
country: United States
facility: National Pain Research Institute, LLC
state: Florida
city: Atlanta
country: United States
facility: Independent Neurodiagnostic Clinic
state: Georgia
city: Duluth
country: United States
facility: In-Quest Medical Research, LLC
state: Georgia
city: Marietta
country: United States
facility: Georgia Institute for Clinical Research, LLC
state: Georgia
city: Marietta
country: United States
facility: Research Facility
state: Georgia
city: Newnan
country: United States
facility: Better Health Clinical Research, Inc.
state: Georgia
city: Savannah
country: United States
facility: SouthCoast Medical Group
state: Georgia
city: Snellville
country: United States
facility: Georgia Clinical Research, LLC
state: Georgia
city: Boise
country: United States
facility: The Pain Center
state: Idaho
city: Gurnee
country: United States
facility: Clinical Investigation Specialists, Inc.
state: Illinois
city: Evansville
country: United States
facility: Destiny Clinical Research, LLC
state: Indiana
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: Valparaiso
country: United States
facility: Northwest Indiana Center for Clinical Research
state: Indiana
city: Leawood
country: United States
facility: International Clinical Research Institute, Inc.
state: Kansas
city: Prairie Village
country: United States
facility: Clinical Trials Technology, Inc. CTT Consultants, Inc.
state: Kansas
city: Lexington
country: United States
facility: The Pain Treatment Center of the Bluegrass
state: Kentucky
city: New Orleans
country: United States
facility: Louisiana Research Associates, Inc.
state: Louisiana
city: New Orleans
country: United States
facility: Research Facility
state: Louisiana
city: Hollywood
country: United States
facility: Mid-Atlantic Medical Research Centers
state: Maryland
city: Pikesville
country: United States
facility: MidAtlantic Pain Medicine Center
state: Maryland
city: Brockton
country: United States
facility: Beacon Clinical Research, LLC
state: Massachusetts
city: Haverhill
country: United States
facility: ActivMed Practices and Research
state: Massachusetts
city: Watertown
country: United States
facility: Medvadis Research Corporation
state: Massachusetts
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
city: Cadillac
country: United States
facility: Great Lakes Family Care
state: Michigan
city: Pinconning
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
city: Saint Louis
country: United States
facility: Medex Healthcare Research, Inc.
state: Missouri
city: St. Louis
country: United States
facility: Mercy Health Research
state: Missouri
city: St. Louis
country: United States
facility: Sundance Clinical Research, LLC
state: Missouri
city: Omaha
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Las Vegas
country: United States
facility: Research Facility
state: Nevada
city: Blackwood
country: United States
facility: South Jersey Medical Associates, P.A.
state: New Jersey
city: Stratford
country: United States
facility: University of Medicine & Dentistry of New Jersey - School of Osteopathic Medicine (UMDNJ)
state: New Jersey
city: Cedarhurst
country: United States
facility: Five Towns Neuroscience Research/Five Towns Neurology
state: New York
city: Great Neck
country: United States
facility: Long Island Gastrointestinal Research Group, LLP
state: New York
city: New York
country: United States
facility: Medex Healthcare Research, Inc.
state: New York
city: New York
country: United States
facility: Research Across America
state: New York
city: Williamsville
country: United States
facility: Upstate Clinical Research Associates, LLC
state: New York
city: Charlotte
country: United States
facility: Gaffney Health Services
state: North Carolina
city: Charlotte
country: United States
facility: Box Arthritis & Rheumatology of the Carolinas, PLLC
state: North Carolina
city: Greensboro
country: United States
facility: PharmQuest
state: North Carolina
city: High Point
country: United States
facility: Peters Medical Research
state: North Carolina
city: Fargo
country: United States
facility: Plains Medical Clinic, LLC
state: North Dakota
city: Beavercreek
country: United States
facility: Clinical Inquest Center Ltd.
state: Ohio
city: Cincinnati
country: United States
facility: Community Research
state: Ohio
city: Columbus
country: United States
facility: Columbus Clinical Research, Inc.
state: Ohio
city: Dayton
country: United States
facility: Hometown Urgent Care and Research
state: Ohio
city: Franklin
country: United States
facility: Prestige Clinical Research
state: Ohio
city: Springfield
country: United States
facility: Hometown Urgent Care and Research
state: Ohio
city: Tiffin
country: United States
facility: J L Clinical Research
state: Ohio
city: Toledo
country: United States
facility: Bone Joint and Spine Surgeons, Inc.
state: Ohio
city: Zanesville
country: United States
facility: Pharmacotherapy Research Associates, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: Neuropsychiatric Center and NPC Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Health Research Institute
state: Oklahoma
city: Oklahoma City
country: United States
facility: Paradigm Research Professionals, LLC
state: Oklahoma
city: Bend
country: United States
facility: Bend Memorial Clinic
state: Oregon
city: Eugene
country: United States
facility: Pain Consultants of Oregon
state: Oregon
city: Eugene
country: United States
facility: Willamette Valley Clinical Studies
state: Oregon
city: Medford
country: United States
facility: Sunstone Medical Research, LLC
state: Oregon
city: Altoona
country: United States
facility: Allegheny Pain Management, PC
state: Pennsylvania
city: Bridgeville
country: United States
facility: Paramount Clinical Research
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Jenkintown
country: United States
facility: The Clinical Trial Center, LLC
state: Pennsylvania
city: Mechanicsburg
country: United States
facility: Central Pennsylvania Clinical Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: CRI Worldwide, LLC
state: Pennsylvania
city: Red Lion
country: United States
facility: Dairyland Medical Center
state: Pennsylvania
city: Cranston
country: United States
facility: New England Center for Clinical Research, Inc
state: Rhode Island
city: Anderson
country: United States
facility: Hartwell Research Group, LLC
state: South Carolina
city: Greenville
country: United States
facility: Greenville Pharmaceutical Research, Inc.
state: South Carolina
city: Greer
country: United States
facility: Internal Medicine of Greer
state: South Carolina
city: Dakota Dunes
country: United States
facility: Meridian Clinical Research
state: South Dakota
city: Rapid City
country: United States
facility: Health Concepts Wellness Center
state: South Dakota
city: Huntingdon
country: United States
facility: Integrity Clinical Research, LLC
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Austin
country: United States
facility: Austin Center for Clinical Research
state: Texas
city: Corpus Christi
country: United States
facility: Corpus Christi Pain Medicine
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas
state: Texas
city: Houston
country: United States
facility: Pineloch Medical Clinic
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: Houston
country: United States
facility: Southwest Clinical Trials
state: Texas
city: Hurst
country: United States
facility: Protenium Clinical Research, LLC
state: Texas
city: Killeen
country: United States
facility: TEAM Research of Central Texas
state: Texas
city: San Angelo
country: United States
facility: West Texas Medical Associates
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: Bountiful
country: United States
facility: Research Facility
state: Utah
city: Murray
country: United States
facility: Summit Pain Management
state: Utah
city: Salt Lake City
country: United States
facility: Alpine Medical Group
state: Utah
city: Salt Lake City
country: United States
facility: Highland Clinical Research
state: Utah
city: Midlothian
country: United States
facility: Virginia Research Center
state: Virginia
city: Virginia Beach
country: United States
facility: Hilltop Medical Center
state: Virginia
city: Virginia Beach
country: United States
facility: Independence Family Medicine
state: Virginia
city: Tacoma
country: United States
facility: Universal Research Group
state: Washington
Study officials:
References: