Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis

Condition(s) targeted: Osteoarthritis; Arthritis, Rheumatoid

Intervention: Celecoxib (Drug); Diclofenac + Omeprazole (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

To determine whether celecoxib is superior to combined therapy with diclofenac and omeprazole in the incidence of clinically significant upper and/or lower gastrointestinal (GI) events in high GI risk subjects with osteoarthritis and/or rheumatoid arthritis.

Official title: Double-Blind, Triple Dummy, Parallel-Group, Randomized, Six-Month Study To Compare Celecoxib (200 Mg BID) With Diclofenac Sr (75 Mg BID) Plus Omeprazole (20 Mg QD) For Gastrointestinal Events In Subjects With Osteoarthritis And Rheumatoid Arthritis At High-Risk Of Gastrointestinal Adverse Events

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome:

any event that in clinical practice would impact the subject in terms of inpatient/outpatient investigation for GI pathology with blood loss or other serious complication

The incidence of clinically significant upper and/or lower GI events (CSULGIEs)

Secondary outcome:

CSULGIEs plus symptomatic ulcers (SUs)

Incidence of: CSULGIEs, SUs moderate to severe abdominal symptoms, withdrawal due to GI AEs, clinically significant decrease Hct and/or Hb

Hepatic AEs in GGT, AST or ALT of 3xULN

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects with a clinical diagnosis of OA or RA and who are expected to require regular

anti-inflammatory therapy for arthritis symptom management

- Subjects must be aged 60 years or older with or without a history of gastroduodenal

(GD) ulceration; or be of any age 18 years or older and have had documented evidence of GD ulceration 90 days or more prior to the screening visit

Exclusion Criteria:

- Active GD ulceration or GD ulceration within 90 days of the screening visit.

- Concomitant use of low dose aspirin

- Previous MI, stroke or significant vascular disease.

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Genk 3600, Belgium; Completed

Pfizer Investigational Site, Liège 4000, Belgium; Completed

Pfizer Investigational Site, Gent 9000, Belgium; Completed

Pfizer Investigational Site, Hasselt 3500, Belgium; Active, not recruiting

Pfizer Investigational Site, Beijing 100073, China; Active, not recruiting

Pfizer Investigational Site, Beijing 100044, China; Active, not recruiting

Pfizer Investigational Site, Shanghai 200001, China; Active, not recruiting

Pfizer Investigational Site, Shanghai 200040, China; Active, not recruiting

Pfizer Investigational Site, Tianjin 300052, China; Active, not recruiting

Pfizer Investigational Site, Tianjin 300192, China; Active, not recruiting

Pfizer Investigational Site, Beijing 100020, China; Active, not recruiting

Pfizer Investigational Site, Beijing 100853, China; Active, not recruiting

Pfizer Investigational Site, San Jose, Costa Rica; Active, not recruiting

Pfizer Investigational Site, Heredia, Costa Rica; Active, not recruiting

Pfizer Investigational Site, Cartago, Costa Rica; Active, not recruiting

Pfizer Investigational Site, San Jose 3er piso., Costa Rica; Active, not recruiting

Pfizer Investigational Site, Zagreb 10000, Croatia; Active, not recruiting

Pfizer Investigational Site, Opatija 51410, Croatia; Active, not recruiting

Pfizer Investigational Site, Ceske Budejovice 370 01, Czech Republic; Completed

Pfizer Investigational Site, Hradec Kralove 50012, Czech Republic; Completed

Pfizer Investigational Site, Praha 2 120 00, Czech Republic; Active, not recruiting

Pfizer Investigational Site, Praha 2 128 50, Czech Republic; Active, not recruiting

Pfizer Investigational Site, Praha 6 16900, Czech Republic; Active, not recruiting

