Clinical Trial: Osteoarthritis of the Knee

This study is currently recruiting patients.

Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline

Purpose

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

MedlinePlus related topics:  Osteoarthritis

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: A Phase III, 12-Week, Multicentre, Double-Blind, Double-Dummy, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381 1mg, 5mg, 10mg, 25mg and 50mg Administered Orally Once Daily, in Adults with Osteoarthritis of the Knee (CXA30007).

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

Study start: May 2005

Eligibility

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

Inclusion criteria:

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.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00120900


Alabama
      Scott Touger, Birmingham,  Alabama,  35205,  United States; Recruiting
Scott Touger  205-397-1280 

      Gordon Connor, Birmingham,  Alabama,  35209,  United States; Recruiting
Gordon Connor  205-870-8803 

      Anthony Turkiewicz, Birmingham,  Alabama,  35294,  United States; Recruiting
Anthony Turkiewicz  205-934-7727 

      William Shergy, Huntsville,  Alabama,  35801,  United States; Recruiting
William Shergy  256-265-6778 

      Donna Paul, Montgomery,  Alabama,  36106,  United States; Recruiting
Donna Paul  334-265-2700 

Arkansas
      William Scott Bowen, Little Rock,  Arkansas,  72205,  United States; Recruiting
William Scott Bowen  501-663-6455  Ext. 240 

      Beata Filip-Majewski, Jonesboro,  Arkansas,  72401,  United States; Recruiting
Beata Filip-Majewski  870-934-9933 

Connecticut
      Selwyn Cohen, Stratford,  Connecticut,  06615,  United States; Recruiting
Selwyn Cohen  203-386-3115 

District of Columbia
      David Borenstein, Washington,  District of Columbia,  20006,  United States; Recruiting
David Borenstein  202-293-1470 

Florida
      Bruce Rankin, Deland,  Florida,  32720,  United States; Recruiting
Bruce Rankin  386-740-0770 

      Timothy Truitt, Melbourne,  Florida,  32901,  United States; Recruiting
Timothy Truitt  321-723-1203 

      Larry Gilderman, Pembroke Pines,  Florida,  33024,  United States; Recruiting
Larry Gilderman  954-437-2024  Ext. 212 

      Jeffrey Rosen, Coral Gables,  Florida,  33134,  United States; Recruiting
Jeffrey Rosen  305-445-5637 

      Eric Sheldon, Miami,  Florida,  33173,  United States; Recruiting
Eric Sheldon  305-279-0015  Ext. 4231 

      David Shepard, Tampa,  Florida,  33614,  United States; Recruiting
David Shepard  813-618-0015 

      Joel Silverfield, Tampa,  Florida,  33614,  United States; Recruiting
Joel Silverfield  813-875-9742 

      Margarita Nunez, St. Petersburg,  Florida,  33702,  United States; Recruiting
Margarita Nunez  727-576-8474 

      Steven Bowman, Clearwater,  Florida,  33761,  United States; Recruiting
Steven Bowman  727-724-3316 

      Robert DiGiovanni, Largo,  Florida,  33774,  United States; Recruiting
Robert DiGiovanni  727-531-2848 

      Robert Schulman, Sarasota,  Florida,  34233,  United States; Recruiting
Robert Schulman  941-379-8810 

      Stephen Bookbinder, Ocala,  Florida,  34474,  United States; Recruiting
Stephen Bookbinder  352-861-6931 

      Anthony Sebba, Palm Harbor,  Florida,  34684,  United States; Recruiting
Anthony Sebba  727-210-2555 

      Darrell Fiske, Stuart,  Florida,  34996,  United States; Recruiting
Darrell Fiske  772-781-3000 

Georgia
      Grattan Woodson, Decatur,  Georgia,  30033,  United States; Recruiting
Grattan Woodson  404-298-9951 

      John Goldman, Roswell,  Georgia,  30075,  United States; Recruiting
John Goldman  770-226-8819 

Illinois
      Steven Portes, Libertyville,  Illinois,  60048,  United States; Recruiting
Steven Portes  847-362-9050  Ext. 135 

      Thomas Schnitzer, Chicago,  Illinois,  60611,  United States; Recruiting
Thomas Schnitzer  312-503-2312 

      Robert Trapp, Springfield,  Illinois,  62704,  United States; Recruiting
Robert Trapp  217-546-6888 

