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COX-2 Inhibitor Study In Patients With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00113308
Recruitment Status : Completed
First Posted : June 8, 2005
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
This study is being conducted to find out if an investigational drug called GW406381 can help people with rheumatoid arthritis.

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Drug: GW406381 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2208 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg Administered Orally Once Daily, in Adults With Rheumatoid Arthritis
Study Start Date : June 2005
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Percentage of American College of Rheumatology (ACR)20 Responders at Week 12 [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Change from baseline to each scheduled visit in tender/painful joint count (68 joint panel) [ Time Frame: Baseline and Week 12 ]
  2. Change from baseline to each scheduled visit in swollen joint count (66 joint panel) [ Time Frame: Baseline and Week 12 ]
  3. Change from baseline to each scheduled visit in patient's pain assessment (VAS) [ Time Frame: Baseline and Week 12 ]
  4. Change from baseline to each scheduled visit in physician's global assessment of arthritis condition [ Time Frame: Baseline and Week 12 ]
  5. Change from baseline to each scheduled visit in patient's global assessment of arthritis condition [ Time Frame: Baseline and Week 12 ]
  6. Change from baseline to each scheduled visit in functional disability index (HAQ) [ Time Frame: Baseline and Week 12 ]
  7. Change between baseline and end of treatment (or early withdrawal) in the Short Form - McGill Pain Questionnaire (SF-MPQ) [ Time Frame: Baseline and Up to Week 12 ]
  8. Change from baseline to each scheduled visit in C-reactive protein (CRP) [ Time Frame: Baseline and up to Week 12 ]
  9. Number of participants withdrawing from the study due to lack of efficacy [ Time Frame: Week 12 ]
  10. Number of participants who received supplementary analgesic therapy [ Time Frame: Week 12 ]
  11. Changes from pretreatment to on treatment and post-treatment follow-up in vital signs- systolic blood pressure (SBP) and diastolic blood pressure (DBP) [ Time Frame: Baseline and up to Week 12 ]
  12. Changes from pretreatment to on treatment and post-treatment follow-up in vital signs- heart rate (HR) [ Time Frame: Baseline and up to Week 12 ]
  13. Changes from pretreatment to on treatment and post-treatment follow-up in weight [ Time Frame: Baseline and Week 12 ]
  14. Number of participants with change in BMI of potential clinical concern [ Time Frame: Week 4, 4, 8, 12 and foloow up ]
  15. Number of participants with change from baseline of pedal oedema (including diuretic use) [ Time Frame: Baseline and up to Week 12 ]
  16. Change from baseline in 12-lead electrocardiograms (ECGs) [ Time Frame: Baseline and up to Week 12 ]
  17. Change from baseline in clinical chemistry parameters: Albumin [ Time Frame: Baseline and up to Week 12 ]
  18. Change from baseline in clinical chemistry parameters: Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase [ Time Frame: Baseline and Up to Week 12 ]
  19. Change from baseline in clinical chemistry parameters: Total Bilirubin [ Time Frame: Baseline and up to Week 12 ]
  20. Change from baseline in clinical chemistry parameters: Carbon Dioxide content /Bicarbonate, Glucose, Potassium, Sodium [ Time Frame: Baseline and up to Week 12 ]
  21. Change from baseline in clinical chemistry parameters: Creatinine [ Time Frame: Baseline and up to Week 12 ]
  22. Change from baseline in haematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet count, White Blood Cell count [ Time Frame: Baseline and up to Week 12 ]
  23. Change from baseline in haematology parameters: Hemoglobin [ Time Frame: Baseline and up to Week 12 ]
  24. Change from baseline in haematology parameters: Mean Corpuscle volume [ Time Frame: Baseline and Up to Week 12 ]
  25. Change from baseline in haematology parameters: Red Blood Cell count [ Time Frame: Baseline and up to Week 12 ]
  26. Urinalysis assessment [ Time Frame: Up to Week 12 ]
  27. Number of participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Upto Week 12 ]
  28. Change in the Short Form-36 (SF-36v2) subscale scores between baseline and the end of treatment (or early withdrawal) [ Time Frame: Baseline and Week 12 ]
  29. Change in the Short Form-36 (SF-36v2) Physical component summary score and mental component summary score between baseline and the end of treatment (or early withdrawal) [ Time Frame: Baseline and Week 12 ]
  30. Psychometrically test and validate the amended Patient Satisfaction with Pain Medication questionnaire [ Time Frame: Week 12 ]
  31. Change between baseline and end of treatment (or early withdrawal) in the EuroQoL Questionnaire -5 Dimensions (EQ-5D) utility score, using European population utility tariff [ Time Frame: Baseline and Week 12 ]
  32. Change between baseline and end of treatment (or early withdrawal) in the fatigue/inertia factor of the Profile of Moods States Brief Form (POMS-B) [ Time Frame: Baseline and Week 12 ]


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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Rheumatoid arthritis (RA) for at least 12 months.