Pfizer Investigational Site, Praha 4 140 59, Czech Republic; Completed

Pfizer Investigational Site, Prague 1 118 00, Czech Republic; Completed

Pfizer Investigational Site, Praha 2 120 00, Czech Republic; Completed

Pfizer Investigational Site, Guayaquil, Ecuador; Completed

Pfizer Investigational Site, Tallinn 13419, Estonia; Active, not recruiting

Pfizer Investigational Site, Tallinn 11312, Estonia; Active, not recruiting

Pfizer Investigational Site, Tartu 51007, Estonia; Active, not recruiting

Pfizer Investigational Site, Dijon 21000, France; Active, not recruiting

Pfizer Investigational Site, Amiens 80030, France; Completed

Pfizer Investigational Site, Hoyerswerda 02977, Germany; Active, not recruiting

Pfizer Investigational Site, Deggingen 73326, Germany; Completed

Pfizer Investigational Site, Muenchen 80639, Germany; Active, not recruiting

Pfizer Investigational Site, Berlin 12247, Germany; Active, not recruiting

Pfizer Investigational Site, Nuernberg 90402, Germany; Active, not recruiting

Pfizer Investigational Site, Hamburg 22415, Germany; Active, not recruiting

Pfizer Investigational Site, Kuenzing 94550, Germany; Active, not recruiting

Pfizer Investigational Site, Dresden 01129, Germany; Active, not recruiting

Pfizer Investigational Site, Berlin 13125, Germany; Active, not recruiting

Pfizer Investigational Site, Hamburg 22143, Germany; Active, not recruiting

Pfizer Investigational Site, Thessaloniki 54 636, Greece; Active, not recruiting

Pfizer Investigational Site, Guatemala 01010, Guatemala; Active, not recruiting

Pfizer Investigational Site, Ciudad de Guatemala, Guatemala; Active, not recruiting

Pfizer Investigational Site, Shatin, Hong Kong; Active, not recruiting

Pfizer Investigational Site, Lai Chi Kok, Hong Kong; Completed

Pfizer Investigational Site, Seoul 110-744, Korea, Republic of; Active, not recruiting

Pfizer Investigational Site, Seoul 138-736, Korea, Republic of; Active, not recruiting

Pfizer Investigational Site, Seoul 137-040, Korea, Republic of; Active, not recruiting

Pfizer Investigational Site, Seoul 135-710, Korea, Republic of; Completed

Pfizer Investigational Site, Seoul 133-792, Korea, Republic of; Active, not recruiting

Pfizer Investigational Site, Riga LV 1002, Latvia; Active, not recruiting

Pfizer Investigational Site, Riga LV 1006, Latvia; Active, not recruiting

Pfizer Investigational Site, Riga LV 1038, Latvia; Active, not recruiting

Pfizer Investigational Site, Vilnius LT-07156, Lithuania; Active, not recruiting

Pfizer Investigational Site, Kaunas LT-47144, Lithuania; Active, not recruiting

Pfizer Investigational Site, Klaipeda LT-94231, Lithuania; Active, not recruiting

Pfizer Investigational Site, Alytus LT-62114, Lithuania; Active, not recruiting

Pfizer Investigational Site, Kaunas LT-50425, Lithuania; Active, not recruiting

Pfizer Investigational Site, Alkmaar 1815 JD, Netherlands; Active, not recruiting

Pfizer Investigational Site, Leidschendam 2262 BA, Netherlands; Active, not recruiting

Pfizer Investigational Site, Ciudad de Panama, Panama; Recruiting

Pfizer Investigational Site, Lima 27, Peru; Active, not recruiting

Pfizer Investigational Site, Lima Lima 29, Peru; Active, not recruiting

Pfizer Investigational Site, Lima Lima 27, Peru; Active, not recruiting

Pfizer Investigational Site, Lima L11, Peru; Active, not recruiting

Pfizer Investigational Site, Ponta Delgada 9500-370, Portugal; Recruiting

Pfizer Investigational Site, Lisboa 1249-075, Portugal; Recruiting

Pfizer Investigational Site, Lisboa 1600-035, Portugal; Active, not recruiting

Pfizer Investigational Site, Ponte de Lima 4990-049, Portugal; Active, not recruiting

Pfizer Investigational Site, Ponte de Lima 4990-49, Portugal; Active, not recruiting

Pfizer Investigational Site, Lisbon 1000-247, Portugal; Active, not recruiting

Pfizer Investigational Site, Moscow 115522, Russian Federation; Active, not recruiting

Pfizer Investigational Site, Moscow 113093, Russian Federation; Active, not recruiting

Pfizer Investigational Site, Moscow 109004, Russian Federation; Active, not recruiting

Pfizer Investigational Site, Moscow 118089, Russian Federation; Active, not recruiting

Pfizer Investigational Site, St. Petersburg, Russian Federation; Active, not recruiting

Pfizer Investigational Site, Moscow 109240, Russian Federation; Active, not recruiting

Pfizer Investigational Site, Ekaterinburg 620043, Russian Federation; Active, not recruiting

Pfizer Investigational Site, St. Petersburg 190000, Russian Federation; Active, not recruiting

Pfizer Investigational Site, Moscow 109388, Russian Federation; Active, not recruiting

Pfizer Investigational Site, Petrozavodsk 185019, Russian Federation; Active, not recruiting

Pfizer Investigational Site, Smolensk 214019, Russian Federation; Active, not recruiting

Pfizer Investigational Site, NOVI SAD 21000, Serbia; Active, not recruiting

Pfizer Investigational Site, NISKA BANJA 18205, Serbia; Active, not recruiting

Pfizer Investigational Site, Niska Banja 18205, Serbia; Active, not recruiting

Pfizer Investigational Site, BELGRADE 11000, Serbia; Active, not recruiting

Pfizer Investigational Site, Belgrade 11000, Serbia; Active, not recruiting

Pfizer Investigational Site, Singapore 529889, Singapore; Active, not recruiting

Pfizer Investigational Site, Sinapore 308433, Singapore; Active, not recruiting

Pfizer Investigational Site, Singapore 119074, Singapore; Active, not recruiting

Pfizer Investigational Site, Bellville 7530, South Africa; Active, not recruiting

Pfizer Investigational Site, Cape Town, South Africa; Active, not recruiting

Pfizer Investigational Site, Observatory Cape Town 7925, South Africa; Active, not recruiting

Pfizer Investigational Site, Kempton Park, South Africa; Active, not recruiting

Pfizer Investigational Site, AVILA 05004, Spain; Active, not recruiting

Pfizer Investigational Site, BARCELONA 08036, Spain; Active, not recruiting

Pfizer Investigational Site, BARCELONA 08041, Spain; Active, not recruiting

Pfizer Investigational Site, MADRID 28046, Spain; Active, not recruiting

Pfizer Investigational Site, MADRID 28009, Spain; Active, not recruiting

Pfizer Investigational Site, ZARAGOZA 50009, Spain; Active, not recruiting

Pfizer Investigational Site, Goteborg 400 10, Sweden; Active, not recruiting

Pfizer Investigational Site, Goteborg 400 14, Sweden; Active, not recruiting

Pfizer Investigational Site, Lulea 972 33, Sweden; Active, not recruiting

Pfizer Investigational Site, NORRKOPING 602 32, Sweden; Active, not recruiting

Pfizer Investigational Site, Taichung 407, Taiwan; Completed

Pfizer Investigational Site, Tao-Yuan, Taiwan; Completed

Pfizer Investigational Site, Kaohsiung Hsien, Taiwan; Completed

Pfizer Investigational Site, Taipei 114, Taiwan; Completed

Pfizer Investigational Site, Tainan 407, Taiwan; Completed

Pfizer Investigational Site, Odessa 65025, Ukraine; Active, not recruiting

Pfizer Investigational Site, Kyiv 04050, Ukraine; Not yet recruiting

Pfizer Investigational Site, Simferopol 95017, Ukraine; Active, not recruiting

Pfizer Investigational Site, Odessa 65009, Ukraine; Active, not recruiting

Pfizer Investigational Site, Odessa 65026, Ukraine; Active, not recruiting

Pfizer Investigational Site, Lviv 79013, Ukraine; Completed

Pfizer Investigational Site, Kyiv 03151, Ukraine; Active, not recruiting

Pfizer Investigational Site, Donetsk 83114, Ukraine; Active, not recruiting

Pfizer Investigational Site, Zaporizhzhia 69118, Ukraine; Completed

Pfizer Investigational Site, Dnipropetrovsk 49008, Ukraine; Active, not recruiting

