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 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

Sponsors

Lead Sponsor: Purdue Pharma LP

Source Purdue Pharma LP
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.

Overall Status Completed
Start Date May 2011
Completion Date November 2012
Primary Completion Date October 2012
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
The "Average Pain Over the Last 24 Hours" at Week 12 of the Double-blind Period 24 hours (Week 12)
Secondary Outcome
Measure Time Frame
The Sleep Disturbance Subscale of the MOS Sleep Scale at Weeks 4, 8, and 12 Weeks 4, 8, and 12
Patient Global Impression of Change (PGIC) Week 12
Enrollment 1095
Condition
Intervention

Intervention Type: Drug

Intervention Name: Oxycodone/Naloxone Controlled-release

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

Arm Group Label: OXN

Other Name: TARGINIQ ER

Intervention Type: Drug

Intervention Name: Placebo

Description: Placebo tablets to match OXN taken orally every 12 hours

Arm Group Label: Placebo

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility:
Alabama Orthopaedic Center, PC | Birmingham, Alabama, 35209, United States
Alliance Clinical Research | Birmingham, Alabama, 35213, United States
Winston Technology Research, LLC | Haleyville, Alabama, 35565, United States
Monte Sano Clinical Research, LLC | Huntsville, Alabama, 35801, United States
Research Facility | Mobile, Alabama, 36608, United States
Radiant Research, Inc. | Chandler, Arizona, 85224, United States
Dedicated Clinical Research | Phoenix, Arizona, 85020, United States
Arizona Research Center | Phoenix, Arizona, 85023, United States
Clinical Research Advantage, Inc./Tatum Highlands Medical Associates, PLLC | Phoenix, Arizona, 85050, United States
Quality of Life Medical & Research Center, LLC | Tucson, Arizona, 85712, United States
Ortho Surgeons | Little Rock, Arkansas, 72205, United States
Orange County Research Institute | Anaheim, California, 92801, United States
Physician Alliance Research Center | Anaheim, California, 92804, United States
Advanced Pain Research Institute | Arcadia, California, 91007, United States
Southbay Pharma Research | Buena Park, California, 90620, United States
Providence Clinical Research | Burbank, California, 91505, United States
Med Center | Carmichael, California, 95608, United States
Advanced Pain Management and Rehabilitation Medical Group, Inc. | Castro Valley, California, 94546, United States
Catalina Research Institute, LLC | Chino, California, 91710, United States
Synergy Clinical Research of Escondido | Escondido, California, 92025, United States
Valley Research | Fresno, California, 93720, United States
RX Clinical Research, Inc. | Garden Grove, California, 92843, United States
TriWest Research Associates | La Mesa, California, 91942, United States
Pacific Coast Pain Management Center | Laguna Hills, California, 92637, United States
South Orange County Surgical Medical Group | Laguna Hills, California, 92653, United States
Clinical Trials Research | Lincoln, California, 95648, United States
L.A. Pain and Wellness Institute | Los Angeles, California, 90017, United States
Newport Beach Clinical Research Associates, Inc. | Newport Beach, California, 92663, United States
Lotus Clinical Research | Pasadena, California, 91105, United States
Northern California Clinical Research Center | Redding, California, 96001, United States
Probe Clinical Research Corporation | Riverside, California, 92501, United States
Northern California Research | Sacramento, California, 95821, United States
Probe Clinical Research Corporation | Santa Ana, California, 92701, United States
Denver Internal Medicine Group | Denver, Colorado, 80209, United States
Front Range Clinical Research | Wheat Ridge, Colorado, 80033, United States
New England Research Associates, LLC | Trumbull, Connecticut, 06611, United States
Orthopedic Research Institute | Boynton Beach, Florida, 33472, United States
Coastal Orthopedics & Pain Management | Bradenton, Florida, 34208, United States
Southeast Clinical Research, LLC | Chiefland, Florida, 32626, United States
Innovative Research of West Florida, Inc. | Clearwater, Florida, 33756, United States
Clinical Research of West Florida, Inc. | Clearwater, Florida, 33765, United States
Omega Research Consultants, LLC | Debary, Florida, 32713, United States
S & W Clinical Research | Fort Lauderdale, Florida, 33306, United States
Southeastern Integrated Medical, PL | Gainesville, Florida, 32607, United States
Health Care Family Rehab & Research Center | Hialeah, Florida, 33012, United States
Eastern Research, Inc. | Hialeah, Florida, 33013, United States
Southeast Clinical Research, LLC | Jacksonville, Florida, 32216, United States
Florida Institute of Medical Research | Jacksonville, Florida, 32257, United States
Drug Study Institute | Jupiter, Florida, 33458, United States
Pharma Care Research, Inc. | Miami, Florida, 33144, United States
Advanced Pharma CR, LLC | Miami, Florida, 33175, United States
Compass Research, LLC | Orlando, Florida, 32806, United States
Peninsula Research, Inc. | Ormond Beach, Florida, 32174, United States
Sarasota Clinical Research, LLC | Sarasota, Florida, 34232, United States
Sarasota Pain Medicine Research | Sarasota, Florida, 34238, United States
Vita Research Solutions & Medical Center, Inc. | Tamarac, Florida, 33319, United States
Stedman Clinical Trials | Tampa, Florida, 33613, United States
Advanced Research Institute, Inc. | Trinity, Florida, 34655, United States
Palm Beach Research Center | West Palm Beach, Florida, 33409, United States
National Pain Research Institute, LLC | Winter Park, Florida, 32789, United States
Independent Neurodiagnostic Clinic | Atlanta, Georgia, 30327, United States
In-Quest Medical Research, LLC | Duluth, Georgia, 30096, United States
Georgia Institute for Clinical Research, LLC | Marietta, Georgia, 30060, United States
Research Facility | Marietta, Georgia, 30060, United States
Better Health Clinical Research, Inc. | Newnan, Georgia, 30265, United States
SouthCoast Medical Group | Savannah, Georgia, 31406, United States
Georgia Clinical Research, LLC | Snellville, Georgia, 30078, United States
The Pain Center | Boise, Idaho, 83702, United States
Clinical Investigation Specialists, Inc. | Gurnee, Illinois, 60031, United States
Destiny Clinical Research, LLC | Evansville, Indiana, 47714, United States
MediSphere Medical Research Center, LLC | Evansville, Indiana, 47714, United States
Northwest Indiana Center for Clinical Research | Valparaiso, Indiana, 46383, United States
International Clinical Research Institute, Inc. | Leawood, Kansas, 66211, United States
Clinical Trials Technology, Inc. CTT Consultants, Inc. | Prairie Village, Kansas, 66206, United States
The Pain Treatment Center of the Bluegrass | Lexington, Kentucky, 40503, United States
Louisiana Research Associates, Inc. | New Orleans, Louisiana, 70114, United States
Research Facility | New Orleans, Louisiana, 70115, United States
Mid-Atlantic Medical Research Centers | Hollywood, Maryland, 20636, United States
MidAtlantic Pain Medicine Center | Pikesville, Maryland, 21208, United States
Beacon Clinical Research, LLC | Brockton, Massachusetts, 02301, United States
ActivMed Practices and Research | Haverhill, Massachusetts, 01830, United States
Medvadis Research Corporation | Watertown, Massachusetts, 02472-3930, United States
Great Lakes Research Group, Inc. | Bay City, Michigan, 48706, United States
Great Lakes Family Care | Cadillac, Michigan, 49601, United States
Great Lakes Research Group, Inc. | Pinconning, Michigan, 48650, United States
Medex Healthcare Research, Inc. | Saint Louis, Missouri, 63117, United States
Mercy Health Research | St. Louis, Missouri, 63141, United States
Sundance Clinical Research, LLC | St. Louis, Missouri, 63141, United States
Meridian Clinical Research, LLC | Omaha, Nebraska, 68134, United States
Research Facility | Las Vegas, Nevada, 89109, United States
South Jersey Medical Associates, P.A. | Blackwood, New Jersey, 08012, United States
University of Medicine & Dentistry of New Jersey - School of Osteopathic Medicine (UMDNJ) | Stratford, New Jersey, 08084, United States
Five Towns Neuroscience Research/Five Towns Neurology | Cedarhurst, New York, 11516, United States
Long Island Gastrointestinal Research Group, LLP | Great Neck, New York, 11023, United States
Medex Healthcare Research, Inc. | New York, New York, 10022, United States
Research Across America | New York, New York, 10022, United States
Upstate Clinical Research Associates, LLC | Williamsville, New York, 14221, United States
