Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) for Uncontrolled Moderate - Severe Low Back Pain

NCT01427270 | Completed Phase 3

• 2 other identifiers: ONU37042011-005060-26
• Study Type: interventional
• Target: 455
• Locations: 4 countries
• Sites: 194

Brief Summary

The primary objective is to assess the efficacy of oxycodone/naloxone (OXN) for the management of opioid-induced constipation (OIC) compared to oxycodone controlled-release tablets (OXY) in subjects with moderate to severe low back pain and OIC who require around-the-clock opioid therapy.

Conditions

Low Back Pain

Keywords

Low back pain; Chronic pain; Opioid; Constipation; Moderate to severe chronic low back pain

Outcome Measures

Primary Outcomes (1)

• Overall complete spontaneous bowel movement (CSBM) responder rates

  The overall Complete Spontaneous Bowel Movement (CSBM) responder rates over the 12 week double-blind period comparing OXN to OXY

  Weeks 1 through 12

Secondary Outcomes (2)

• CSBM Responder at least 50% of the weeks in the double-blind period

  Weeks 1 through 12

• Laxative-free Responder at least 50% of the weeks in the double-blind period

  Weeks 1 through 12

Study Arms (3)

OXN

EXPERIMENTAL

Oxycodone/Naloxone controlled-release tablets (OXN)

Drug: Oxycodone/Naloxone controlled-release

OXY

ACTIVE COMPARATOR

Oxycodone HCl controlled-release tablets (OXY)

Drug: Oxycodone HCl controlled-release

Placebo

PLACEBO COMPARATOR

Placebo tablets to match OXN or OXY

Drug: Placebo

Interventions

Oxycodone/Naloxone controlled-release DRUG

Oxycodone/Naloxone controlled-release tablets (10/5 - 40/20 mg) taken orally every 12 hours

OXN

Oxycodone HCl controlled-release DRUG

Oxycodone HCl controlled-release tablets (10 - 40 mg) taken orally every 12 hours

Also known as: OxyContin

OXY

Placebo DRUG

Placebo tablets to match OXN or OXY taken orally every 12 hours

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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).

You may not qualify if:

• Subjects with rheumatoid arthritis or other inflammatory arthritis;
• 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 the past 2 years, with the exception of basal cell carcinoma that has been successfully treated.

Sponsors & Collaborators

• Purdue Pharma LP: lead

Study Sites (194)

Investigational Site

Alabaster, Alabama, 35007, United States

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Birmingham, Alabama, 35242, United States

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Gulf Shores, Alabama, 36542, United States

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Homewood, Alabama, 35209, United States

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Huntsville, Alabama, 35801, United States

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Mobile, Alabama, 36608, United States

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Goodyear, Arizona, 85395-2511, United States

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Goodyear, Arizona, 85395, United States

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Phoenix, Arizona, 85018, United States

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Phoenix, Arizona, 85027, United States

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Tempe, Arizona, 85282, United States

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Tucson, Arizona, 85704, United States

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Hot Springs, Arkansas, 71901, United States

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Little Rock, Arkansas, 72211, United States

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Anaheim, California, 92801, United States

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Anaheim, California, 92804, United States

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Anaheim, California, 92805, United States

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Chino, California, 91710, United States

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Fresno, California, 93720, United States

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Fresno, California, 93726, United States

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Glendale, California, 91206, United States

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La Mesa, California, 91942, United States

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Laguna Hills, California, 92637, United States

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Long Beach, California, 90806, United States

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Los Angeles, California, 90017, United States

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Los Angeles, California, 90025, United States

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Los Angeles, California, 90036, United States

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Los Gatos, California, 95032, United States

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National City, California, 91950, United States

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North Hollywood, California, 91606, United States

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Oceanside, California, 92056, United States

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Paramount, California, 90723, United States

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Richmond, California, 94806, United States

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Roseville, California, 95661, United States

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Sacramento, California, 95823, United States

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Sacramento, California, 95842, United States

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San Diego, California, 92114, United States

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Santa Ana, California, 92701, United States

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Santa Clarita, California, 91350, United States

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Valley Village, California, 91607, United States

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Golden, Colorado, 80401, United States

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New Haven, Connecticut, 06511, United States

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Waterbury, Connecticut, 06708, United States

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Aventura, Florida, 33180, United States

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Boynton Beach, Florida, 33472, United States

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Bradenton, Florida, 34209, United States

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Clearwater, Florida, 33765, United States

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Clermont, Florida, 34711, United States

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Coral Gables, Florida, 33134, United States

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Daytona Beach, Florida, 32117, United States

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Fort Lauderdale, Florida, 33316, United States

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Hialeah, Florida, 33012, United States

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Hialeah, Florida, 33013, United States

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Inverness, Florida, 34452, United States

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Jacksonville, Florida, 32216, United States

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Jacksonville, Florida, 32257, United States

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Jupiter, Florida, 33458, United States

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Miami, Florida, 33125, United States

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Miami, Florida, 33126, United States

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Miami, Florida, 33135, United States

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Miami, Florida, 33143, United States

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Miami, Florida, 33185, United States

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Miami Lakes, Florida, 33014, United States

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Naples, Florida, 34110, United States

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Naples, Florida, 34113, United States

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New Port Richey, Florida, 34652, United States

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North Miami Beach, Florida, 33162, United States

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Orlando, Florida, 32806, United States

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Oviedo, Florida, 32765, United States

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Pinellas Park, Florida, 33781, United States

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Pinellas Park, Florida, 33782, United States

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Plantation, Florida, 33317, United States

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Port Orange, Florida, 32129, United States

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Sanford, Florida, 32771, United States

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South Miami, Florida, 33143, United States

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Tamarac, Florida, 33321, United States

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Tampa, Florida, 33607, United States

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Tampa, Florida, 33613, United States

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Wellington, Florida, 33414, United States

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Austell, Georgia, 30106, United States

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Blue Ridge, Georgia, 30513, United States

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Canton, Georgia, 30114, United States

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Columbus, Georgia, 31904, United States

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Johns Creek, Georgia, 30097, United States

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Marietta, Georgia, 30060, United States

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Perry, Georgia, 31069, United States

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Savannah, Georgia, 31405, United States

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Boise, Idaho, 83702, United States

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Meridian, Idaho, 83642, United States

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Bloomington, Illinois, 61701, United States

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Chicago, Illinois, 60657, United States

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Evansville, Indiana, 47714, United States

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Kansas City, Kansas, 66160, United States

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Wichita, Kansas, 67203, United States

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Lexington, Kentucky, 40504, United States

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Madisonville, Kentucky, 42431, United States

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Baton Rouge, Louisiana, 70809, United States

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Covington, Louisiana, 70435, United States

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Marrero, Louisiana, 70072, United States

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Metairie, Louisiana, 70006, United States

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Hollywood, Maryland, 20636, United States

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Fall River, Massachusetts, 02720, United States

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North Attleboro, Massachusetts, 02760, United States

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Bay City, Michigan, 48706, United States

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Pinconning, Michigan, 48650, United States

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Rochester, Michigan, 48307, United States

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Troy, Michigan, 48085, United States

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Hazelwood, Missouri, 63042, United States

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St Louis, Missouri, 63128, United States

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St Louis, Missouri, 63141, United States

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Las Vegas, Nevada, 89119, United States

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Stratford, New Jersey, 08084, United States

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Toms River, New Jersey, 08755, United States

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Voorhees Township, New Jersey, 08034, United States

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Albuquerque, New Mexico, 87106, United States

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Cedarhurst, New York, 11516, United States

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Great Neck, New York, 11023, United States

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New Windsor, New York, 12553, United States

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New York, New York, 10022, United States

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North Massapequa, New York, 11758, United States

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Williamsville, New York, 14221, United States

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Elkin, North Carolina, 28621, United States

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Winston-Salem, North Carolina, 27103, United States

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Beavercreek, Ohio, 45432, United States

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Cincinnati, Ohio, 45242, United States

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Cleveland, Ohio, 44122, United States

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Columbus, Ohio, 43210, United States

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Columbus, Ohio, 43214, United States

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Franklin, Ohio, 45005, United States

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Groveport, Ohio, 43125, United States

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Toledo, Ohio, 43623, United States

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Oklahoma City, Oklahoma, 73119, United States

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Altoona, Pennsylvania, 16602, United States

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Jenkintown, Pennsylvania, 19046, United States

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Johnstown, Pennsylvania, 15904, United States

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Philadelphia, Pennsylvania, 19152, United States

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Phoenixville, Pennsylvania, 19460, United States

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Tipton, Pennsylvania, 16684, United States

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Warwick, Rhode Island, 02886, United States

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Myrtle Beach, South Carolina, 29588, United States

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Spartanburg, South Carolina, 29303, United States

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Franklin, Tennessee, 37067, United States

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New Tazewell, Tennessee, 37825, United States

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Arlington, Texas, 76011, United States

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Athens, Texas, 75751, United States

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Austin, Texas, 78756, United States

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Dallas, Texas, 75231, United States

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Dallas, Texas, 75251, United States

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Houston, Texas, 77005, United States

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Houston, Texas, 77024, United States

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Houston, Texas, 77025, United States

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Houston, Texas, 77030, United States

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Houston, Texas, 77057, United States

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Houston, Texas, 77065, United States

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Houston, Texas, 77074, United States

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Houston, Texas, 77098, United States

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Humble, Texas, 77338, United States

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North Richland Hills, Texas, 76180, United States

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Plano, Texas, 75075, United States

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San Antonio, Texas, 78229, United States

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San Antonio, Texas, 78238, United States

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Sugar Land, Texas, 77478, United States

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Tomball, Texas, 77375, United States

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Clinton, Utah, 84015, United States

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Salt Lake City, Utah, 84102, United States

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Salt Lake City, Utah, 84107, United States

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West Jordan, Utah, 84088, United States

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Richmond, Virginia, 23220, United States

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Richmond, Virginia, 23235, United States

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Virginia Beach, Virginia, 23454, United States

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Brno, 656 91, Czechia

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Hradec Králové, 500 03, Czechia

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Most, 434 64, Czechia

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Olomouc, 775 20, Czechia

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Prague, 100 00, Czechia

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Prague, 160 00, Czechia

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Praha 4 - Krc, 140 59, Czechia

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Rychnov nad Kněžnou, 516 01, Czechia

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Sternberk, 785 01, Czechia

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Vysoké Mýto, 566 23, Czechia

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Zlín, 760 01, Czechia

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Znojmo, 669 02, Czechia

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Catania, 95123, Italy

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Bielsko-Biala, 43-300, Poland

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Bydgoszcz, 85-079, Poland

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Bydgoszcz, 85-796, Poland

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Gdansk, 80-286, Poland

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Gdansk, 80-546, Poland

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Gdynia, 81-366, Poland

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Katowice, 40-084, Poland

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Katowice, 40-683, Poland

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Lublin, 20-582, Poland

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Lublin, 20-718, Poland

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Torun, 87-100, Poland

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MeSH Terms

Conditions

Low Back Pain; Chronic Pain; Constipation

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2011
• First Posted: September 1, 2011
• Study Start: August 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 7, 2014

Record last verified: 2014-11

Locations

US (170); IT (1); PL (11); CZ (12)