Pfizer Investigational Site, Kharkiv 61002, Ukraine; Active, not recruiting

Pfizer Investigational Site, Kharkiv 61178, Ukraine; Active, not recruiting

Pfizer Investigational Site, Donetsk 83003, Ukraine; Active, not recruiting

Pfizer Investigational Site, Kharkiv 61037, Ukraine; Active, not recruiting

Pfizer Investigational Site, Kharkiv 61018, Ukraine; Active, not recruiting

Pfizer Investigational Site, Kyiv 04053, Ukraine; Active, not recruiting

Pfizer Investigational Site, Ivano-Frankivsk 76018, Ukraine; Active, not recruiting

Pfizer Investigational Site, Lutsk 43024, Ukraine; Completed

Pfizer Investigational Site, Kiev 01103, Ukraine; Active, not recruiting

Pfizer Investigational Site, Chesterfield S40 4TF, United Kingdom; Active, not recruiting

Pfizer Investigational Site, Peterborough PE7 3JL, United Kingdom; Completed

Pfizer Investigational Site, Vale of Glamorgan CF62 7EB, United Kingdom; Completed

Pfizer Investigational Site, Bexhill on Sea TN39 5HE, United Kingdom; Completed

Pfizer Investigational Site, St Leonards on Sea TN37 6BG, United Kingdom; Completed

Pfizer Investigational Site, Swindon SN25 4YZ, United Kingdom; Active, not recruiting

Pfizer Investigational Site, Peterborough PE2 5GP, United Kingdom; Active, not recruiting

Pfizer Investigational Site, Wansford PE8 6PL, United Kingdom; Active, not recruiting

Pfizer Investigational Site, Canterbury CT1 3HX, United Kingdom; Active, not recruiting

Pfizer Investigational Site, Glasgow G42 7AF, United Kingdom; Active, not recruiting

Pfizer Investigational Site, PARTIDA DE BACAROT, ALICANTE 03114, Spain; Active, not recruiting

Pfizer Investigational Site, OVIEDO, ASTURIAS 33006, Spain; Active, not recruiting

Pfizer Investigational Site, Hyderabad, Andhra Pradesh 500 033, India; Active, not recruiting

Pfizer Investigational Site, Medellin, Antioquia, Colombia; Active, not recruiting

Pfizer Investigational Site, Helensburgh, Argyle & Clyde G84 7QL, United Kingdom; Active, not recruiting

Pfizer Investigational Site, Barranquilla, Atlantico, Colombia; Active, not recruiting

Pfizer Investigational Site, Barranquilla, Atlantico, Colombia; Active, not recruiting

Pfizer Investigational Site, Cuenca, Azogues, Ecuador; Completed

Pfizer Investigational Site, SABADELL, BARCELONA 08208, Spain; Active, not recruiting

Pfizer Investigational Site, Maidenhead, BERKS SL6 6EL, United Kingdom; Active, not recruiting

Pfizer Investigational Site, Plzen, Bory 30599, Czech Republic; Active, not recruiting

Pfizer Investigational Site, Aston Clinton, Buckinghamshire HP22 5LB, United Kingdom; Active, not recruiting

Pfizer Investigational Site, St Austell, Cornwall PL26 7RL, United Kingdom; Active, not recruiting

Pfizer Investigational Site, Bogota, Cundinamarca, Colombia; Active, not recruiting

Pfizer Investigational Site, Bexhill on Sea, East Sussex TN39 4SP, United Kingdom; Completed

Pfizer Investigational Site, Bloemfontein, Free State 9310, South Africa; Active, not recruiting

Pfizer Investigational Site, Goiânia, GO 74043-110, Brazil; Active, not recruiting

Pfizer Investigational Site, Goiânia, GO 74110-120, Brazil; Active, not recruiting

Pfizer Investigational Site, Johannesburg, Gauteng 2193, South Africa; Not yet recruiting

Pfizer Investigational Site, Johannesburg, Gauteng Province 2193, South Africa; Active, not recruiting

Pfizer Investigational Site, Guangzhou, Guangdong 510630, China; Active, not recruiting

Pfizer Investigational Site, Guayaquil, Guayas, Ecuador; Completed

Pfizer Investigational Site, Odiham, Hampshire RG29 1JY, United Kingdom; Active, not recruiting

Pfizer Investigational Site, Basingstoke, Hampshire RG22 4EH, United Kingdom; Active, not recruiting

Pfizer Investigational Site, Aldershot, Hampshire GU12 5BA, United Kingdom; Active, not recruiting

Pfizer Investigational Site, Nanjing, Jiangsu 210008, China; Active, not recruiting

Pfizer Investigational Site, Durban, KZN 4091, South Africa; Active, not recruiting

Pfizer Investigational Site, Bangalore, Karnataka 560054, India; Active, not recruiting

Pfizer Investigational Site, Bangalore, Karnataka 560 034, India; Active, not recruiting

Pfizer Investigational Site, Bangalore, Karnataka 560 003, India; Active, not recruiting

Pfizer Investigational Site, Surco, Lima Lima 33, Peru; Active, not recruiting

Pfizer Investigational Site, HARROW, MIDDLESEX HA3 7LT, United Kingdom; Active, not recruiting

Pfizer Investigational Site, Winnipeg, Manitoba R3A 1M3, Canada; Active, not recruiting

Pfizer Investigational Site, Ashford, Middlesex TW15 3EA, United Kingdom; Active, not recruiting

Pfizer Investigational Site, St. John's, Newfoundland and Labrador A1B 3E1, Canada; Completed

Pfizer Investigational Site, Newmarket, Ontario L3Y 3R7, Canada; Active, not recruiting

Pfizer Investigational Site, Windsor, Ontario N8X 5A6, Canada; Active, not recruiting

Pfizer Investigational Site, Hamilton, Ontario L8N 1Y2, Canada; Completed

Pfizer Investigational Site, Curitiba, PR 80060-240, Brazil; Active, not recruiting

Pfizer Investigational Site, Curitiba, PR 80060-900, Brazil; Active, not recruiting

Pfizer Investigational Site, Quito, Pichincha, Ecuador; Completed

Pfizer Investigational Site, Ludhiana, Punjab 141 001, India; Active, not recruiting

Pfizer Investigational Site, Ste Foy, Quebec G1V 3M7, Canada; Active, not recruiting

Pfizer Investigational Site, Sherbrooke, Quebec J1H 5N4, Canada; Active, not recruiting

Pfizer Investigational Site, Pointe Claire, Quebec H9R 3J1, Canada; Completed

Pfizer Investigational Site, Rio de Janeiro, RJ 22271-100, Brazil; Active, not recruiting

Pfizer Investigational Site, Porto Alegre, RS 90035-903, Brazil; Active, not recruiting

Pfizer Investigational Site, Sao Paulo, SP 04230-000, Brazil; Active, not recruiting

Pfizer Investigational Site, São Paulo, SP 05403-010, Brazil; Active, not recruiting

Pfizer Investigational Site, São Paulo, SP 05437-010, Brazil; Active, not recruiting

Pfizer Investigational Site, East Horsley, Leatherhead, SURREY KT24 6QT, United Kingdom; Active, not recruiting

Pfizer Investigational Site, Floridablanca, Santander, Colombia; Active, not recruiting

Pfizer Investigational Site, Chengdu, Sichuan 610041, China; Active, not recruiting

Pfizer Investigational Site, Camberley, Surrey GU15 2NN, United Kingdom; Completed

Pfizer Investigational Site, Ostrava, Trebovice 722 00, Czech Republic; Completed

Pfizer Investigational Site, BARAKALDO, VIZCAYA 48903, Spain; Active, not recruiting

Pfizer Investigational Site, Pound Hill, Crawley, WEST SUSSEX RH10 7DX, United Kingdom; Active, not recruiting

Pfizer Investigational Site, Upton, WIRRAL L49 5PE, United Kingdom; Active, not recruiting

Pfizer Investigational Site, Parow, Western Cape 7500, South Africa; Active, not recruiting

Pfizer Investigational Site, Bradford-on-Avon, Wiltshire BA1 5DQ, United Kingdom; Active, not recruiting

Pfizer Investigational Site, Chippenham, Wiltshire SN14 6GT, United Kingdom; Active, not recruiting

Pfizer Investigational Site, Vlaardingen, ZH 3136 LA, Netherlands; Active, not recruiting

To obtain contact information for a study center near you, click here.

Starting date: October 2005
Ending date: May 2009
Last updated: January 29, 2009