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Low Back PainPhase 3NCT01358526

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

A Phase 3 study of Low Back Pain, run by Purdue Pharma LP at 151 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Low Back Pain
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,095 participants
Where
151 sitesUnited States
Study dates
May 2011to Nov 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

151 sites in 1 country.

151 sites in 1 country

United States151 sites

  • Allegheny Pain Management, PC

    Altoona, Pennsylvania, 16602

  • Orange County Research Institute

    Anaheim, California, 92801

  • Physician Alliance Research Center

    Anaheim, California, 92804

  • Hartwell Research Group, LLC

    Anderson, South Carolina, 29621

  • Advanced Pain Research Institute

    Arcadia, California, 91007

  • Independent Neurodiagnostic Clinic

    Atlanta, Georgia, 30327

  • FutureSearch Trials of Neurology

    Austin, Texas, 78731

  • Austin Center for Clinical Research

    Austin, Texas, 78756

  • Great Lakes Research Group, Inc.

    Bay City, Michigan, 48706

  • Clinical Inquest Center Ltd.

    Beavercreek, Ohio, 45432

  • Bend Memorial Clinic

    Bend, Oregon, 97701

  • Alabama Orthopaedic Center, PC

    Birmingham, Alabama, 35209

  • Alliance Clinical Research

    Birmingham, Alabama, 35213

  • South Jersey Medical Associates, P.A.

    Blackwood, New Jersey, 08012

  • The Pain Center

    Boise, Idaho, 83702

  • Research Facility

    Bountiful, Utah, 84010

  • Orthopedic Research Institute

    Boynton Beach, Florida, 33472

  • Coastal Orthopedics & Pain Management

    Bradenton, Florida, 34208

  • Paramount Clinical Research

    Bridgeville, Pennsylvania, 15017

  • Beacon Clinical Research, LLC

    Brockton, Massachusetts, 02301

  • Southbay Pharma Research

    Buena Park, California, 90620

  • Providence Clinical Research

    Burbank, California, 91505

  • Great Lakes Family Care

    Cadillac, Michigan, 49601

  • Med Center

    Carmichael, California, 95608

  • Advanced Pain Management and Rehabilitation Medical Group, Inc.

    Castro Valley, California, 94546

  • Five Towns Neuroscience Research/Five Towns Neurology

    Cedarhurst, New York, 11516

  • Radiant Research, Inc.

    Chandler, Arizona, 85224

  • Gaffney Health Services

    Charlotte, North Carolina, 28205

  • Box Arthritis & Rheumatology of the Carolinas, PLLC

    Charlotte, North Carolina, 28210

  • Southeast Clinical Research, LLC

    Chiefland, Florida, 32626

  • Catalina Research Institute, LLC

    Chino, California, 91710

  • Community Research

    Cincinnati, Ohio, 45227

  • Innovative Research of West Florida, Inc.

    Clearwater, Florida, 33756

  • Clinical Research of West Florida, Inc.

    Clearwater, Florida, 33765

  • Columbus Clinical Research, Inc.

    Columbus, Ohio, 43213

  • Corpus Christi Pain Medicine

    Corpus Christi, Texas, 78415

  • New England Center for Clinical Research, Inc

    Cranston, Rhode Island, 02920

  • Meridian Clinical Research

    Dakota Dunes, South Dakota, 57049

  • FutureSearch Trials of Dallas

    Dallas, Texas, 75231

  • Hometown Urgent Care and Research

    Dayton, Ohio, 45432

  • Omega Research Consultants, LLC

    DeBary, Florida, 32713

  • Denver Internal Medicine Group

    Denver, Colorado, 80209

  • In-Quest Medical Research, LLC

    Duluth, Georgia, 30096

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • Synergy Clinical Research of Escondido

    Escondido, California, 92025

  • Pain Consultants of Oregon

    Eugene, Oregon, 97401

  • Willamette Valley Clinical Studies

    Eugene, Oregon, 97404

  • Destiny Clinical Research, LLC

    Evansville, Indiana, 47714

  • MediSphere Medical Research Center, LLC

    Evansville, Indiana, 47714

  • Plains Medical Clinic, LLC

    Fargo, North Dakota, 58104

  • S & W Clinical Research

    Fort Lauderdale, Florida, 33306

  • Prestige Clinical Research

    Franklin, Ohio, 45005

  • Valley Research

    Fresno, California, 93720

  • Southeastern Integrated Medical, PL

    Gainesville, Florida, 32607

  • RX Clinical Research, Inc.

    Garden Grove, California, 92843

  • Long Island Gastrointestinal Research Group, LLP

    Great Neck, New York, 11023

  • PharmQuest

    Greensboro, North Carolina, 27408

  • Greenville Pharmaceutical Research, Inc.

    Greenville, South Carolina, 29615

  • Internal Medicine of Greer

    Greer, South Carolina, 29650

  • Clinical Investigation Specialists, Inc.

    Gurnee, Illinois, 60031

  • Winston Technology Research, LLC

    Haleyville, Alabama, 35565

  • ActivMed Practices and Research

    Haverhill, Massachusetts, 01830

  • Health Care Family Rehab & Research Center

    Hialeah, Florida, 33012

  • Eastern Research, Inc.

    Hialeah, Florida, 33013

  • Peters Medical Research

    High Point, North Carolina, 27262

  • Mid-Atlantic Medical Research Centers

    Hollywood, Maryland, 20636

  • Pineloch Medical Clinic

    Houston, Texas, 77062

  • Clinical Trial Network

    Houston, Texas, 77074

  • Southwest Clinical Trials

    Houston, Texas, 77074

  • Integrity Clinical Research, LLC

    Huntingdon, Tennessee, 38344

  • Monte Sano Clinical Research, LLC

    Huntsville, Alabama, 35801

  • Protenium Clinical Research, LLC

    Hurst, Texas, 76054

  • Southeast Clinical Research, LLC

    Jacksonville, Florida, 32216

  • Florida Institute of Medical Research

    Jacksonville, Florida, 32257

  • The Clinical Trial Center, LLC

    Jenkintown, Pennsylvania, 19046

  • Drug Study Institute

    Jupiter, Florida, 33458

  • TEAM Research of Central Texas

    Killeen, Texas, 76543

  • TriWest Research Associates

    La Mesa, California, 91942

  • Pacific Coast Pain Management Center

    Laguna Hills, California, 92637

  • South Orange County Surgical Medical Group

    Laguna Hills, California, 92653

  • Research Facility

    Las Vegas, Nevada, 89109

  • International Clinical Research Institute, Inc.

    Leawood, Kansas, 66211

  • The Pain Treatment Center of the Bluegrass

    Lexington, Kentucky, 40503

  • Clinical Trials Research

    Lincoln, California, 95648

  • Ortho Surgeons

    Little Rock, Arkansas, 72205

  • L.A. Pain and Wellness Institute

    Los Angeles, California, 90017

  • Georgia Institute for Clinical Research, LLC

    Marietta, Georgia, 30060

  • Research Facility

    Marietta, Georgia, 30060

  • Central Pennsylvania Clinical Research

    Mechanicsburg, Pennsylvania, 17055

  • Sunstone Medical Research, LLC

    Medford, Oregon, 97504

  • Pharma Care Research, Inc.

    Miami, Florida, 33144

  • Advanced Pharma CR, LLC

    Miami, Florida, 33175

  • Virginia Research Center

    Midlothian, Virginia, 23114

  • Research Facility

    Mobile, Alabama, 36608

  • Summit Pain Management

    Murray, Utah, 84107

  • Louisiana Research Associates, Inc.

    New Orleans, Louisiana, 70114

  • Research Facility

    New Orleans, Louisiana, 70115

  • Medex Healthcare Research, Inc.

    New York, New York, 10022

  • Research Across America

    New York, New York, 10022

  • Better Health Clinical Research, Inc.

    Newnan, Georgia, 30265

  • Newport Beach Clinical Research Associates, Inc.

    Newport Beach, California, 92663

  • Neuropsychiatric Center and NPC Research

    Oklahoma City, Oklahoma, 73109-3834

  • Health Research Institute

    Oklahoma City, Oklahoma, 73109

  • Paradigm Research Professionals, LLC

    Oklahoma City, Oklahoma, 73112

  • Meridian Clinical Research, LLC

    Omaha, Nebraska, 68134

  • Compass Research, LLC

    Orlando, Florida, 32806

  • Peninsula Research, Inc.

    Ormond Beach, Florida, 32174

  • Lotus Clinical Research

    Pasadena, California, 91105

  • CRI Worldwide, LLC

    Philadelphia, Pennsylvania, 19139

  • Dedicated Clinical Research

    Phoenix, Arizona, 85020

  • Arizona Research Center

    Phoenix, Arizona, 85023

  • Clinical Research Advantage, Inc./Tatum Highlands Medical Associates, PLLC

    Phoenix, Arizona, 85050

  • MidAtlantic Pain Medicine Center

    Pikesville, Maryland, 21208

  • Great Lakes Research Group, Inc.