  • Required a non-steroidal anti-inflammatory drug (NSAID) or COX-2 inhibitor for RA for at least 5 out of 7 days of each week for the 4 weeks prior to screening.

Exclusion criteria:

  • Any history of cardiovascular disease (e.g., heart attack, stroke, congestive heart failure, uncontrolled high blood pressure), documented peripheral arterial insufficiency and symptomatic, clinically significant claudication, or who have a history of peripheral arterial embolism.
  • Have an active stomach ulcer or history of any stomach tear or bleeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00113308


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Locations
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United States, Alabama
GSK Investigational Site
Anniston, Alabama, United States, 36207
GSK Investigational Site
Birmingham, Alabama, United States, 35205
GSK Investigational Site
Birmingham, Alabama, United States, 35215
GSK Investigational Site
Huntsville, Alabama, United States, 35801
GSK Investigational Site
Montgomery, Alabama, United States, 36106
GSK Investigational Site
Montgomery, Alabama, United States, 36111
United States, Arizona
GSK Investigational Site
Glendale, Arizona, United States, 85308
GSK Investigational Site
Scottsdale, Arizona, United States, 85251
GSK Investigational Site
Tucson, Arizona, United States, 85704
GSK Investigational Site
Tucson, Arizona, United States, 85719
United States, California
GSK Investigational Site
Anaheim, California, United States, 92801
GSK Investigational Site
Palm Desert, California, United States, 92260
GSK Investigational Site
San Diego, California, United States, 92103-6204
GSK Investigational Site
San Diego, California, United States, 92108
GSK Investigational Site
San Diego, California, United States, 92128
GSK Investigational Site
Santa Monica, California, United States, 90048
GSK Investigational Site
Upland, California, United States, 91786
United States, Colorado
GSK Investigational Site
Colorado Springs, Colorado, United States, 80909
United States, Connecticut
GSK Investigational Site
Bridgeport, Connecticut, United States, 06606
GSK Investigational Site
Danbury, Connecticut, United States, 06810
GSK Investigational Site
Hamden, Connecticut, United States, 06518
GSK Investigational Site
Trumbull, Connecticut, United States, 06611
United States, Florida
GSK Investigational Site
Aventura, Florida, United States, 33180
GSK Investigational Site
Daytona Beach, Florida, United States, 32114
GSK Investigational Site
Deland, Florida, United States, 32720
GSK Investigational Site
Dunedin, Florida, United States, 34698
GSK Investigational Site
Largo, Florida, United States, 33773
GSK Investigational Site
Miami, Florida, United States, 33156
GSK Investigational Site
Miami, Florida, United States, 33173
GSK Investigational Site
Ocala, Florida, United States, 34474
GSK Investigational Site
Orlando, Florida, United States, 32804
GSK Investigational Site
Orlando, Florida, United States, 32806
GSK Investigational Site
Palm Harbor, Florida, United States, 34684
GSK Investigational Site
Port Orange, Florida, United States, 32127
GSK Investigational Site
Stuart, Florida, United States, 34996
GSK Investigational Site
Tampa, Florida, United States, 33614
GSK Investigational Site
Trinity, Florida, United States, 34655
GSK Investigational Site
West Palm Beach, Florida, United States, 33409
GSK Investigational Site
Zephyrhills, Florida, United States, 33540
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30342
GSK Investigational Site
Gainsville, Georgia, United States, 30501
GSK Investigational Site
Roswell, Georgia, United States, 30075
GSK Investigational Site
Woodstock, Georgia, United States, 30189
United States, Idaho
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Idaho Falls, Idaho, United States, 83401
United States, Illinois
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Evanston, Illinois, United States, 60201
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Morton Grove, Illinois, United States, 60053
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Springfield, Illinois, United States, 62704
United States, Indiana
GSK Investigational Site
Evansville, Indiana, United States, 47714
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
GSK Investigational Site
Indianapolis, Indiana, United States, 46227
United States, Kansas
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Prairie Village, Kansas, United States, 66206
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Wichita, Kansas, United States, 67207
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Louisville, Kentucky, United States, 40202
GSK Investigational Site
Louisville, Kentucky, United States, 40207
GSK Investigational Site
Louisville, Kentucky, United States, 40213
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New Orleans, Louisiana, United States, 70115
GSK Investigational Site
Slidell, Louisiana, United States, 70458
United States, Maryland
GSK Investigational Site
Wheaton, Maryland, United States, 20902
United States, Massachusetts
GSK Investigational Site
Fall River, Massachusetts, United States, 02720
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Springfield, Massachusetts, United States, 01107
United States, Michigan
GSK Investigational Site
Kalamazoo, Michigan, United States, 49048
GSK Investigational Site
Lansing, Michigan, United States, 48910
United States, Missouri
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St. Louis, Missouri, United States, 63117
GSK Investigational Site
St. Louis, Missouri, United States, 63141
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Las Vegas, Nevada, United States, 89103
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Las Vegas, Nevada, United States, 89106
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Las Vegas, Nevada, United States, 89128
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Reno, Nevada, United States, 89502
United States, New Hampshire
GSK Investigational Site
Dover, New Hampshire, United States, 03820
United States, New Jersey
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Berlin, New Jersey, United States, 08009
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Mercerville, New Jersey, United States, 08619
United States, New York
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Johnson City, New York, United States, 13790
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Kingston, New York, United States, 12401
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New York, New York, United States, 10024
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North Massapequa, New York, United States, 11758
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Rochester, New York, United States, 14618
United States, North Carolina
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Charlotte, North Carolina, United States, 28210
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Gastonia, North Carolina, United States, 28054
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Hickory, North Carolina, United States, 28601
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Statesville, North Carolina, United States, 28625
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44130
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Columbus, Ohio, United States, 43210
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Concinnati, Ohio, United States, 45219
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Mayfield Village, Ohio, United States, 44143
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73112
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Tulsa, Oklahoma, United States, 74104
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Tulsa, Oklahoma, United States, 74135
United States, Oregon
GSK Investigational Site
Medford, Oregon, United States, 97504
United States, Pennsylvania
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Duncansville, Pennsylvania, United States, 16635
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Philadelphia, Pennsylvania, United States, 19118
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Philadelphia, Pennsylvania, United States, 19140
GSK Investigational Site
West Reading, Pennsylvania, United States, 19611
United States, South Carolina
GSK Investigational Site
Charleston, South Carolina, United States, 29406
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Charleston, South Carolina, United States, 29407
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Greer, South Carolina, United States, 29651
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Hampton, South Carolina, United States, 29924
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Murrells Inlet, South Carolina, United States, 29576
United States, Tennessee
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Memphis, Tennessee, United States, 38119
United States, Texas
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Austin, Texas, United States, 78705
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Dallas, Texas, United States, 75231
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San Antonio, Texas, United States, 78229
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San Antonio, Texas, United States, 78232
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Everett, Washington, United States, 98201
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Vancouver, Washington, United States, 98664
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Racine, Wisconsin, United States, 53404
Argentina
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Cordoba, Córdova, Argentina
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Córdoba, Córdova, Argentina, 5000
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Rosario, Santa Fe, Argentina, 2000
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Ciudad Autónoma de Buenos Aires, Argentina, 1013
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Ciudad Autónoma de Buenos Aires, Argentina, 1427
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, C1121ABE
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Ciudad Autónoma de Buenos Aires, Argentina, C1128AAF
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Ciudad Autónoma de Buenos Aires, Argentina, C1426BOR
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Cordoba, Argentina, 5000
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Quilmes, Argentina, 1878
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San Juan, Argentina, 5400
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Tucuman, Argentina, 4000
Austria
GSK Investigational Site
Vienna, Austria, A-1021
GSK Investigational Site
Vienna, Austria, A-1060
GSK Investigational Site
Vienna, Austria, A-1090
GSK Investigational Site
Vienna, Austria, A-1100
Belgium
GSK Investigational Site
Antwerpen, Belgium, 2020
GSK Investigational Site
Diepenbeek, Belgium, 3590
GSK Investigational Site
Lommel, Belgium, 3920
GSK Investigational Site
Mons, Belgium, 7000
Bulgaria
GSK Investigational Site
Pleven, Bulgaria, 5800
GSK Investigational Site
Sofia, Bulgaria, 1233
GSK Investigational Site
Sofia, Bulgaria, 1431/1000
GSK Investigational Site
Sofia, Bulgaria, 1431
GSK Investigational Site
Varna, Bulgaria, 9010
Canada, Alberta
GSK Investigational Site
Edmonton, Alberta, Canada, T5K 2A2
Canada, British Columbia
GSK Investigational Site
Penticton, British Columbia, Canada, V2A 3G8
GSK Investigational Site
Victoria, British Columbia, Canada, V8P 5P6
Canada, Manitoba
GSK Investigational Site
Winnipeg, Manitoba, Canada, R3A 1M3
Canada, Newfoundland and Labrador
GSK Investigational Site
Saint John's, Newfoundland and Labrador, Canada, A1B 3E1
Canada, Ontario
GSK Investigational Site
Kitchener, Ontario, Canada, N2M 5N6
GSK Investigational Site
Mississauga, Ontario, Canada, L5M 2V8
GSK Investigational Site
Toronto, Ontario, Canada, M4N 3M5
GSK Investigational Site
Toronto, Ontario, Canada, M5T 2S8
GSK Investigational Site
Toronto, Ontario, Canada, M9W 4L6
GSK Investigational Site
Windsor, Ontario, Canada, N8X 5A6
Canada, Quebec
GSK Investigational Site
Montreal, Quebec, Canada, H3T 1E2
GSK Investigational Site
Montreal, Quebec, Canada, H3Z 2Z3
GSK Investigational Site
Sainte-Foy, Quebec, Canada, G1W 4R4
GSK Investigational Site
St-Jerome, Quebec, Canada, J7Z 5T3
GSK Investigational Site
Trois-Rivieres, Quebec, Canada, G8Z 1Y2
Canada, Saskatchewan
GSK Investigational Site
Saskatoon, Saskatchewan, Canada, S7N 0W8
Chile
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 8380456
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile
GSK Investigational Site
Viña del Mar, Valparaíso, Chile
Costa Rica
GSK Investigational Site
San Jose, Costa Rica
Denmark
GSK Investigational Site
Aalborg, Denmark, 9000
GSK Investigational Site
Ishoj, Denmark, 2635
GSK Investigational Site
Odense C, Denmark, 5000
GSK Investigational Site
Vejle, Denmark, 7100
Finland
GSK Investigational Site
Helsinki, Finland, 00100
GSK Investigational Site
Hyvinkaa, Finland, 05800
GSK Investigational Site
Kuopio, Finland, 70100
France
GSK Investigational Site
Angers, France, 49100
GSK Investigational Site
Cahors cedex 9, France, 46005
GSK Investigational Site
Chilly Mazarin, France, 91380
GSK Investigational Site
Corbeil Essonnes Cedex, France, 91106
GSK Investigational Site
Grenoble cedex 09, France, 38042
GSK Investigational Site
Lyon, France, 69002
GSK Investigational Site
Paris cedex 12, France, 75571
GSK Investigational Site
Toulouse, France, 31300
GSK Investigational Site
Tours, France, 37000
Germany
GSK Investigational Site
Baden-Baden, Baden-Wuerttemberg, Germany, 76530
GSK Investigational Site
Deggingen, Baden-Wuerttemberg, Germany, 73326
GSK Investigational Site
Freiburg, Baden-Wuerttemberg, Germany, 79098
GSK Investigational Site
Kippenheim, Baden-Wuerttemberg, Germany, 77971
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 66111
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70469
GSK Investigational Site
Weinheim, Baden-Wuerttemberg, Germany, 69469
GSK Investigational Site
Bayreuth, Bayern, Germany, 95445
GSK Investigational Site
Erlangen, Bayern, Germany, 91054
GSK Investigational Site
Muenchen, Bayern, Germany, 80333
GSK Investigational Site
Muenchen, Bayern, Germany, 80339
GSK Investigational Site
Nuernberg, Bayern, Germany, 90402
GSK Investigational Site
Passau, Bayern, Germany, 94032
GSK Investigational Site
Huettenberg, Hessen, Germany, 35625
GSK Investigational Site
Wiesbaden, Hessen, Germany, 65185
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany, 19055
GSK Investigational Site
Einbeck, Niedersachsen, Germany, 37574
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30519
GSK Investigational Site
Hildesheim, Niedersachsen, Germany, 31134
GSK Investigational Site
Aachen, Nordrhein-Westfalen, Germany, 52064
GSK Investigational Site
Beckum, Nordrhein-Westfalen, Germany, 59269
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44787
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45326
GSK Investigational Site
Goch, Nordrhein-Westfalen, Germany, 47574
GSK Investigational Site
Hattingen, Nordrhein-Westfalen, Germany, 45525
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51069
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48155
GSK Investigational Site
Witten, Nordrhein-Westfalen, Germany, 58455
GSK Investigational Site
Rhaunen, Rheinland-Pfalz, Germany, 55624
GSK Investigational Site
Saarbruecken, Saarland, Germany, 66111
GSK Investigational Site
Wolmirstedt, Sachsen-Anhalt, Germany, 39326
GSK Investigational Site
Chemnitz, Sachsen, Germany, 09111
GSK Investigational Site
Delitzsch, Sachsen, Germany, 04509
GSK Investigational Site
Dresden, Sachsen, Germany, 01067
GSK Investigational Site
Freital, Sachsen, Germany, 01705
GSK Investigational Site
Goerlitz, Sachsen, Germany, 02826
GSK Investigational Site
Leipzig, Sachsen, Germany, 04107
GSK Investigational Site
Leipzig, Sachsen, Germany, 04229
GSK Investigational Site
Schmiedeberg, Sachsen, Germany, 01762
GSK Investigational Site
Elmshorn, Schleswig-Holstein, Germany, 25335
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23538
GSK Investigational Site
Pinneberg, Schleswig-Holstein, Germany, 25421
GSK Investigational Site
Berlin, Germany, 10777
GSK Investigational Site
Berlin, Germany, 12247
GSK Investigational Site
Berlin, Germany, 13125
GSK Investigational Site
Berlin, Germany, 14057
GSK Investigational Site
Berlin, Germany, 14109
GSK Investigational Site
Hamburg, Germany, 20249
GSK Investigational Site
Hamburg, Germany, 22143
GSK Investigational Site
Hamburg, Germany, 22415
Greece
GSK Investigational Site
Kavala, Greece, 65403
GSK Investigational Site
Thessaloniki, Greece, 546 36
GSK Investigational Site
Thessaloniki, Greece, 54642
GSK Investigational Site
Thessaloniki, Greece, 564 29
Hungary
GSK Investigational Site
Budapest, Hungary, 1023
GSK Investigational Site
Budapest, Hungary, 1238
GSK Investigational Site
Budapest, Hungary
GSK Investigational Site
Győr, Hungary, 9024
India
GSK Investigational Site
Bangalore, India, 560 017
GSK Investigational Site
Bangalore, India, 560 054
GSK Investigational Site
Bangalore, India, 560034
GSK Investigational Site
Chennai, India, 600003
GSK Investigational Site
Hyderabad, Andhra Pradesh, India, 500482
GSK Investigational Site
Hyderabad, India, 500 004
GSK Investigational Site
New Delhi, India
GSK Investigational Site
Pune., India, 411 001
Ireland
GSK Investigational Site
Dublin, Ireland, 9
GSK Investigational Site
Waterford, Ireland
Italy
GSK Investigational Site
Pescara, Abruzzo, Italy, 65100
GSK Investigational Site
Benevento, Campania, Italy, 82100
GSK Investigational Site
Telese Terme (BN), Campania, Italy, 82100
GSK Investigational Site
Arenzano (GE), Liguria, Italy, 16011
GSK Investigational Site
Genova, Liguria, Italy, 16148
GSK Investigational Site
Rozzano (MI), Lombardia, Italy, 20089
GSK Investigational Site
Pisa, Toscana, Italy, 56126
GSK Investigational Site
Prato, Toscana, Italy, 59100
GSK Investigational Site
Terni, Umbria, Italy, 05100
GSK Investigational Site
Montebelluna (TV), Veneto, Italy, 31044
Korea, Republic of
GSK Investigational Site
Anyang-Si, Korea, Republic of, 431-070
GSK Investigational Site
Daegu, Korea, Republic of, 705-718
GSK Investigational Site
Seoul, Korea, Republic of, 110-744
GSK Investigational Site
Seoul, Korea, Republic of, 120-752
GSK Investigational Site
Seoul, Korea, Republic of, 138-736
GSK Investigational Site
Seoul, Korea, Republic of
Latvia
GSK Investigational Site
Liepaja, Latvia, LV3400
GSK Investigational Site
Riga, Latvia, LV 1002
GSK Investigational Site
Riga, Latvia, LV1079
GSK Investigational Site
Valmiera, Latvia
Mexico
GSK Investigational Site
Guadalajara, Jalisco, Mexico, 44280
GSK Investigational Site
Guadalajara, Jalisco, Mexico, 44340
GSK Investigational Site
Monterrey, Nuevo León, Mexico, 64020
GSK Investigational Site
Mexico, D.F., Mexico, 06720
GSK Investigational Site
Mexico, Mexico, 06700
GSK Investigational Site
Mexico, Mexico
Netherlands
GSK Investigational Site
Den Haag, Netherlands, 2597 AX
GSK Investigational Site
Etten-leur, Netherlands, 4872 LA
GSK Investigational Site
Gouda, Netherlands, 2803 HH
GSK Investigational Site
Heerlen, Netherlands, 6416 EG
GSK Investigational Site
Nijmegen, Netherlands, 6525 GA
GSK Investigational Site
Zwolle, Netherlands, 8011 JW
New Zealand
GSK Investigational Site
Auckland, New Zealand, 1309
GSK Investigational Site
Auckland, New Zealand, 1701
GSK Investigational Site
Christchurch, New Zealand, 8001
GSK Investigational Site
Lower Hutt, New Zealand, 6009
GSK Investigational Site
Rotorua, New Zealand, 3201
Norway
GSK Investigational Site
Harstad, Norway, 9480
GSK Investigational Site
Levanger, Norway, 7600
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Lillehammer, Norway, 2609
GSK Investigational Site
Skien, Norway, 3722
GSK Investigational Site