Indiana
      Rose Fife, Indianapolis,  Indiana,  46202,  United States; Recruiting
Rose Fife  371-278-3166 

      Steven Elliot, Evansville,  Indiana,  47714,  United States; Recruiting
Steven Elliot  812-471-4110 

      Moges Sisay, Evansville,  Indiana,  47714,  United States; Recruiting
Moges Sisay  501-221-5000 

Kansas
      Elizabeth Gallup, Mission,  Kansas,  66202,  United States; Recruiting
Elizabeth Gallup  913-236-7333 

Kentucky
      Daksha Mehta, Elizabethtown,  Kentucky,  42701,  United States; Recruiting
Daksha Mehta  270-769-2535 

      Jessica Robbins, Munfordville,  Kentucky,  42765,  United States; Recruiting
Jessica Robbins  270-524-1069 

Louisiana
      Parimal Parikh, New Orleans,  Louisiana,  70115,  United States; Recruiting
Parimal Parikh  504-897-5211 

      Marielisa Sedrish, Slidell,  Louisiana,  70458,  United States; Recruiting
Marielisa Sedrish  985-607-0050 

      Floyd Jones, West Monroe,  Louisiana,  71291,  United States; Recruiting
Floyd Jones  501-221-5000 

Maryland
      Evan Siegel, Rockville,  Maryland,  20850,  United States; Recruiting
Evan Siegel  301-942-6610 

      Herbert Baraf, Wheaton,  Maryland,  20902,  United States; Recruiting
Herbert Baraf  301-942-6610 

      Boris Kerzner, Baltimore,  Maryland,  21208,  United States; Recruiting
Boris Kerzner  410-484-9400 

      Walter Koppel, Towson,  Maryland,  21286,  United States; Recruiting
Walter Koppel  443-279-0330 

Massachusetts
      Phyllis Troia, West Yarmouth,  Massachusetts,  02673,  United States; Recruiting
Phyllis Troia  508-778-1339 

Michigan
      Richard Sharon, Royal Oak,  Michigan,  48073,  United States; Recruiting
Richard Sharon  248-435-6069 

      Justus Fiechtner, Lansing,  Michigan,  48910,  United States; Recruiting
Justus Fiechtner  517-272-9737 

Missouri
      Edward Kunst, Manchester,  Missouri,  63021,  United States; Recruiting
Edward Kunst  314-920-9182 

      James Greenwald, St. Louis,  Missouri,  63108,  United States; Recruiting
James Greenwald  314-367-0777 

      Irl Don, St. Louis,  Missouri,  63117,  United States; Recruiting
Irl Don  314-646-0688 

      Anthony Margherita, St. Louis,  Missouri,  63141,  United States; Recruiting
Anthony Margherita  314-692-2100 

      John Dexter, Springfield,  Missouri,  65804,  United States; Recruiting
John Dexter  417-841-3625 

Montana
      Howard Knapp, Billings,  Montana,  59101,  United States; Recruiting
Howard Knapp  406-255-8472 

New Hampshire
      Anthony Turkiewicz, Dover,  New Hampshire,  03820,  United States; Recruiting
Anthony Turkiewicz  603-742-3664  Ext. 17 

New Jersey
      David Hodges, Englewood,  New Jersey,  07631,  United States; Recruiting
David Hodges  201-816-0464 

      David Hassman, Berlin,  New Jersey,  08009,  United States; Recruiting
David Hassman  865-753-7335  Ext. 23 

New York
      Michael Katz, New York,  New York,  10003,  United States; Recruiting
Michael Katz  212-595-5012 

      Douglas Zmolek, Manlius,  New York,  13104,  United States; Recruiting
Douglas Zmolek  315-682-3263 

      Bruce Bowling, Endwell,  New York,  13760,  United States; Recruiting
Bruce Bowling  607-748-4081 

      Tammi Shlotzhauer, Rochester,  New York,  14609,  United States; Recruiting
Tammi Shlotzhauer  585-288-0890 

      John Condemi, Rochester,  New York,  14618,  United States; Recruiting
John Condemi  585-442-1980 

North Carolina
      Mark Perini, Greensboro,  North Carolina,  27401,  United States; Recruiting
Mark Perini  336-574-8020 

      Wayne Harper, Raleigh,  North Carolina,  27612,  United States; Recruiting
Wayne Harper  919-781-2514 

      Anthony Wheeler, Charlotte,  North Carolina,  28207,  United States; Recruiting
Anthony Wheeler  704-333-8410 

      Dennis Payne, Hickory,  North Carolina,  28601,  United States; Recruiting
Dennis Payne  828-345-5060 

Ohio
      Kevin Hackshaw, Columbus,  Ohio,  43210,  United States; Recruiting
Kevin Hackshaw  614-293-8093 

      Michele Hooper, Beachwood,  Ohio,  44122,  United States; Recruiting
Michele Hooper  216-591-1443  Ext. 15 

      David Mandel, Mayfield Village,  Ohio,  44143,  United States; Recruiting
David Mandel  440-449-8277 

      Bruce Corser, Cincinnati,  Ohio,  45219,  United States; Recruiting
Bruce Corser  513-721-3868 

      Mehmoodur Rasheed, Gallipolis,  Ohio,  45631,  United States; Recruiting
Mehmoodur Rasheed  513-961-2333 

Oklahoma
      Angelique Barreto, Oklahoma City,  Oklahoma,  73112,  United States; Recruiting
Angelique Barreto  405-843-0374 

      Larry Willis, Oklahoma City,  Oklahoma,  73112,  United States; Recruiting
Larry Willis  405-602-3939 

      David Browning, Tulsa,  Oklahoma,  74104,  United States; Recruiting
David Browning  981-749-1002 

Pennsylvania
      Paul Killian, Monroeville,  Pennsylvania,  15146,  United States; Recruiting
Paul Killian  412-856-1811 

      Shelly Kafka, Duncansville,  Pennsylvania,  16635,  United States; Recruiting
Shelly Kafka  814-693-0300  Ext. 124 

      James McMillen, Mechanicsburg,  Pennsylvania,  17055,  United States; Recruiting
James McMillen  717-766-4866 

      Gary Gordon, Wynnewood,  Pennsylvania,  19096,  United States; Recruiting
Gary Gordon  610-896-8400 

      Barry Packman, Philadelphia,  Pennsylvania,  19115,  United States; Recruiting
Barry Packman  215-671-1717 

      Robert Griffin, West Reading,  Pennsylvania,  19611,  United States; Recruiting
Robert Griffin  610-375-2466  Ext. 145 

South Carolina
      Charles Fogarty, Spartanburg,  South Carolina,  29303,  United States; Recruiting
Charles Fogarty  864-583-1556 

      William Edwards, Charleston,  South Carolina,  29406,  United States; Recruiting
William Edwards  843-572-1818 

      Richard Mills, Mt. Pleasant,  South Carolina,  29464,  United States; Recruiting
Richard Mills  843-849-1880 

      Cynthia Strout, Mt. Pleasant,  South Carolina,  29464,  United States; Recruiting
Cynthia Strout  843-856-3784 

      Jason Rosenberg, Murrells Inlet,  South Carolina,  29576,  United States; Recruiting
Jason Rosenberg  843-344-2635 

      William Ellison, Greer,  South Carolina,  29651,  United States; Recruiting
William Ellison  864-877-9239  Ext. 230 

Tennessee
      Morin David, Bristol,  Tennessee,  37620,  United States; Recruiting
Morin David  423-989-3015 

      James Schrenker, Bristol,  Tennessee,  37620,  United States; Recruiting
James Schrenker  423-990-2497 

      Charles Debusk, New Tazewell,  Tennessee,  37825,  United States; Recruiting
Charles Debusk  423-626-7297  Ext. 40 

      Howard Marker, Memphis,  Tennessee,  38119,  United States; Recruiting
Howard Marker  901-761-5062 

      James Diffee, Jackson,  Tennessee,  38301,  United States; Recruiting
James Diffee  731-660-8320 

Virginia
      James Clark, Charlottesville,  Virginia,  22911,  United States; Recruiting
James Clark  434-817-2442 

      Chester Fisher, Newport News,  Virginia,  23606,  United States; Recruiting
Chester Fisher  757-591-8100 

Wisconsin
      Dana Trotter, Racine,  Wisconsin,  53406,  United States; Recruiting
Dana Trotter  262-637-1000 

      Zorba Paster, Oregon,  Wisconsin,  53575,  United States; Recruiting
Zorba Paster  608-835-1014 

Study chairs or principal investigators

GSK Clinical Trial,  Study Director,  GlaxoSmithKline   

More Information

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

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