Low Back Pain Clinical Trial
Official title:
A Randomized, Double-blind, Double-dummy, Placebo-controlled, Active-controlled, Parallel-group, Multicenter Trial of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess the Analgesic Efficacy (Compared to Placebo) and the Management of Opioid-induced Constipation (Compared to Oxycodone Controlled-release Tablets (OXY)) in Opioid-experienced Subjects With Uncontrolled Moderate to Severe Chronic Low Back Pain and a History of Opioid-induced Constipation Who Require Around-the-clock Opioid Therapy
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.
| Status | Completed |
| Enrollment | 455 |
| Est. completion date | October 2014 |
| Est. primary completion date | October 2014 |
| 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 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 include: - 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. Other protocol specific inclusion/exclusion criteria may apply. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Czech Republic | Investigational Site | Brno | |
| Czech Republic | Investigational Site | Hradec Kralove | |
| Czech Republic | Investigational Site | Most | |
| Czech Republic | Investigational Site | Olomouc | |
| Czech Republic | Investigational Site | Praha 10 | |
| Czech Republic | Investigational Site | Praha 4 - Krc | |
| Czech Republic | Investigational Site | Praha 6 | |
| Czech Republic | Investigational Site | Rychnov nad Kneznou | |
| Czech Republic | Investigational Site | Sternberk | |
| Czech Republic | Investigational Site | Vysoke Myto | |
| Czech Republic | Investigational Site | Zlin | |
| Czech Republic | Investigational Site | Znojmo | |
| Italy | Investigational Site | Catania | |
| Poland | Investigational Site | Bielsko-Biala | |
| Poland | Investigational Site | Bydgoszcz | |
| Poland | Investigational Site | Bydgoszcz | |
| Poland | Investigational Site | Gdansk | |
| Poland | Investigational Site | Gdansk | |
| Poland | Investigational Site | Gdynia | |
| Poland | Investigational Site | Katowice | |
| Poland | Investigational Site | Katowice | |
| Poland | Investigational Site | Lublin | |
| Poland | Investigational Site | Lublin | |
| Poland | Investigational Site | Torun | |
| United States | Investigational Site | Alabaster | Alabama |
| United States | Investigational Site | Albuquerque | New Mexico |
| United States | Investigational Site | Altoona | Pennsylvania |
| United States | Investigational Site | Anaheim | California |
| United States | Investigational Site | Anaheim | California |
| United States | Investigational Site | Anaheim | California |
| United States | Investigational Site | Arlington | Texas |
| United States | Investigational Site | Athens | Texas |
| United States | Investigational Site | Austell | Georgia |
| United States | Investigational Site | Austin | Texas |
| United States | Investigational Site | Aventura | Florida |
| United States | Investigational Site | Baton Rouge | Louisiana |
| United States | Investigational Site | Bay City | Michigan |
| United States | Investigational Site | Beavercreek | Ohio |
| United States | Investigational Site | Birmingham | Alabama |
| United States | Investigational Site | Bloomington | Illinois |
| United States | Investigational Site | Blue Ridge | Georgia |
| United States | Investigational Site | Boise | Idaho |
| United States | Investigational Site | Boynton Beach | Florida |
| United States | Investigational Site | Bradenton | Florida |
| United States | Investigational Site | Canton | Georgia |
| United States | Investigational Site | Cedarhurst | New York |
| United States | Investigational Site | Chicago | Illinois |
| United States | Investigational Site | Chino | California |
| United States | Investigational Site | Cincinnati | Ohio |
| United States | Investigational Site | Clearwater | Florida |
| United States | Investigational Site | Clermont | Florida |
| United States | Investigational Site | Cleveland | Ohio |
| United States | Investigational Site | Clinton | Utah |
| United States | Investigational Site | Columbus | Ohio |
| United States | Investigational Site | Columbus | Ohio |
| United States | Investigational Site | Columbus | Georgia |
| United States | Investigational Site | Coral Gables | Florida |
| United States | Investigational Site | Covington | Louisiana |
| United States | Investigational Site | Dallas | Texas |
| United States | Investigational Site | Dallas | Texas |