Tønsberg, Norway, N-3117
Peru
GSK Investigational Site
Callao, Peru, Callao 2
GSK Investigational Site
Lima, Peru, Lima 27
GSK Investigational Site
Lima, Peru, Lima 39
Philippines
GSK Investigational Site
Manila, Philippines, 1000
GSK Investigational Site
Manila, Philippines, 1003
Poland
GSK Investigational Site
Grudziadz, Poland, 86-300
GSK Investigational Site
Poznan, Poland, 61-544
GSK Investigational Site
Warszawa, Poland, 02-341
GSK Investigational Site
Wroclaw, Poland, 50-044
GSK Investigational Site
Wroclaw, Poland, 50-088
Puerto Rico
GSK Investigational Site
Caguas, Puerto Rico, 00726
Romania
GSK Investigational Site
Brasov, Romania, 500366
GSK Investigational Site
Bucharest, Romania, 11172
GSK Investigational Site
Bucharest, Romania, 20983
GSK Investigational Site
Bucharest, Romania
Russian Federation
GSK Investigational Site
Ekaterinburg, Russian Federation, 620102
GSK Investigational Site
Moscow, Russian Federation, 115522
GSK Investigational Site
Moscow, Russian Federation, 119049
GSK Investigational Site
Moscow, Russian Federation, 129327
GSK Investigational Site
Moscow, Russian Federation
GSK Investigational Site
Ryazan, Russian Federation, 390026
GSK Investigational Site
Sankt-Petersburg, Russian Federation
GSK Investigational Site
Saratov, Russian Federation, 410053
GSK Investigational Site
St. Petersburg, Russian Federation
GSK Investigational Site
Tula, Russian Federation, 300053
GSK Investigational Site
Yaroslavl, Russian Federation, 150003
GSK Investigational Site
Yaroslavl, Russian Federation, 150062
South Africa
GSK Investigational Site
Korsten, Eastern Cape, South Africa, 6020
GSK Investigational Site
Boksburg, Gauteng, South Africa
GSK Investigational Site
Muckleneuk, Gauteng, South Africa, 0001
GSK Investigational Site
Parktown, Gauteng, South Africa, 2193
GSK Investigational Site
Cape Town, South Africa, 7525
GSK Investigational Site
Durban, South Africa, 4001
GSK Investigational Site
Erasmus Kloof, Pretoria, South Africa, 0048
GSK Investigational Site
Kempton Park, South Africa, 1619
GSK Investigational Site
Observatory, South Africa, 7925
GSK Investigational Site
Pinetown, South Africa, 7405
Spain
GSK Investigational Site
Baracaldo/Vizcaya, Spain, 48903
GSK Investigational Site
Barcelona, Spain, 08003
GSK Investigational Site
Barcelona, Spain, 08025
GSK Investigational Site
Barcelona, Spain, 08035
GSK Investigational Site
Cordoba, Spain, 14004
GSK Investigational Site
Granada, Spain, 18014
GSK Investigational Site
Guadalajara, Spain, 19002
GSK Investigational Site
La Coruña, Spain, 15006
GSK Investigational Site
Mérida (Badajoz), Spain, 06800
GSK Investigational Site
Oviedo, Spain, 33006
GSK Investigational Site
Pamplona, Spain, 31008
GSK Investigational Site
San Sebastián, Spain, 20014
GSK Investigational Site
Santiago de Compostela, Spain, 15706
GSK Investigational Site
Sevilla, Spain, 41071
GSK Investigational Site
Valencia, Spain, 46017
GSK Investigational Site
Villajoyosa, Spain, 3570
Ukraine
GSK Investigational Site
Kharkiv, Ukraine, 61002
GSK Investigational Site
Kharkiv, Ukraine, 61039
GSK Investigational Site
Kiev, Ukraine
GSK Investigational Site
Kyiv, Ukraine, 03680
GSK Investigational Site
Lviv, Ukraine, 79010
United Kingdom
GSK Investigational Site
Truro, Cornwall, United Kingdom, TR1 3LJ
GSK Investigational Site
St Albans, Hertfordshire, United Kingdom, AL3 5PN
GSK Investigational Site
Manchester, Lancashire, United Kingdom, M13 9WL
GSK Investigational Site
Wirral, Merseyside, United Kingdom, CH49 9PE
GSK Investigational Site
Ashford, Middlesex, United Kingdom, TW15 3AA
GSK Investigational Site
Northampton, Northamptonshire, United Kingdom, NN1 5BD
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00113308     History of Changes
Other Study ID Numbers: CXA30009
First Posted: June 8, 2005    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017

Keywords provided by GlaxoSmithKline:
Rheumatoid Arthritis
COX-2 Inhibitor

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents