AzTrials
AzTrials

Arthritis, RheumatoidPhase 3NCT00113308

COX-2 Inhibitor Study In Patients With Rheumatoid Arthritis

A Phase 3 study testing GW406381 in people with Arthritis, Rheumatoid, run by GlaxoSmithKline at 341 sites in 33 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is being conducted to find out if an investigational drug called GW406381 can help people with rheumatoid arthritis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arthritis, Rheumatoid
What is being tested?
GW406381
How many people
2,208 participants
Where
341 sitesin 33 countries
Study dates
Jun 2005to Sep 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

341 sites in 33 countries.

341 sites in 33 countries

United States105 sites

  • GSK Investigational Site

    Anaheim, California, 92801

  • GSK Investigational Site

    Anniston, Alabama, 36207

  • GSK Investigational Site

    Atlanta, Georgia, 30342

  • GSK Investigational Site

    Austin, Texas, 78705

  • GSK Investigational Site

    Aventura, Florida, 33180

  • GSK Investigational Site

    Berlin, New Jersey, 08009

  • GSK Investigational Site

    Birmingham, Alabama, 35205

  • GSK Investigational Site

    Birmingham, Alabama, 35215

  • GSK Investigational Site

    Bridgeport, Connecticut, 06606

  • GSK Investigational Site

    Charleston, South Carolina, 29406

  • GSK Investigational Site

    Charleston, South Carolina, 29407

  • GSK Investigational Site

    Charlotte, North Carolina, 28210

  • GSK Investigational Site

    Cleveland, Ohio, 44130

  • GSK Investigational Site

    Colorado Springs, Colorado, 80909

  • GSK Investigational Site

    Columbus, Ohio, 43210

  • GSK Investigational Site

    Concinnati, Ohio, 45219

  • GSK Investigational Site

    Dallas, Texas, 75231

  • GSK Investigational Site

    Danbury, Connecticut, 06810

  • GSK Investigational Site

    Daytona Beach, Florida, 32114

  • GSK Investigational Site

    DeLand, Florida, 32720

  • GSK Investigational Site

    Dover, New Hampshire, 03820

  • GSK Investigational Site

    Duncansville, Pennsylvania, 16635

  • GSK Investigational Site

    Dunedin, Florida, 34698

  • GSK Investigational Site

    Evanston, Illinois, 60201

  • GSK Investigational Site

    Evansville, Indiana, 47714

  • GSK Investigational Site

    Everett, Washington, 98201

  • GSK Investigational Site

    Fall River, Massachusetts, 02720

  • GSK Investigational Site

    Gainsville, Georgia, 30501

  • GSK Investigational Site

    Gastonia, North Carolina, 28054

  • GSK Investigational Site

    Glendale, Arizona, 85308

  • GSK Investigational Site

    Greer, South Carolina, 29651

  • GSK Investigational Site

    Hamden, Connecticut, 06518

  • GSK Investigational Site

    Hampton, South Carolina, 29924

  • GSK Investigational Site

    Hickory, North Carolina, 28601

  • GSK Investigational Site

    Huntsville, Alabama, 35801

  • GSK Investigational Site

    Idaho Falls, Idaho, 83401

  • GSK Investigational Site

    Indianapolis, Indiana, 46202

  • GSK Investigational Site

    Indianapolis, Indiana, 46227

  • GSK Investigational Site

    Johnson City, New York, 13790

  • GSK Investigational Site

    Kalamazoo, Michigan, 49048

  • GSK Investigational Site

    Kingston, New York, 12401

  • GSK Investigational Site

    Lansing, Michigan, 48910

  • GSK Investigational Site

    Largo, Florida, 33773

  • GSK Investigational Site

    Las Vegas, Nevada, 89103

  • GSK Investigational Site

    Las Vegas, Nevada, 89106

  • GSK Investigational Site

    Las Vegas, Nevada, 89128

  • GSK Investigational Site

    Louisville, Kentucky, 40202

  • GSK Investigational Site

    Louisville, Kentucky, 40207

  • GSK Investigational Site

    Louisville, Kentucky, 40213

  • GSK Investigational Site

    Mayfield Village, Ohio, 44143

  • GSK Investigational Site

    Medford, Oregon, 97504

  • GSK Investigational Site

    Memphis, Tennessee, 38119

  • GSK Investigational Site

    Mercerville, New Jersey, 08619

  • GSK Investigational Site

    Miami, Florida, 33156

  • GSK Investigational Site

    Miami, Florida, 33173

  • GSK Investigational Site

    Montgomery, Alabama, 36106

  • GSK Investigational Site

    Montgomery, Alabama, 36111

  • GSK Investigational Site

    Morton Grove, Illinois, 60053

  • GSK Investigational Site

    Murrells Inlet, South Carolina, 29576

  • GSK Investigational Site

    New Orleans, Louisiana, 70115

  • GSK Investigational Site

    New York, New York, 10024

  • GSK Investigational Site

    North Massapequa, New York, 11758

  • GSK Investigational Site

    Ocala, Florida, 34474

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73112

  • GSK Investigational Site

    Orlando, Florida, 32804

  • GSK Investigational Site

    Orlando, Florida, 32806

  • GSK Investigational Site

    Palm Desert, California, 92260

  • GSK Investigational Site

    Palm Harbor, Florida, 34684

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19118

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19140

  • GSK Investigational Site

    Port Orange, Florida, 32127

  • GSK Investigational Site

    Prairie Village, Kansas, 66206

  • GSK Investigational Site

    Racine, Wisconsin, 53404

  • GSK Investigational Site

    Reno, Nevada, 89502

  • GSK Investigational Site

    Rochester, New York, 14618

  • GSK Investigational Site

    Roswell, Georgia, 30075

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    San Antonio, Texas, 78232

  • GSK Investigational Site

    San Diego, California, 92103-6204

  • GSK Investigational Site

    San Diego, California, 92108

  • GSK Investigational Site

    San Diego, California, 92128

  • GSK Investigational Site

    Santa Monica, California, 90048

  • GSK Investigational Site

    Scottsdale, Arizona, 85251

  • GSK Investigational Site

    Slidell, Louisiana, 70458

  • GSK Investigational Site

    Springfield, Illinois, 62704

  • GSK Investigational Site

    Springfield, Massachusetts, 01107

  • GSK Investigational Site

    St Louis, Missouri, 63117

  • GSK Investigational Site

    St Louis, Missouri, 63141

  • GSK Investigational Site

    Statesville, North Carolina, 28625

  • GSK Investigational Site

    Stuart, Florida, 34996

  • GSK Investigational Site

    Tampa, Florida, 33614

  • GSK Investigational Site

    Trinity, Florida, 34655

  • GSK Investigational Site

    Trumbull, Connecticut, 06611

  • GSK Investigational Site

    Tucson, Arizona, 85704

  • GSK Investigational Site

    Tucson, Arizona, 85719

  • GSK Investigational Site

    Tulsa, Oklahoma, 74104

  • GSK Investigational Site

    Tulsa, Oklahoma, 74135

  • GSK Investigational Site

    Upland, California, 91786

  • GSK Investigational Site

    Vancouver, Washington, 98664

  • GSK Investigational Site

    West Palm Beach, Florida, 33409

  • GSK Investigational Site

    West Reading, Pennsylvania, 19611

  • GSK Investigational Site

    Wheaton, Maryland, 20902

  • GSK Investigational Site

    Wichita, Kansas, 67207

  • GSK Investigational Site

    Woodstock, Georgia, 30189

  • GSK Investigational Site

    Zephyrhills, Florida, 33540

Other trials in United States

Germany50 sites

  • GSK Investigational Site

    Aachen, North Rhine-Westphalia, 52064

  • GSK Investigational Site

    Baden-Baden, Baden-Wurttemberg, 76530

  • GSK Investigational Site

    Bayreuth, Bavaria, 95445

  • GSK Investigational Site

    Beckum, North Rhine-Westphalia, 59269

  • GSK Investigational Site

    Berlin, State of Berlin, 10777

  • GSK Investigational Site

    Berlin, State of Berlin, 12247

  • GSK Investigational Site

    Berlin, State of Berlin, 13125

  • GSK Investigational Site

    Berlin, State of Berlin, 14057

  • GSK Investigational Site

    Berlin, State of Berlin, 14109

  • GSK Investigational Site

    Bochum, North Rhine-Westphalia, 44787

  • GSK Investigational Site

    Chemnitz, Saxony, 09111

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 51069

  • GSK Investigational Site

    Deggingen, Baden-Wurttemberg, 73326

  • GSK Investigational Site

    Delitzsch, Saxony, 04509

  • GSK Investigational Site

    Dresden, Saxony, 01067

  • GSK Investigational Site

    Einbeck, Lower Saxony, 37574

  • GSK Investigational Site

    Elmshorn, Schleswig-Holstein, 25335

  • GSK Investigational Site

    Erlangen, Bavaria, 91054

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45326

  • GSK Investigational Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79098

  • GSK Investigational Site

    Freital, Saxony, 01705

  • GSK Investigational Site

    Goch, North Rhine-Westphalia, 47574

  • GSK Investigational Site

    Görlitz, Saxony, 02826

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 20249

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 22143

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 22415

  • GSK Investigational Site

    Hanover, Lower Saxony, 30519

  • GSK Investigational Site

    Hattingen, North Rhine-Westphalia, 45525

  • GSK Investigational Site

    Hildesheim, Lower Saxony, 31134

  • GSK Investigational Site

    Hüttenberg, Hesse, 35625

  • GSK Investigational Site

    Kippenheim, Baden-Wurttemberg, 77971

  • GSK Investigational Site

    Leipzig, Saxony, 04107

  • GSK Investigational Site

    Leipzig, Saxony, 04229

  • GSK Investigational Site

    Lübeck, Schleswig-Holstein, 23538

  • GSK Investigational Site

    Munich, Bavaria, 80333

  • GSK Investigational Site

    Munich, Bavaria, 80339

  • GSK Investigational Site

    Münster, North Rhine-Westphalia, 48155

  • GSK Investigational Site

    Nuremberg, Bavaria, 90402

  • GSK Investigational Site

    Passau, Bavaria, 94032

  • GSK Investigational Site

    Pinneberg, Schleswig-Holstein, 25421

  • GSK Investigational Site

    Rhaunen, Rhineland-Palatinate, 55624

  • GSK Investigational Site

    Saarbrücken, Saarland, 66111

  • GSK Investigational Site

    Schmiedeberg, Saxony, 01762

  • GSK Investigational Site

    Schwerin, Mecklenburg-Vorpommern, 19055

  • GSK Investigational Site

    Stuttgart, Baden-Wurttemberg, 66111

  • GSK Investigational Site

    Stuttgart, Baden-Wurttemberg, 70469

  • GSK Investigational Site

    Weinheim, Baden-Wurttemberg, 69469

  • GSK Investigational Site

    Wiesbaden, Hesse, 65185

  • GSK Investigational Site

    Witten, North Rhine-Westphalia, 58455

  • GSK Investigational Site

    Wolmirstedt, Saxony-Anhalt, 39326

Other trials in Germany

Canada17 sites

  • GSK Investigational Site

    Edmonton, Alberta, T5K 2A2

  • GSK Investigational Site

    Kitchener, Ontario, N2M 5N6

  • GSK Investigational Site

    Mississauga, Ontario, L5M 2V8

  • GSK Investigational Site

    Montreal, Quebec, H3T 1E2

  • GSK Investigational Site

    Montreal, Quebec, H3Z 2Z3

  • GSK Investigational Site

    Penticton, British Columbia, V2A 3G8

  • GSK Investigational Site

    Saint-Jérôme, Quebec, J7Z 5T3

  • GSK Investigational Site

    Sainte-Foy, Quebec, G1W 4R4

  • GSK Investigational Site

    Saskatoon, Saskatchewan, S7N 0W8

  • GSK Investigational Site

    St. John's, Newfoundland and Labrador, A1B 3E1

  • GSK Investigational Site

    Toronto, Ontario, M4N 3M5

  • GSK Investigational Site

    Toronto, Ontario, M5T 2S8

  • GSK Investigational Site

    Toronto, Ontario, M9W 4L6

  • GSK Investigational Site

    Trois-Rivières, Quebec, G8Z 1Y2

  • GSK Investigational Site

    Victoria, British Columbia, V8P 5P6

  • GSK Investigational Site

    Windsor, Ontario, N8X 5A6

  • GSK Investigational Site

    Winnipeg, Manitoba, R3A 1M3

Other trials in Canada

Spain16 sites

  • GSK Investigational Site

    A Coruña, 15006

  • GSK Investigational Site

    Baracaldo/Vizcaya, 48903

  • GSK Investigational Site

    Barcelona, 08003

  • GSK Investigational Site

    Barcelona, 08025

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    Córdoba, 14004

  • GSK Investigational Site

    Granada, 18014

  • GSK Investigational Site

    Guadalajara, 19002

  • GSK Investigational Site

    Mérida (Badajoz), 06800

  • GSK Investigational Site

    Oviedo, 33006

  • GSK Investigational Site

    Pamplona, 31008

  • GSK Investigational Site

    San Sebastián, 20014

  • GSK Investigational Site

    Santiago de Compostela, 15706

  • GSK Investigational Site

    Seville, 41071

  • GSK Investigational Site

    Valencia, 46017

  • GSK Investigational Site

    Villajoyosa, 3570

Other trials in Spain

Argentina12 sites

  • GSK Investigational Site

    Buenos Aires, 1013

  • GSK Investigational Site

    Buenos Aires, 1427

  • GSK Investigational Site

    Buenos Aires, C1121ABE

  • GSK Investigational Site

    Buenos Aires, C1128AAF

  • GSK Investigational Site

    Buenos Aires, C1426BOR

  • GSK Investigational Site

    Córdoba, Córdoba Province, 5000

  • GSK Investigational Site

    Córdoba, Córdoba Province

  • GSK Investigational Site

    Córdoba, 5000

  • GSK Investigational Site

    Quilmes, 1878

  • GSK Investigational Site

    Rosario, Santa Fe Province, 2000

  • GSK Investigational Site

    San Juan, 5400

  • GSK Investigational Site

    San Miguel de Tucumán, 4000

Other trials in Argentina

Russia11 sites

  • GSK Investigational Site

    Moscow, 115522

  • GSK Investigational Site

    Moscow, 119049

  • GSK Investigational Site

    Moscow, 129327

  • GSK Investigational Site

    Moscow

  • GSK Investigational Site

    Ryazan, 390026

  • GSK Investigational Site

    Saint Petersburg

  • GSK Investigational Site

    Saratov, 410053

  • GSK Investigational Site

    Tula, 300053

  • GSK Investigational Site

    Yaroslavl, 150003

  • GSK Investigational Site

    Yaroslavl, 150062

  • GSK Investigational Site

    Yekaterinburg, 620102

Other trials in Russia

Italy10 sites

  • GSK Investigational Site

    Arenzano (GE), Liguria, 16011

  • GSK Investigational Site

    Benevento, Campania, 82100

  • GSK Investigational Site

    Genoa, Liguria, 16148

  • GSK Investigational Site

    Montebelluna (TV), Veneto, 31044

  • GSK Investigational Site

    Pescara, Abruzzo, 65100

  • GSK Investigational Site

    Pisa, Tuscany, 56126

  • GSK Investigational Site

    Prato, Tuscany, 59100

  • GSK Investigational Site

    Rozzano (MI), Lombardy, 20089

  • GSK Investigational Site

    Telese Terme (BN), Campania, 82100

  • GSK Investigational Site

    Terni, Umbria, 05100

Other trials in Italy

South Africa10 sites

  • GSK Investigational Site

    Boksburg, Gauteng

  • GSK Investigational Site

    Cape Town, 7525

  • GSK Investigational Site

    Durban, 4001

  • GSK Investigational Site

    Erasmus Kloof, Pretoria, 0048

  • GSK Investigational Site

    Kempton Park, 1619

  • GSK Investigational Site

    Korsten, Eastern Cape, 6020

  • GSK Investigational Site

    Muckleneuk, Gauteng, 0001

  • GSK Investigational Site

    Observatory, 7925

  • GSK Investigational Site

    Parktown, Gauteng, 2193

  • GSK Investigational Site

    Pinetown, 7405

Other trials in South Africa

France9 sites

  • GSK Investigational Site

    Angers, 49100

  • GSK Investigational Site

    Cahors, 46005

  • GSK Investigational Site

    Chilly-Mazarin, 91380

  • GSK Investigational Site

    Corbeil-Essonnes, 91106

  • GSK Investigational Site

    Grenoble, 38042

  • GSK Investigational Site

    Lyon, 69002

  • GSK Investigational Site

    Paris, 75571

  • GSK Investigational Site

    Toulouse, 31300

  • GSK Investigational Site

    Tours, 37000

Other trials in France

India8 sites

  • GSK Investigational Site

    Bangalore, 560 017

  • GSK Investigational Site

    Bangalore, 560 054

  • GSK Investigational Site

    Bangalore, 560034

  • GSK Investigational Site

    Chennai, 600003

  • GSK Investigational Site

    Hyderabad, 500 004

  • GSK Investigational Site

    Hyderabad, Andhra Pradesh, 500482

  • GSK Investigational Site

    New Delhi

  • GSK Investigational Site

    Pune, 411 001

Other trials in India

Mexico6 sites

  • GSK Investigational Site

    Guadalajara, Jalisco, 44280

  • GSK Investigational Site

    Guadalajara, Jalisco, 44340

  • GSK Investigational Site

    México, 06700

  • GSK Investigational Site

    México

  • GSK Investigational Site

    Mexico City, 06720

  • GSK Investigational Site

    Monterrey, Nuevo León, 64020

Other trials in Mexico

Netherlands6 sites

  • GSK Investigational Site

    Etten-Leur, 4872 LA

  • GSK Investigational Site

    Gouda, 2803 HH

  • GSK Investigational Site

    Heerlen, 6416 EG

  • GSK Investigational Site

    Nijmegen, 6525 GA

  • GSK Investigational Site

    The Hague, 2597 AX

  • GSK Investigational Site

    Zwolle, 8011 JW

Other trials in Netherlands

South Korea6 sites

  • GSK Investigational Site

    Anyang-si, 431-070

  • GSK Investigational Site

    Daegu, 705-718

  • GSK Investigational Site

    Seoul, 110-744

  • GSK Investigational Site

    Seoul, 120-752

  • GSK Investigational Site

    Seoul, 138-736

  • GSK Investigational Site

    Seoul

Other trials in South Korea

United Kingdom6 sites

  • GSK Investigational Site

    Ashford, Middlesex, TW15 3AA

  • GSK Investigational Site

    Manchester, Lancashire, M13 9WL

  • GSK Investigational Site

    Metropolitan Borough of Wirral, Merseyside, CH49 9PE

  • GSK Investigational Site

    Northampton, Northamptonshire, NN1 5BD

  • GSK Investigational Site

    St Albans, Hertfordshire, AL3 5PN

  • GSK Investigational Site

    Truro, Cornwall, TR1 3LJ

Other trials in United Kingdom

Bulgaria5 sites

  • GSK Investigational Site

    Pleven, 5800

  • GSK Investigational Site

    Sofia, 1233

  • GSK Investigational Site

    Sofia, 1431/1000

  • GSK Investigational Site

    Sofia, 1431

  • GSK Investigational Site

    Varna, 9010

Other trials in Bulgaria

New Zealand5 sites

  • GSK Investigational Site

    Auckland, 1309

  • GSK Investigational Site

    Auckland, 1701

  • GSK Investigational Site

    Christchurch, 8001

  • GSK Investigational Site

    Lower Hutt, 6009

  • GSK Investigational Site

    Rotorua, 3201

Other trials in New Zealand

Norway5 sites

  • GSK Investigational Site

    Harstad, 9480

  • GSK Investigational Site

    Levanger, 7600

  • GSK Investigational Site

    Lillehammer, 2609

  • GSK Investigational Site

    Skien, 3722

  • GSK Investigational Site

    Tønsberg, N-3117

Other trials in Norway

Poland5 sites

  • GSK Investigational Site

    Grudziądz, 86-300

  • GSK Investigational Site

    Poznan, 61-544

  • GSK Investigational Site

    Warsaw, 02-341

  • GSK Investigational Site

    Wroclaw, 50-044

  • GSK Investigational Site

    Wroclaw, 50-088

Other trials in Poland

Ukraine5 sites

  • GSK Investigational Site

    Kharkiv, 61002

  • GSK Investigational Site

