The purpose of this study is to evaluate the effectiveness of GW406381 (a COX-2 inhibitor) in treating the signs and symptoms of osteoarthritis of the knee.

Condition	Intervention	Phase
Osteoarthritis	Drug: GW406381 oral capsules  Drug: celecoxib oral capsules	Phase III

Further Study Details: 

Primary Outcomes: Change in OA symptoms at week 12 as measured by scores on subject-completed questionnaires on pain, daily activities and global assessment.
Secondary Outcomes: Change in OA symptoms.; Percentage of responders.; Subjects discontinuing due to lack of efficacy.; Use of rescue medication.; Health-related quality of life.
Expected Total Enrollment:  1113

Ages Eligible for Study:  40 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion criteria:

• Subjects have a primary diagnosis of osteoarthritis of the knee with symptom duration of at least 3 months.
• Use pain medication, such as a COX-2 inhibitor or NSAID (non-steroidal anti-inflammatory drug) at least 5 days per week.

Exclusion criteria:

• History of hypersensitivity or intolerance to pain medications.
• History of gastroduodenal perforations and/or obstructions.
• History of upper GI (gastrointestinal) ulceration within the previous 6 months.
• History of upper or lower GI bleeding within the previous year.
• History of inflammatory bowel disease.
• Currently take sucralfate or misoprostol.
• Currently taking aspirin daily for the heart.
• Other restrictions around the use medications apply and would need to be discussed.
• History of coronary artery disease, (angina, MI) or surgery.
• History of congestive heart failure or renal artery stenosis.
• History of stroke or transient ischemic attack.
• History of uncontrolled hypertension.

Please refer to this study by ClinicalTrials.gov identifier  NCT00120900

Alabama
      Scott Touger, Birmingham,  Alabama,  35205,  United States; Recruiting
      Gordon Connor, Birmingham,  Alabama,  35209,  United States; Recruiting
      Anthony Turkiewicz, Birmingham,  Alabama,  35294,  United States; Recruiting
      William Shergy, Huntsville,  Alabama,  35801,  United States; Recruiting
      Donna Paul, Montgomery,  Alabama,  36106,  United States; Recruiting
Arkansas
      William Scott Bowen, Little Rock,  Arkansas,  72205,  United States; Recruiting
      Beata Filip-Majewski, Jonesboro,  Arkansas,  72401,  United States; Recruiting
Connecticut
      Selwyn Cohen, Stratford,  Connecticut,  06615,  United States; Recruiting
District of Columbia
      David Borenstein, Washington,  District of Columbia,  20006,  United States; Recruiting
Florida
      Bruce Rankin, Deland,  Florida,  32720,  United States; Recruiting
      Timothy Truitt, Melbourne,  Florida,  32901,  United States; Recruiting
      Larry Gilderman, Pembroke Pines,  Florida,  33024,  United States; Recruiting
      Jeffrey Rosen, Coral Gables,  Florida,  33134,  United States; Recruiting
      Eric Sheldon, Miami,  Florida,  33173,  United States; Recruiting
      David Shepard, Tampa,  Florida,  33614,  United States; Recruiting
      Joel Silverfield, Tampa,  Florida,  33614,  United States; Recruiting
      Margarita Nunez, St. Petersburg,  Florida,  33702,  United States; Recruiting
      Steven Bowman, Clearwater,  Florida,  33761,  United States; Recruiting
      Robert DiGiovanni, Largo,  Florida,  33774,  United States; Recruiting
      Robert Schulman, Sarasota,  Florida,  34233,  United States; Recruiting
      Stephen Bookbinder, Ocala,  Florida,  34474,  United States; Recruiting
      Anthony Sebba, Palm Harbor,  Florida,  34684,  United States; Recruiting
      Darrell Fiske, Stuart,  Florida,  34996,  United States; Recruiting
Georgia
      Grattan Woodson, Decatur,  Georgia,  30033,  United States; Recruiting
      John Goldman, Roswell,  Georgia,  30075,  United States; Recruiting
Illinois
      Steven Portes, Libertyville,  Illinois,  60048,  United States; Recruiting
      Thomas Schnitzer, Chicago,  Illinois,  60611,  United States; Recruiting
      Robert Trapp, Springfield,  Illinois,  62704,  United States; Recruiting
Indiana
      Rose Fife, Indianapolis,  Indiana,  46202,  United States; Recruiting
      Steven Elliot, Evansville,  Indiana,  47714,  United States; Recruiting
      Moges Sisay, Evansville,  Indiana,  47714,  United States; Recruiting
Kansas
      Elizabeth Gallup, Mission,  Kansas,  66202,  United States; Recruiting
Kentucky
      Daksha Mehta, Elizabethtown,  Kentucky,  42701,  United States; Recruiting
      Jessica Robbins, Munfordville,  Kentucky,  42765,  United States; Recruiting
Louisiana
      Parimal Parikh, New Orleans,  Louisiana,  70115,  United States; Recruiting
      Marielisa Sedrish, Slidell,  Louisiana,  70458,  United States; Recruiting
      Floyd Jones, West Monroe,  Louisiana,  71291,  United States; Recruiting
Maryland
      Evan Siegel, Rockville,  Maryland,  20850,  United States; Recruiting
      Herbert Baraf, Wheaton,  Maryland,  20902,  United States; Recruiting
      Boris Kerzner, Baltimore,  Maryland,  21208,  United States; Recruiting
      Walter Koppel, Towson,  Maryland,  21286,  United States; Recruiting
Massachusetts
      Phyllis Troia, West Yarmouth,  Massachusetts,  02673,  United States; Recruiting
Michigan
      Richard Sharon, Royal Oak,  Michigan,  48073,  United States; Recruiting
      Justus Fiechtner, Lansing,  Michigan,  48910,  United States; Recruiting
Missouri
      Edward Kunst, Manchester,  Missouri,  63021,  United States; Recruiting
      James Greenwald, St. Louis,  Missouri,  63108,  United States; Recruiting
      Irl Don, St. Louis,  Missouri,  63117,  United States; Recruiting
      Anthony Margherita, St. Louis,  Missouri,  63141,  United States; Recruiting
      John Dexter, Springfield,  Missouri,  65804,  United States; Recruiting
Montana
      Howard Knapp, Billings,  Montana,  59101,  United States; Recruiting
New Hampshire
      Anthony Turkiewicz, Dover,  New Hampshire,  03820,  United States; Recruiting
New Jersey
      David Hodges, Englewood,  New Jersey,  07631,  United States; Recruiting
      David Hassman, Berlin,  New Jersey,  08009,  United States; Recruiting
New York
      Michael Katz, New York,  New York,  10003,  United States; Recruiting
      Douglas Zmolek, Manlius,  New York,  13104,  United States; Recruiting
      Bruce Bowling, Endwell,  New York,  13760,  United States; Recruiting
      Tammi Shlotzhauer, Rochester,  New York,  14609,  United States; Recruiting
      John Condemi, Rochester,  New York,  14618,  United States; Recruiting
North Carolina
      Mark Perini, Greensboro,  North Carolina,  27401,  United States; Recruiting
      Wayne Harper, Raleigh,  North Carolina,  27612,  United States; Recruiting
      Anthony Wheeler, Charlotte,  North Carolina,  28207,  United States; Recruiting
      Dennis Payne, Hickory,  North Carolina,  28601,  United States; Recruiting
Ohio
      Kevin Hackshaw, Columbus,  Ohio,  43210,  United States; Recruiting
      Michele Hooper, Beachwood,  Ohio,  44122,  United States; Recruiting
      David Mandel, Mayfield Village,  Ohio,  44143,  United States; Recruiting
      Bruce Corser, Cincinnati,  Ohio,  45219,  United States; Recruiting
      Mehmoodur Rasheed, Gallipolis,  Ohio,  45631,  United States; Recruiting
Oklahoma
      Angelique Barreto, Oklahoma City,  Oklahoma,  73112,  United States; Recruiting
      Larry Willis, Oklahoma City,  Oklahoma,  73112,  United States; Recruiting
      David Browning, Tulsa,  Oklahoma,  74104,  United States; Recruiting
Pennsylvania
      Paul Killian, Monroeville,  Pennsylvania,  15146,  United States; Recruiting
      Shelly Kafka, Duncansville,  Pennsylvania,  16635,  United States; Recruiting
      James McMillen, Mechanicsburg,  Pennsylvania,  17055,  United States; Recruiting
      Gary Gordon, Wynnewood,  Pennsylvania,  19096,  United States; Recruiting
      Barry Packman, Philadelphia,  Pennsylvania,  19115,  United States; Recruiting
      Robert Griffin, West Reading,  Pennsylvania,  19611,  United States; Recruiting
South Carolina
      Charles Fogarty, Spartanburg,  South Carolina,  29303,  United States; Recruiting
      William Edwards, Charleston,  South Carolina,  29406,  United States; Recruiting
      Richard Mills, Mt. Pleasant,  South Carolina,  29464,  United States; Recruiting
      Cynthia Strout, Mt. Pleasant,  South Carolina,  29464,  United States; Recruiting
      Jason Rosenberg, Murrells Inlet,  South Carolina,  29576,  United States; Recruiting
      William Ellison, Greer,  South Carolina,  29651,  United States; Recruiting
Tennessee
      Morin David, Bristol,  Tennessee,  37620,  United States; Recruiting
      James Schrenker, Bristol,  Tennessee,  37620,  United States; Recruiting
      Charles Debusk, New Tazewell,  Tennessee,  37825,  United States; Recruiting
      Howard Marker, Memphis,  Tennessee,  38119,  United States; Recruiting
      James Diffee, Jackson,  Tennessee,  38301,  United States; Recruiting
Virginia
      James Clark, Charlottesville,  Virginia,  22911,  United States; Recruiting
      Chester Fisher, Newport News,  Virginia,  23606,  United States; Recruiting
Wisconsin
      Dana Trotter, Racine,  Wisconsin,  53406,  United States; Recruiting
      Zorba Paster, Oregon,  Wisconsin,  53575,  United States; Recruiting

Study chairs or principal investigators

GSK Clinical Trial,  Study Director,  GlaxoSmithKline   

Study ID Numbers:  CXA30007
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 18, 2005
ClinicalTrials.gov Identifier:  NCT00120900
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-26