    Pinconning, Michigan, 48650

  • Clinical Trials Technology, Inc. CTT Consultants, Inc.

    Prairie Village, Kansas, 66206

  • Health Concepts Wellness Center

    Rapid City, South Dakota, 57702

  • Dairyland Medical Center

    Red Lion, Pennsylvania, 17356

  • Northern California Clinical Research Center

    Redding, California, 96001

  • Probe Clinical Research Corporation

    Riverside, California, 92501

  • Northern California Research

    Sacramento, California, 95821

  • Alpine Medical Group

    Salt Lake City, Utah, 84102

  • Highland Clinical Research

    Salt Lake City, Utah, 84124

  • West Texas Medical Associates

    San Angelo, Texas, 76904

  • Sun Research Institute

    San Antonio, Texas, 78215

  • Probe Clinical Research Corporation

    Santa Ana, California, 92701

  • Sarasota Clinical Research, LLC

    Sarasota, Florida, 34232

  • Sarasota Pain Medicine Research

    Sarasota, Florida, 34238

  • SouthCoast Medical Group

    Savannah, Georgia, 31406

  • Georgia Clinical Research, LLC

    Snellville, Georgia, 30078

  • Hometown Urgent Care and Research

    Springfield, Ohio, 45504

  • Medex Healthcare Research, Inc.

    St Louis, Missouri, 63117

  • Mercy Health Research

    St Louis, Missouri, 63141

  • Sundance Clinical Research, LLC

    St Louis, Missouri, 63141

  • University of Medicine & Dentistry of New Jersey - School of Osteopathic Medicine (UMDNJ)

    Stratford, New Jersey, 08084

  • Universal Research Group

    Tacoma, Washington, 98405

  • Vita Research Solutions & Medical Center, Inc.

    Tamarac, Florida, 33319

  • Stedman Clinical Trials

    Tampa, Florida, 33613

  • J L Clinical Research

    Tiffin, Ohio, 44883

  • Bone Joint and Spine Surgeons, Inc.

    Toledo, Ohio, 43623

  • Advanced Research Institute, Inc.

    Trinity, Florida, 34655

  • New England Research Associates, LLC

    Trumbull, Connecticut, 06611

  • Quality of Life Medical & Research Center, LLC

    Tucson, Arizona, 85712

  • Northwest Indiana Center for Clinical Research

    Valparaiso, Indiana, 46383

  • Hilltop Medical Center

    Virginia Beach, Virginia, 23454

  • Independence Family Medicine

    Virginia Beach, Virginia, 23455

  • Medvadis Research Corporation

    Watertown, Massachusetts, 02472-3930

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409

  • Front Range Clinical Research

    Wheat Ridge, Colorado, 80033

  • Upstate Clinical Research Associates, LLC

    Williamsville, New York, 14221

  • National Pain Research Institute, LLC

    Winter Park, Florida, 32789

  • Pharmacotherapy Research Associates, Inc.

    Zanesville, Ohio, 43701

Other trials in United States

About this study

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

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.

Conditions
Low Back Pain
Being tested
Oxycodone/Naloxone Controlled-release, Placebo
Keywords
Low back pain, Chronic pain, Opioid, Moderate to severe chronic low back pain
Medical subject headings
Low Back Pain, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oxycodone/Naloxone Controlled-releaseDrug

    Also called TARGINIQ ER

    Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours

  • PlaceboDrug

    Placebo tablets to match OXN taken orally every 12 hours

Study groups in NCT01358526
Study groupRoleWhat they receive
OXNExperimentalOxycodone/Naloxone Controlled-release Tablets (OXN)
Receives: Drug: Oxycodone/Naloxone Controlled-release
PlaceboPlacebo comparatorPlacebo tablets to match OXN
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 24 hours (Week 12)

Secondary outcomes (2)

  1. 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.

    Measured: Weeks 4, 8, and 12

  2. 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.

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionOct 2012
  4. Study completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,095 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01358526
Sponsor's protocol ID
ONU3701
Status last verified
Oct 2015
First submitted
20 May 2011
Last updated
11 Nov 2015
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study of Low Back Pain, run by Purdue Pharma LP at 151 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 151 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The "Average Pain Over the Last 24 Hours" at Week 12 of the Double-blind Period (time frame: 24 hours (Week 12)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01358526.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2015.

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