| United States | Investigational Site | Daytona Beach | Florida |
| United States | Investigational Site | Elkin | North Carolina |
| United States | Investigational Site | Evansville | Indiana |
| United States | Investigational Site | Fall River | Massachusetts |
| United States | Investigational Site | Franklin | Ohio |
| United States | Investigational Site | Franklin | Tennessee |
| United States | Investigational Site | Fresno | California |
| United States | Investigational Site | Fresno | California |
| United States | Investigational Site | Ft. Lauderdale | Florida |
| United States | Investigational Site | Glendale | California |
| United States | Investigational Site | Golden | Colorado |
| United States | Investigational Site | Goodyear | Arizona |
| United States | Investigational Site | Goodyear | Arizona |
| United States | Investigational Site | Great Neck | New York |
| United States | Investigational Site | Groveport | Ohio |
| United States | Investigational Site | Gulf Shores | Alabama |
| United States | Investigational Site | Hazelwood | Missouri |
| United States | Investigational Site | Hialeah | Florida |
| United States | Investigational Site | Hialeah | Florida |
| United States | Investigational Site | Hollywood | Maryland |
| United States | Investigational Site | Homewood | Alabama |
| United States | Investigational Site | Hot Springs | Arkansas |
| United States | Investigational Site | Houston | Texas |
| United States | Investigational Site | Houston | Texas |
| United States | Investigational Site | Houston | Texas |
| United States | Investigational Site | Houston | Texas |
| United States | Investigational Site | Houston | Texas |
| United States | Investigational Site | Houston | Texas |
| United States | Investigational Site | Houston | Texas |
| United States | Investigational Site | Houston | Texas |
| United States | Investigational Site | Humble | Texas |
| United States | Investigational Site | Huntsville | Alabama |
| United States | Investigational Site | Inverness | Florida |
| United States | Investigational Site | Jacksonville | Florida |
| United States | Investigational Site | Jacksonville | Florida |
| United States | Investigational Site | Jenkintown | Pennsylvania |
| United States | Investigational Site | Johns Creek | Georgia |
| United States | Investigational Site | Johnstown | Pennsylvania |
| United States | Investigational Site | Jupiter | Florida |
| United States | Investigational Site | Kansas City | Kansas |
| United States | Investigational Site | La Mesa | California |
| United States | Investigational Site | Laguna Hills | California |
| United States | Investigational Site | Las Vegas | Nevada |
| United States | Investigational Site | Lexington | Kentucky |
| United States | Investigational Site | Little Rock | Arkansas |
| United States | Investigational Site | Long Beach | California |
| United States | Investigational Site | Los Angeles | California |
| United States | Investigational Site | Los Angeles | California |
| United States | Investigational Site | Los Angeles | California |
| United States | Investigational Site | Los Gatos | California |
| United States | Investigational Site | Madisonville | Kentucky |
| United States | Investigational Site | Marietta | Georgia |
| United States | Investigational Site | Marrero | Louisiana |
| United States | Investigational Site | Meridian | Idaho |
| United States | Investigational Site | Metairie | Louisiana |
| United States | Investigational Site | Miami | Florida |
| United States | Investigational Site | Miami | Florida |
| United States | Investigational Site | Miami | Florida |
| United States | Investigational Site | Miami | Florida |
| United States | Investigational Site | Miami | Florida |
| United States | Investigational Site | Miami Lakes | Florida |
| United States | Investigational Site | Mobile | Alabama |
| United States | Investigational Site | Myrtle Beach | South Carolina |
| United States | Investigational Site | Naples | Florida |
| United States | Investigational Site | Naples | Florida |
| United States | Investigational Site | National City | California |
| United States | Investigational Site | New Haven | Connecticut |
| United States | Investigational Site | New Port Richey | Florida |
| United States | Investigational Site | New Tazewell | Tennessee |
| United States | Investigational Site | New Windsor | New York |
| United States | Investigational Site | New York | New York |
| United States | Investigational Site | North Attleboro | Massachusetts |
| United States | Investigational Site | North Hollywood | California |
| United States | Investigational Site | North Massapequa | New York |
| United States | Investigational Site | North Miami Beach | Florida |
| United States | Investigational Site | North Richland Hills | Texas |
| United States | Investigational Site | Oceanside | California |
| United States | Investigational Site | Oklahoma City | Oklahoma |
| United States | Investigational Site | Orlando | Florida |
| United States | Investigational Site | Oviedo | Florida |
| United States | Investigational Site | Paramount | California |
| United States | Investigational Site | Perry | Georgia |
| United States | Investigational Site | Philadelphia | Pennsylvania |
| United States | Investigational Site | Phoenix | Arizona |
| United States | Investigational Site | Phoenix | Arizona |
| United States | Investigational Site | Phoenixville | Pennsylvania |
| United States | Investigational Site | Pinconning | Michigan |
| United States | Investigational Site | Pinellas Park | Florida |
| United States | Investigational Site | Pinellas Park | Florida |
| United States | Investigational Site | Plano | Texas |
| United States | Investigational Site | Plantation | Florida |
| United States | Investigational Site | Port Orange | Florida |
| United States | Investigational Site | Richmond | California |
| United States | Investigational Site | Richmond | Virginia |
| United States | Investigational Site | Richmond | Virginia |
| United States | Investigational Site | Rochester | Michigan |
| United States | Investigational Site | Roseville | California |
| United States | Investigational Site | Sacramento | California |
| United States | Investigational Site | Sacramento | California |
| United States | Investigational Site | Salt Lake City | Utah |
| United States | Investigational Site | Salt Lake City | Utah |
| United States | Investigational Site | San Antonio | Texas |
| United States | Investigational Site | San Antonio | Texas |
| United States | Investigational Site | San Diego | California |
| United States | Investigational Site | Sanford | Florida |
| United States | Investigational Site | Santa Ana | California |
| United States | Investigational Site | Santa Clarita | California |
| United States | Investigational Site | Savannah | Georgia |
| United States | Investigational Site | South Miami | Florida |
| United States | Investigational Site | Spartanburg | South Carolina |
| United States | Investigational Site | St. Louis | Missouri |
| United States | Investigational Site | St. Louis | Missouri |
| United States | Investigational Site | Stratford | New Jersey |
| United States | Investigational Site | Sugar Land | Texas |
| United States | Investigational Site | Tamarac | Florida |
| United States | Investigational Site | Tampa | Florida |
| United States | Investigational Site | Tampa | Florida |
| United States | Investigational Site | Tempe | Arizona |
| United States | Investigational Site | Tipton | Pennsylvania |
| United States | Investigational Site | Toledo | Ohio |
| United States | Investigational Site | Tomball | Texas |
| United States | Investigational Site | Toms River | New Jersey |
| United States | Investigational Site | Troy | Michigan |
| United States | Investigational Site | Tucson | Arizona |
| United States | Investigational Site | Valley Village | California |
| United States | Investigational Site | Virginia Beach | Virginia |
| United States | Investigational Site | Voorhees | New Jersey |
| United States | Investigational Site | Warwick | Rhode Island |
| United States | Investigational Site | Waterbury | Connecticut |
| United States | Investigational Site | Wellington | Florida |
| United States | Investigational Site | West Jordan | Utah |
| United States | Investigational Site | Wichita | Kansas |
| United States | Investigational Site | Williamsville | New York |
| United States | Investigational Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Purdue Pharma LP |
United States, Czech Republic, Italy, Poland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | CSBM Responder at least 50% of the weeks in the double-blind period | Weeks 1 through 12 | No | |
| Secondary | Laxative-free Responder at least 50% of the weeks in the double-blind period | Weeks 1 through 12 | No |
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