Gaffney Health Services | Charlotte, North Carolina, 28205, United States
Box Arthritis & Rheumatology of the Carolinas, PLLC | Charlotte, North Carolina, 28210, United States
PharmQuest | Greensboro, North Carolina, 27408, United States
Peters Medical Research | High Point, North Carolina, 27262, United States
Plains Medical Clinic, LLC | Fargo, North Dakota, 58104, United States
Clinical Inquest Center Ltd. | Beavercreek, Ohio, 45432, United States
Community Research | Cincinnati, Ohio, 45227, United States
Columbus Clinical Research, Inc. | Columbus, Ohio, 43213, United States
Hometown Urgent Care and Research | Dayton, Ohio, 45432, United States
Prestige Clinical Research | Franklin, Ohio, 45005, United States
Hometown Urgent Care and Research | Springfield, Ohio, 45504, United States
J L Clinical Research | Tiffin, Ohio, 44883, United States
Bone Joint and Spine Surgeons, Inc. | Toledo, Ohio, 43623, United States
Pharmacotherapy Research Associates, Inc. | Zanesville, Ohio, 43701, United States
Neuropsychiatric Center and NPC Research | Oklahoma City, Oklahoma, 73109-3834, United States
Health Research Institute | Oklahoma City, Oklahoma, 73109, United States
Paradigm Research Professionals, LLC | Oklahoma City, Oklahoma, 73112, United States
Bend Memorial Clinic | Bend, Oregon, 97701, United States
Pain Consultants of Oregon | Eugene, Oregon, 97401, United States
Willamette Valley Clinical Studies | Eugene, Oregon, 97404, United States
Sunstone Medical Research, LLC | Medford, Oregon, 97504, United States
Allegheny Pain Management, PC | Altoona, Pennsylvania, 16602, United States
Paramount Clinical Research | Bridgeville, Pennsylvania, 15017, United States
Altoona Center for Clinical Research | Duncansville, Pennsylvania, 16635, United States
The Clinical Trial Center, LLC | Jenkintown, Pennsylvania, 19046, United States
Central Pennsylvania Clinical Research | Mechanicsburg, Pennsylvania, 17055, United States
CRI Worldwide, LLC | Philadelphia, Pennsylvania, 19139, United States
Dairyland Medical Center | Red Lion, Pennsylvania, 17356, United States
New England Center for Clinical Research, Inc | Cranston, Rhode Island, 02920, United States
Hartwell Research Group, LLC | Anderson, South Carolina, 29621, United States
Greenville Pharmaceutical Research, Inc. | Greenville, South Carolina, 29615, United States
Internal Medicine of Greer | Greer, South Carolina, 29650, United States
Meridian Clinical Research | Dakota Dunes, South Dakota, 57049, United States
Health Concepts Wellness Center | Rapid City, South Dakota, 57702, United States
Integrity Clinical Research, LLC | Huntingdon, Tennessee, 38344, United States
FutureSearch Trials of Neurology | Austin, Texas, 78731, United States
Austin Center for Clinical Research | Austin, Texas, 78756, United States
Corpus Christi Pain Medicine | Corpus Christi, Texas, 78415, United States
FutureSearch Trials of Dallas | Dallas, Texas, 75231, United States
Pineloch Medical Clinic | Houston, Texas, 77062, United States
Clinical Trial Network | Houston, Texas, 77074, United States
Southwest Clinical Trials | Houston, Texas, 77074, United States
Protenium Clinical Research, LLC | Hurst, Texas, 76054, United States
TEAM Research of Central Texas | Killeen, Texas, 76543, United States
West Texas Medical Associates | San Angelo, Texas, 76904, United States
Sun Research Institute | San Antonio, Texas, 78215, United States
Research Facility | Bountiful, Utah, 84010, United States
Summit Pain Management | Murray, Utah, 84107, United States
Alpine Medical Group | Salt Lake City, Utah, 84102, United States
Highland Clinical Research | Salt Lake City, Utah, 84124, United States
Virginia Research Center | Midlothian, Virginia, 23114, United States
Hilltop Medical Center | Virginia Beach, Virginia, 23454, United States
Independence Family Medicine | Virginia Beach, Virginia, 23455, United States
Universal Research Group | Tacoma, Washington, 98405, United States
Location Countries

United States

Verification Date

October 2015

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: OXN

Type: Experimental

Description: Oxycodone/Naloxone Controlled-release Tablets (OXN)

Label: Placebo

Type: Placebo Comparator

Description: Placebo tablets to match OXN

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov