Osteoarthritis Clinical Trial
— ITICOfficial title:
A Long-Term, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Radiographic Study to Investigate the Safety and Efficacy of Orally Administered SD-6010 in Subjects With Symptomatic Osteoarthritis of the Knee
| Verified date | February 2013 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The objective of this 2-year study is to evaluate the safety, tolerability and disease modifying efficacy of SD 6010, an inhibitor of inducible nitric oxide synthase (iNOS), in overweight and obese subjects with knee osteoarthritis. The efficacy of SD-6010 will be evaluated by radiography using joint space narrowing in the medial tibiofemoral compartment of the study knee as the primary endpoint.
| Status | Completed |
| Enrollment | 5077 |
| Est. completion date | November 2011 |
| Est. primary completion date | November 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years and older |
| Eligibility |
Inclusion Criteria: - Subjects aged >= 40 years with a BMI >= 25 and <= 40 kg/m2 - In the past, has been diagnosed with knee OA - Radiographic evidence of OA in the study knee Exclusion Criteria: - A diagnosis of any other rheumatic disease - Current conditions in the study knee that would confound efficacy - Selected, traditional clinical safety and laboratory parameters |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Pfizer Investigational Site | Buenos Aires | |
| Argentina | Pfizer Investigational Site | Buenos Aires | |
| Argentina | Pfizer Investigational Site | Buenos Aires | |
| Argentina | Pfizer Investigational Site | Buenos Aires | |
| Argentina | Pfizer Investigational Site | Buenos Aires | |
| Australia | Pfizer Investigational Site | Hobart | Tasmania |
| Belgium | Pfizer Investigational Site | Bruxelles | |
| Belgium | Pfizer Investigational Site | Leuven | |
| Canada | Pfizer Investigational Site | Edmonton | Alberta |
| Canada | Pfizer Investigational Site | Newmarket | Ontario |
| Canada | Pfizer Investigational Site | Sainte-Foy | Quebec |
| Canada | Pfizer Investigational Site | St. John's | Newfoundland and Labrador |
| Czech Republic | Pfizer Investigational Site | Brno | |
| Czech Republic | Pfizer Investigational Site | Brno - Zidenice | |
| Czech Republic | Pfizer Investigational Site | Ceske Budejovice | |
| Czech Republic | Pfizer Investigational Site | Hostivice | |
| Czech Republic | Pfizer Investigational Site | Praha 1 | |
| Czech Republic | Pfizer Investigational Site | Praha 11 - Chodov | |
| Czech Republic | Pfizer Investigational Site | Praha 2 | |
| Czech Republic | Pfizer Investigational Site | Praha 6 | |
| Czech Republic | Pfizer Investigational Site | Praha 6 | |
| Czech Republic | Pfizer Investigational Site | Zlin | |
| Germany | Pfizer Investigational Site | Bad Hersfeld | |
| Germany | Pfizer Investigational Site | Berlin | |
| Germany | Pfizer Investigational Site | Berlin | |
| Germany | Pfizer Investigational Site | Deggingen | |
| Germany | Pfizer Investigational Site | Schwerin | |
| Hungary | Pfizer Investigational Site | Budapest | |
| Hungary | Pfizer Investigational Site | Budapest | |
| Hungary | Pfizer Investigational Site | Eger | |
| Hungary | Pfizer Investigational Site | Gyula | |
| Hungary | Pfizer Investigational Site | Komarom | |
| Hungary | Pfizer Investigational Site | Szolnok | |
| Hungary | Pfizer Investigational Site | Veszprem | |
| Italy | Pfizer Investigational Site | Arenzano | |
| Italy | Pfizer Investigational Site | Jesi (Ancona) | |
| Italy | Pfizer Investigational Site | Milano | |
| Peru | Pfizer Investigational Site | Callao | |
| Peru | Pfizer Investigational Site | Lima | |
| Peru | Pfizer Investigational Site | Lima | |
| Peru | Pfizer Investigational Site | Lima | |
| Peru | Pfizer Investigational Site | Lima | |
| Peru | Pfizer Investigational Site | Santiago de Surco | Lima |
| Poland | Pfizer Investigational Site | Cieszyn | |
| Poland | Pfizer Investigational Site | Wroclaw | |
| Poland | Pfizer Investigational Site | Wroclaw | |
| Russian Federation | Pfizer Investigational Site | Moscow | |
| Russian Federation | Pfizer Investigational Site | Moscow | |
| Russian Federation | Pfizer Investigational Site | St. Petersburg | |
| Russian Federation | Pfizer Investigational Site | St. Petersburg | |
| Russian Federation | Pfizer Investigational Site | St. Petersburg | |
| Slovakia | Pfizer Investigational Site | Bratislava | |
| Slovakia | Pfizer Investigational Site | Bratislava | |
| Slovakia | Pfizer Investigational Site | Piestany | |
| Spain | Pfizer Investigational Site | Guadalajara | |
| Spain | Pfizer Investigational Site | Santiago de Compostela | A Coruña |
| Spain | Pfizer Investigational Site | Sevilla | |
| United States | Pfizer Investigational Site | Avon | Indiana |
| United States | Pfizer Investigational Site | Beachwood | Ohio |
| United States | Pfizer Investigational Site | Bethlehem | Pennsylvania |
| United States | Pfizer Investigational Site | Birmingham | Alabama |
| United States | Pfizer Investigational Site | Birmingham | Alabama |
| United States | Pfizer Investigational Site | Brockton | Massachusetts |
| United States | Pfizer Investigational Site | Burlington | North Carolina |
| United States | Pfizer Investigational Site | Cadillac | Michigan |
| United States | Pfizer Investigational Site | Carmichael | California |
| United States | Pfizer Investigational Site | Charleston | South Carolina |
| United States | Pfizer Investigational Site | Chesterfield | Missouri |
| United States | Pfizer Investigational Site | Chicago | Illinois |
| United States | Pfizer Investigational Site | Columbus | Ohio |
| United States | Pfizer Investigational Site | Columbus | Ohio |
| United States | Pfizer Investigational Site | Costa Mesa | California |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | Denver | Colorado |
