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
NCT ID: NCT01427283
Last Updated: 2015-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
450 participants
INTERVENTIONAL
2011-08-31
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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OXN
Oxycodone/Naloxone controlled-release tablets (OXN)
Oxycodone/Naloxone controlled-release
Oxycodone/Naloxone controlled-release tablets (10/5 - 40/20 mg) taken orally every 12 hours
OXY
Oxycodone HCl controlled-release tablets (OXY)
Oxycodone HCl controlled-release
Oxycodone HCl controlled-release tablets (10 - 40 mg) taken orally every 12 hours
Placebo
Placebo tablets to match OXN or OXY
Placebo
Placebo tablets to match OXN or OXY taken orally every 12 hours
Interventions
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Oxycodone/Naloxone controlled-release
Oxycodone/Naloxone controlled-release tablets (10/5 - 40/20 mg) taken orally every 12 hours
Oxycodone HCl controlled-release
Oxycodone HCl controlled-release tablets (10 - 40 mg) taken orally every 12 hours
Placebo
Placebo tablets to match OXN or OXY taken orally every 12 hours
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Purdue Pharma LP
INDUSTRY
Responsible Party
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Locations
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Investigational Site
Alabaster, Alabama, United States
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Foley, Alabama, United States
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Mobile, Alabama, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Sun Lakes, Arizona, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Sherwood, Arkansas, United States
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Anaheim, California, United States
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Anaheim, California, United States
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Artesia, California, United States
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Cerritos, California, United States
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Chino, California, United States
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El Cajon, California, United States
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Encino, California, United States
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Fountain Valley, California, United States
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Fresno, California, United States
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Garden Grove, California, United States
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Garden Grove, California, United States
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Laguna Hills, California, United States
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Lakewood, California, United States
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Lincoln, California, United States
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Lomita, California, United States
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Long Beach, California, United States
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Oceanside, California, United States
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Orange, California, United States
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Paramount, California, United States
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Sacramento, California, United States
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San Bernardino, California, United States
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San Diego, California, United States
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San Diego, California, United States
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Thousand Oaks, California, United States
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Torrance, California, United States
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Colorado Springs, Colorado, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Golden, Colorado, United States
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Aventura, Florida, United States
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Bradenton, Florida, United States
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Chiefland, Florida, United States
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Clermont, Florida, United States
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Daytona Beach, Florida, United States
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DeLand, Florida, United States
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Edgewater, Florida, United States
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Fort Lauderdale, Florida, United States
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Fort Myers, Florida, United States
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Hialeah, Florida, United States
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Hialeah, Florida, United States
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Inverness, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami Beach, Florida, United States
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Naples, Florida, United States
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Naples, Florida, United States
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New Smyrna Beach, Florida, United States
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North Miami, Florida, United States
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Oldsmar, Florida, United States
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Orlando, Florida, United States
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Oviedo, Florida, United States
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Plantation, Florida, United States
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Tamarac, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Austell, Georgia, United States
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Snellville, Georgia, United States
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Boise, Idaho, United States
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Boise, Idaho, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Chicago, Illinois, United States
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Evansville, Indiana, United States
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Indianapolis, Indiana, United States
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Michigan City, Indiana, United States
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Wichita, Kansas, United States
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Edgewood, Kentucky, United States
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Lake Charles, Louisiana, United States
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Monroe, Louisiana, United States
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New Orleans, Louisiana, United States
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Pikesville, Maryland, United States
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Brockton, Massachusetts, United States
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Worcester, Massachusetts, United States
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Florissant, Missouri, United States
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Las Vegas, Nevada, United States
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Atco, New Jersey, United States
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Great Neck, New York, United States
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Kew Gardens, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Williamsville, New York, United States
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Durham, North Carolina, United States
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Elkin, North Carolina, United States
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High Point, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Moraine, Ohio, United States
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Toledo, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Eugene, Oregon, United States
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Jenkintown, Pennsylvania, United States
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Levittown, Pennsylvania, United States
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Mechanicsburg, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Red Lion, Pennsylvania, United States
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State College, Pennsylvania, United States
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Warwick, Rhode Island, United States
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Charleston, South Carolina, United States
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Myrtle Beach, South Carolina, United States
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Rapid City, South Dakota, United States
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Jackson, Tennessee, United States
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Allen, Texas, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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McKinney, Texas, United States
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North Richland Hills, Texas, United States
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Tomball, Texas, United States
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Orem, Utah, United States
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Salt Lake City, Utah, United States
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Salt Lake City, Utah, United States
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Danville, Virginia, United States
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Midlothian, Virginia, United States
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Richmond, Virginia, United States
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Bothell, Washington, United States
Countries
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Other Identifiers
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2011-005061-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ONU3705
Identifier Type: -
Identifier Source: org_study_id
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