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

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01358526
• Other study ID #: ONU3701
• Status: Completed
• Phase: Phase 3
• First received: May 20, 2011
• Last updated: October 14, 2015
• Start date: May 2011
• Est. completion date: November 2012

Study information

• Verified date: October 2015
• Source: Purdue Pharma LP
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1095
• Est. completion date: November 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 [ß 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Drug:
• Oxycodone/Naloxone Controlled-release
Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours
• Placebo
Placebo tablets to match OXN taken orally every 12 hours

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Purdue Pharma LP

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Responder Analysis for Subjects With a = 30% Reduction in Pain Compared to Baseline	A subject's response to treatment was defined as the percentage reduction from the screening mean pain score to the "average pain over the last 24 hours" score for week 12 of the double-blind period.	Week 12	No
Other	Responder Analysis for Subjects With a = 50% Reduction in Pain Compared to Baseline	A subject's response to treatment was defined as the percentage reduction from the screening mean pain score to the "average pain over the last 24 hours" score for week 12 of the double-blind period.	Week 12	No
Primary	The "Average Pain Over the Last 24 Hours" at Week 12 of the Double-blind Period	The "average pain over the last 24 hours" score was collected using an 11-point numerical rating scale ranging from 0 to 10; where 0=no pain and 10=pain as bad as you can imagine.	24 hours (Week 12)	No
Secondary	The Sleep Disturbance Subscale of the MOS Sleep Scale at Weeks 4, 8, and 12	The scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of sleep, 3 somnolence, 1 snoring, 1 shortness of breath). Only Sleep Disturbance Subscale questions 1, 3, 7, and 8 were analyzed; scores range from 0 to 100, where higher scores indicate greater sleep disturbance.	Weeks 4, 8, and 12	No
Secondary	Patient Global Impression of Change (PGIC)	The PGIC observational scale was completed by the subject. Subjects were asked to assess the change in overall status relative to the start of the study. The scale has only 1 item, which measures global change of overall status by the subject on a 7-point scale (Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse), where 1 = very much improved and 7 = very much worse. The proportion of subjects responding "much improved" and "very much improved" was summarized by treatment group and compared between groups using an exact test.	Week 12	No

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