    Kharkiv, 61039

  • GSK Investigational Site

    Kiev

  • GSK Investigational Site

    Kyiv, 03680

  • GSK Investigational Site

    Lviv, 79010

Other trials in Ukraine

Austria4 sites

  • GSK Investigational Site

    Vienna, A-1021

  • GSK Investigational Site

    Vienna, A-1060

  • GSK Investigational Site

    Vienna, A-1090

  • GSK Investigational Site

    Vienna, A-1100

Other trials in Austria

Belgium4 sites

  • GSK Investigational Site

    Antwerp, 2020

  • GSK Investigational Site

    Diepenbeek, 3590

  • GSK Investigational Site

    Lommel, 3920

  • GSK Investigational Site

    Mons, 7000

Other trials in Belgium

Denmark4 sites

  • GSK Investigational Site

    Aalborg, 9000

  • GSK Investigational Site

    Ishøj, 2635

  • GSK Investigational Site

    Odense C, 5000

  • GSK Investigational Site

    Vejle, 7100

Other trials in Denmark

Greece4 sites

  • GSK Investigational Site

    Kavala, 65403

  • GSK Investigational Site

    Thessaloniki, 546 36

  • GSK Investigational Site

    Thessaloniki, 54642

  • GSK Investigational Site

    Thessaloniki, 564 29

Other trials in Greece

Hungary4 sites

  • GSK Investigational Site

    Budapest, 1023

  • GSK Investigational Site

    Budapest, 1238

  • GSK Investigational Site

    Budapest

  • GSK Investigational Site

    Győr, 9024

Other trials in Hungary

Latvia4 sites

  • GSK Investigational Site

    Liepāja, LV3400

  • GSK Investigational Site

    Riga, LV 1002

  • GSK Investigational Site

    Riga, LV1079

  • GSK Investigational Site

    Valmiera

Other trials in Latvia

Peru4 sites

  • GSK Investigational Site

    Callao, Callao 2

  • GSK Investigational Site

    Lima, Lima Province, Lima 27

  • GSK Investigational Site

    Lima, Lima 27

  • GSK Investigational Site

    Lima, Lima 39

Other trials in Peru

Romania4 sites

  • GSK Investigational Site

    Brasov, 500366

  • GSK Investigational Site

    Bucharest, 11172

  • GSK Investigational Site

    Bucharest, 20983

  • GSK Investigational Site

    Bucharest

Other trials in Romania

Chile3 sites

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 8380456

  • GSK Investigational Site

    Santiago, Región Metro de Santiago

  • GSK Investigational Site

    Viña del Mar, Valparaiso

Other trials in Chile

Finland3 sites

  • GSK Investigational Site

    Helsinki, 00100

  • GSK Investigational Site

    Hyvinkää, 05800

  • GSK Investigational Site

    Kuopio, 70100

Other trials in Finland

Ireland2 sites

  • GSK Investigational Site

    Dublin, 9

  • GSK Investigational Site

    Waterford

Other trials in Ireland

Philippines2 sites

  • GSK Investigational Site

    Manila, 1000

  • GSK Investigational Site

    Manila, 1003

Other trials in Philippines

Costa Rica1 site

  • GSK Investigational Site

    San José

Other trials in Costa Rica

Puerto Rico1 site

  • GSK Investigational Site

    Caguas, Puerto Rico, 00726

Other trials in Puerto Rico

About this study

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

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

Being tested
GW406381
Keywords
Rheumatoid Arthritis, COX-2 Inhibitor
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GW406381Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of American College of Rheumatology (ACR)20 Responders at Week 12

    Measured: Week 12

Secondary outcomes (32)

  1. Change from baseline to each scheduled visit in tender/painful joint count (68 joint panel)

    Measured: Baseline and Week 12

  2. Change from baseline to each scheduled visit in swollen joint count (66 joint panel)

    Measured: Baseline and Week 12

  3. Change from baseline to each scheduled visit in patient's pain assessment (VAS)

    Measured: Baseline and Week 12

  4. Change from baseline to each scheduled visit in physician's global assessment of arthritis condition

    Measured: Baseline and Week 12

  5. Change from baseline to each scheduled visit in patient's global assessment of arthritis condition

    Measured: Baseline and Week 12

  6. Change from baseline to each scheduled visit in functional disability index (HAQ)

    Measured: Baseline and Week 12

  7. Change between baseline and end of treatment (or early withdrawal) in the Short Form - McGill Pain Questionnaire (SF-MPQ)

    Measured: Baseline and Up to Week 12

  8. Change from baseline to each scheduled visit in C-reactive protein (CRP)

    Measured: Baseline and up to Week 12

  9. Number of participants withdrawing from the study due to lack of efficacy

    Measured: Week 12

  10. Number of participants who received supplementary analgesic therapy

    Measured: 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)

    Measured: Baseline and up to Week 12

  12. Changes from pretreatment to on treatment and post-treatment follow-up in vital signs- heart rate (HR)

    Measured: Baseline and up to Week 12

  13. Changes from pretreatment to on treatment and post-treatment follow-up in weight

    Measured: Baseline and Week 12

  14. Number of participants with change in BMI of potential clinical concern

    Measured: Week 4, 4, 8, 12 and foloow up

  15. Number of participants with change from baseline of pedal oedema (including diuretic use)

    Measured: Baseline and up to Week 12

  16. Change from baseline in 12-lead electrocardiograms (ECGs)

    Measured: Baseline and up to Week 12

  17. Change from baseline in clinical chemistry parameters: Albumin

    Measured: Baseline and up to Week 12

  18. Change from baseline in clinical chemistry parameters: Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase

    Measured: Baseline and Up to Week 12

  19. Change from baseline in clinical chemistry parameters: Total Bilirubin

    Measured: Baseline and up to Week 12

  20. Change from baseline in clinical chemistry parameters: Carbon Dioxide content /Bicarbonate, Glucose, Potassium, Sodium

    Measured: Baseline and up to Week 12

  21. Change from baseline in clinical chemistry parameters: Creatinine

    Measured: 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

    Measured: Baseline and up to Week 12

  23. Change from baseline in haematology parameters: Hemoglobin

    Measured: Baseline and up to Week 12

  24. Change from baseline in haematology parameters: Mean Corpuscle volume

    Measured: Baseline and Up to Week 12

  25. Change from baseline in haematology parameters: Red Blood Cell count

    Measured: Baseline and up to Week 12

  26. Urinalysis assessment

    Measured: Up to Week 12

  27. Number of participants with adverse events (AEs) and serious adverse events (SAEs)

    Measured: Upto Week 12

  28. Change in the Short Form-36 (SF-36v2) subscale scores between baseline and the end of treatment (or early withdrawal)

    Measured: 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)

    Measured: Baseline and Week 12

  30. Psychometrically test and validate the amended Patient Satisfaction with Pain Medication questionnaire

    Measured: 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

    Measured: 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)

    Measured: Baseline and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2005 (estimated)
  2. Study startJun 2005
  3. Primary completionSep 2006
  4. Study completionSep 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
2,208 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00113308
Sponsor's protocol ID
CXA30009
Status last verified
Mar 2017
First submitted
7 Jun 2005
Last updated
14 Mar 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GW406381 in people with Arthritis, Rheumatoid, run by GlaxoSmithKline at 341 sites in 33 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 341 sites in United States, Germany, Canada, Spain, Argentina and 28 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of American College of Rheumatology (ACR)20 Responders at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00113308.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2017.

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