| United States | Pfizer Investigational Site | Duncansville | Pennsylvania |
| United States | Pfizer Investigational Site | Endwell | New York |
| United States | Pfizer Investigational Site | Evanston | Illinois |
| United States | Pfizer Investigational Site | Fair Oaks | California |
| United States | Pfizer Investigational Site | Fall River | Massachusetts |
| United States | Pfizer Investigational Site | Fall River | Massachusetts |
| United States | Pfizer Investigational Site | Fargo | North Dakota |
| United States | Pfizer Investigational Site | Fayetteville | Tennessee |
| United States | Pfizer Investigational Site | Flowood | Mississippi |
| United States | Pfizer Investigational Site | Gainesville | Florida |
| United States | Pfizer Investigational Site | Gainsville | Florida |
| United States | Pfizer Investigational Site | Glenview | Illinois |
| United States | Pfizer Investigational Site | Golden | Colorado |
| United States | Pfizer Investigational Site | Greensboro | North Carolina |
| United States | Pfizer Investigational Site | Greensboro | North Carolina |
| United States | Pfizer Investigational Site | Greer | South Carolina |
| United States | Pfizer Investigational Site | Gurnee | Illinois |
| United States | Pfizer Investigational Site | Honolulu | Hawaii |
| United States | Pfizer Investigational Site | Jacksonville | Florida |
| United States | Pfizer Investigational Site | Kansas City | Missouri |
| United States | Pfizer Investigational Site | Kenosha | Wisconsin |
| United States | Pfizer Investigational Site | Kingsport | Tennessee |
| United States | Pfizer Investigational Site | Knoxville | Tennessee |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Las Vegas | Nevada |
| United States | Pfizer Investigational Site | Lexington | Kentucky |
| United States | Pfizer Investigational Site | Little Rock | Arkansas |
| United States | Pfizer Investigational Site | Louisville | Kentucky |
| United States | Pfizer Investigational Site | Madisonville | Kentucky |
| United States | Pfizer Investigational Site | Memphis | Tennessee |
| United States | Pfizer Investigational Site | Midvale | Utah |
| United States | Pfizer Investigational Site | Mooresville | North Carolina |
| United States | Pfizer Investigational Site | Morton Grove | Illinois |
| United States | Pfizer Investigational Site | New Albany | Indiana |
| United States | Pfizer Investigational Site | New Bedford | Massachusetts |
| United States | Pfizer Investigational Site | New York | New York |
| United States | Pfizer Investigational Site | Norfolk | Virginia |
| United States | Pfizer Investigational Site | Pawtucket | Rhode Island |
| United States | Pfizer Investigational Site | Peoria | Arizona |
| United States | Pfizer Investigational Site | Phoenix | Arizona |
| United States | Pfizer Investigational Site | Phoenix | Arizona |
| United States | Pfizer Investigational Site | Plantation | Florida |
| United States | Pfizer Investigational Site | Plantation | Florida |
| United States | Pfizer Investigational Site | Port Gibson | Mississippi |
| United States | Pfizer Investigational Site | Portland | Maine |
| United States | Pfizer Investigational Site | Richmond | Virginia |
| United States | Pfizer Investigational Site | Rochester | New York |
| United States | Pfizer Investigational Site | Rockville | Maryland |
| United States | Pfizer Investigational Site | Roseville | California |
| United States | Pfizer Investigational Site | Sacramento | California |
| United States | Pfizer Investigational Site | Salisbury | North Carolina |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | San Diego | California |
| United States | Pfizer Investigational Site | Shreveport | Louisiana |
| United States | Pfizer Investigational Site | Springfield | Illinois |
| United States | Pfizer Investigational Site | Stamford | Connecticut |
| United States | Pfizer Investigational Site | Statesville | North Carolina |
| United States | Pfizer Investigational Site | Syracuse | New York |
| United States | Pfizer Investigational Site | Tacoma | Washington |
| United States | Pfizer Investigational Site | Trumbull | Connecticut |
| United States | Pfizer Investigational Site | Tucson | Arizona |
| United States | Pfizer Investigational Site | Tupelo | Mississippi |
| United States | Pfizer Investigational Site | Vernon Hills | Illinois |
| United States | Pfizer Investigational Site | Virginia Beach | Virginia |
| United States | Pfizer Investigational Site | Wellesley Hills | Massachusetts |
| United States | Pfizer Investigational Site | West Palm Beach | Florida |
| United States | Pfizer Investigational Site | Wheaton | Maryland |
| United States | Pfizer Investigational Site | Wichita | Kansas |
| United States | Pfizer Investigational Site | Wichita | Kansas |
| United States | Pfizer Investigational Site | Wilmington | North Carolina |
| United States | Pfizer Investigational Site | Woodstock | Georgia |
| United States | Pfizer Investigational Site | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Argentina, Australia, Belgium, Canada, Czech Republic, Germany, Hungary, Italy, Peru, Poland, Russian Federation, Slovakia, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Assessing the progression rate of joint space narrowing in the study knee of subjects diagnosed with knee OA over a 24-month period. | 24 months | No | |
| Secondary | Assessing the safety and tolerability of multiple doses of SD-6010 administered long-term in subjects diagnosed with knee OA; | 24 months | No | |
| Secondary | Assessing the clinical benefit of multiple doses of SD-6010 in subjects diagnosed with knee OA | 24 months | No |
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