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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

This study is currently Recruiting

November 2011 By Pfizer

First Recieved on November 29, 2007

Last Updated on November 7, 2011

Sponsor: Pfizer
Collaborators:
Information provided by: Pfizer
Identifier: NCT00565812

Purpose

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.

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:40 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

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

Investigators

  • Investigator: Pfizer CT.gov Call Center - Study Director - Pfizer

Locations

  • Pfizer Investigational Site

    Birmingham, Alabama 35242 United States

  • Pfizer Investigational Site

    Birmingham, Alabama 35209 United States

  • Pfizer Investigational Site

    Peoria, Arizona 85381 United States

  • Pfizer Investigational Site

    Peoria, Arizona 85381 United States

  • Pfizer Investigational Site

    Phoenix, Arizona 85027 United States

  • Pfizer Investigational Site

    Phoenix, Arizona 85023 United States

  • Pfizer Investigational Site

    Tucson, Arizona 85724 United States

  • Pfizer Investigational Site

    Little Rock, Arkansas 72205 United States

  • Pfizer Investigational Site

    Carmichael, California 95608 United States

  • Pfizer Investigational Site

    Costa Mesa, California 92627 United States

  • Pfizer Investigational Site

    Fair Oaks, California 95628 United States

  • Pfizer Investigational Site

    Roseville, California 95661 United States

  • Pfizer Investigational Site

    Sacramento, California 95817 United States

  • Pfizer Investigational Site

    San Diego, California 92128 United States

  • Pfizer Investigational Site

    Denver, Colorado 80209 United States

  • Pfizer Investigational Site

    Golden, Colorado 80401 United States

  • Pfizer Investigational Site

    Stamford, Connecticut 06905 United States

  • Pfizer Investigational Site

    Trumbull, Connecticut 06611 United States

  • Pfizer Investigational Site

    Gainesville, Florida 32607 United States

  • Pfizer Investigational Site

    Gainsville, Florida 32607 United States

  • Pfizer Investigational Site

    Jacksonville, Florida 32216 United States

  • Pfizer Investigational Site

    Plantation, Florida 33324 United States

  • Pfizer Investigational Site

    Plantation, Florida 33317 United States

  • Pfizer Investigational Site

    West Palm Beach, Florida 33407 United States

  • Pfizer Investigational Site

    Woodstock, Georgia 30189 United States

  • Pfizer Investigational Site

    Honolulu, Hawaii 96814 United States

  • Pfizer Investigational Site

    Chicago, Illinois 60611 United States

  • Pfizer Investigational Site

    Evanston, Illinois 60201 United States

  • Pfizer Investigational Site

    Glenview, Illinois 60025 United States

  • Pfizer Investigational Site

    Gurnee, Illinois 60031 United States

  • Pfizer Investigational Site

    Morton Grove, Illinois 60053 United States

  • Pfizer Investigational Site

    Springfield, Illinois 62704 United States

  • Pfizer Investigational Site

    Vernon Hills, Illinois 60061 United States

  • Pfizer Investigational Site

    Avon, Indiana 46123 United States

  • Pfizer Investigational Site

    New Albany, Indiana 47150 United States

  • Pfizer Investigational Site

    Wichita, Kansas 67205 United States

  • Pfizer Investigational Site

    Wichita, Kansas 67207 United States

  • Pfizer Investigational Site

    Lexington, Kentucky 40517 United States

  • Pfizer Investigational Site

    Louisville, Kentucky 40213 United States

  • Pfizer Investigational Site

    Madisonville, Kentucky 42431 United States

  • Pfizer Investigational Site

    Shreveport, Louisiana 71115 United States

  • Pfizer Investigational Site

    Portland, Maine 04102 United States

  • Pfizer Investigational Site

    Wheaton, Maryland 20902 United States

  • Pfizer Investigational Site

    Brockton, Massachusetts 02301 United States

  • Pfizer Investigational Site

    Fall River, Massachusetts 02720 United States

  • Pfizer Investigational Site

    Fall River, Massachusetts 02721 United States

  • Pfizer Investigational Site

    New Bedford, Massachusetts 02740 United States

  • Pfizer Investigational Site

    Wellesley Hills, Massachusetts 02481-2106 United States

  • Pfizer Investigational Site

    Worcester, Massachusetts 01605 United States

  • Pfizer Investigational Site

    Cadillac, Michigan 49601 United States

  • Pfizer Investigational Site

    Flowood, Mississippi 39232 United States

  • Pfizer Investigational Site

    Port Gibson, Mississippi 39150 United States

  • Pfizer Investigational Site

    Tupelo, Mississippi 38801 United States

  • Pfizer Investigational Site

    Chesterfield, Missouri 63017 United States

  • Pfizer Investigational Site

    Kansas City, Missouri 64114 United States

  • Pfizer Investigational Site

    Kansas City, Missouri 64114 United States

  • Pfizer Investigational Site

    Las Vegas, Nevada 89128 United States

  • Pfizer Investigational Site

    Las Vegas, Nevada 89118 United States

  • Pfizer Investigational Site

    Las Vegas, Nevada 89144 United States

  • Pfizer Investigational Site

    Las Vegas, Nevada 89109 United States

  • Pfizer Investigational Site

    Las Vegas, Nevada 89117 United States

  • Pfizer Investigational Site

    Endwell, New York 13760 United States

  • Pfizer Investigational Site

    New York, New York 10003 United States

  • Pfizer Investigational Site

    Rochester, New York 14625 United States

  • Pfizer Investigational Site

    Syracuse, New York 13210 United States

  • Pfizer Investigational Site

    Burlington, North Carolina 27215 United States

  • Pfizer Investigational Site

    Greensboro, North Carolina 27408 United States

  • Pfizer Investigational Site

    Greensboro, North Carolina 27407 United States

  • Pfizer Investigational Site

    Mooresville, North Carolina 28117 United States

  • Pfizer Investigational Site

    Salisbury, North Carolina 28144 United States

  • Pfizer Investigational Site

    Statesville, North Carolina 28625 United States

  • Pfizer Investigational Site

    Wilmington, North Carolina 28401 United States

  • Pfizer Investigational Site

    Fargo, North Dakota 58103 United States

  • Pfizer Investigational Site

    Beachwood, Ohio 44122 United States

  • Pfizer Investigational Site

    Columbus, Ohio 43213 United States

  • Pfizer Investigational Site

    Columbus, Ohio 43235 United States

  • Pfizer Investigational Site

    Bethlehem, Pennsylvania 18015 United States

  • Pfizer Investigational Site

    Duncansville, Pennsylvania 16635 United States

  • Pfizer Investigational Site

    Pawtucket, Rhode Island 02860 United States

  • Pfizer Investigational Site

    Charleston, South Carolina 29407 United States

  • Pfizer Investigational Site

    Greer, South Carolina 29651 United States

  • Pfizer Investigational Site

    Fayetteville, Tennessee 37334 United States

  • Pfizer Investigational Site

    Kingsport, Tennessee 37660 United States

  • Pfizer Investigational Site

    Knoxville, Tennessee 37920 United States

  • Pfizer Investigational Site

    Memphis, Tennessee 38125 United States

  • Pfizer Investigational Site

    Dallas, Texas 75231 United States

  • Pfizer Investigational Site

    San Antonio, Texas 78218 United States

  • Pfizer Investigational Site

    San Antonio, Texas 78217 United States

  • Pfizer Investigational Site

    Midvale, Utah 84047 United States

  • Pfizer Investigational Site

    Norfolk, Virginia 23502 United States

  • Pfizer Investigational Site

    Richmond, Virginia 23294 United States

  • Pfizer Investigational Site

    Virginia Beach, Virginia 23454 United States

  • Pfizer Investigational Site

    Tacoma, Washington 98405 United States

  • Pfizer Investigational Site

    Kenosha, Wisconsin 53142 United States

  • Pfizer Investigational Site

    Buenos Aires, C1114AAH Argentina

  • Pfizer Investigational Site

    Buenos Aires, C1034ACO Argentina

  • Pfizer Investigational Site

    Buenos Aires, C1405BCH Argentina

  • Pfizer Investigational Site

    Buenos Aires, C1013AAR Argentina

  • Pfizer Investigational Site

    Buenos Aires, C1425AWC Argentina

  • Pfizer Investigational Site

    Hobart, Tasmania 7000 Australia

  • Pfizer Investigational Site

    Bruxelles, 1200 Belgium

  • Pfizer Investigational Site

    Leuven, 3000 Belgium

  • Pfizer Investigational Site

    Edmonton, Alberta T5M 0H4 Canada

  • Pfizer Investigational Site

    St. John's, Newfoundland and Labrador A1A 5E8 Canada

  • Pfizer Investigational Site

    Newmarket, Ontario L3Y 3R7 Canada

  • Pfizer Investigational Site

    Sainte-Foy, Quebec G1W 4R4 Canada

  • Pfizer Investigational Site

    Brno, 656 91 Czech Republic

  • Pfizer Investigational Site

    Brno - Zidenice, 615 00 Czech Republic

  • Pfizer Investigational Site

    Ceske Budejovice, 370 01 Czech Republic

  • Pfizer Investigational Site

    Hostivice, 253 01 Czech Republic

  • Pfizer Investigational Site

    Praha 1, 11000 Czech Republic

  • Pfizer Investigational Site

    Praha 1, 11000 Czech Republic

  • Pfizer Investigational Site

    Praha 11 - Chodov, 148 00 Czech Republic

  • Pfizer Investigational Site

    Praha 11 - Chodov, 148 00 Czech Republic

  • Pfizer Investigational Site

    Praha 2, 128 50 Czech Republic

  • Pfizer Investigational Site

    Praha 6, 162 00 Czech Republic

  • Pfizer Investigational Site

    Praha 6, 169 00 Czech Republic

  • Pfizer Investigational Site

    Zlin, 760 01 Czech Republic

  • Pfizer Investigational Site

    Bad Hersfeld, 36251 Germany

  • Pfizer Investigational Site

    Berlin, 13125 Germany

  • Pfizer Investigational Site

    Berlin, 12247 Germany

  • Pfizer Investigational Site

    Deggingen, 73326 Germany

  • Pfizer Investigational Site

    Schwerin, 19055 Germany

  • Pfizer Investigational Site

    Budapest, 1126 Hungary

  • Pfizer Investigational Site

    Budapest, H-1036 Hungary

  • Pfizer Investigational Site

    Eger, 3300 Hungary

  • Pfizer Investigational Site

    Gyula, 5700 Hungary

  • Pfizer Investigational Site

    Komarom, 2900 Hungary

  • Pfizer Investigational Site

    Szolnok, H-5000 Hungary

  • Pfizer Investigational Site

    Veszprem, H-8200 Hungary

  • Pfizer Investigational Site

    Arenzano, 16011 Italy

  • Pfizer Investigational Site

    Jesi (Ancona), 60035 Italy

  • Pfizer Investigational Site

    Milano, 20157 Italy

  • Pfizer Investigational Site

    Surco, Lima Lima 33 Peru

  • Pfizer Investigational Site

    Callao, Callao-02 Peru

  • Pfizer Investigational Site

    Lima, Lima-27 Peru

  • Pfizer Investigational Site

    Lima, L-11 Peru

  • Pfizer Investigational Site

    Lima, L-27 Peru

  • Pfizer Investigational Site

    Lima, L-11 Peru

  • Pfizer Investigational Site

    Lima, L-29 Peru

  • Pfizer Investigational Site

    Cieszyn, 43-400 Poland

  • Pfizer Investigational Site

    Wroclaw, 50-556 Poland

  • Pfizer Investigational Site

    Wroclaw, 50-088 Poland

  • Pfizer Investigational Site

    Moscow, 115522 Russian Federation

  • Pfizer Investigational Site

    Moscow, 115093 Russian Federation

  • Pfizer Investigational Site

    St. Petersburg, 193312 Russian Federation

  • Pfizer Investigational Site

    St. Petersburg, 194291 Russian Federation

  • Pfizer Investigational Site

    St. Petersburg, 195427 Russian Federation

  • Pfizer Investigational Site

    Bratislava, 826 06 Slovakia

  • Pfizer Investigational Site

    Bratislava, Slovakia

  • Pfizer Investigational Site

    Piestany, 921 12 Slovakia

  • Pfizer Investigational Site

    Santiago de Compostela, A Coru?a 15705 Spain

  • Pfizer Investigational Site

    Guadalajara, 19002 Spain

  • Pfizer Investigational Site

    Sevilla, 41014 Spain

Conditions related to this trial:

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