Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis
NCT ID: NCT00141102
Last Updated: 2021-03-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
4484 participants
INTERVENTIONAL
2005-10-31
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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A
Celecoxib
Participants are assigned to one of two groups in parallel for the duration of the study
B
Diclofenac + Omeprazole
Participants are assigned to one of two groups in parallel for the duration of the study
Interventions
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Celecoxib
Participants are assigned to one of two groups in parallel for the duration of the study
Diclofenac + Omeprazole
Participants are assigned to one of two groups in parallel for the duration of the study
Eligibility Criteria
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Inclusion Criteria
* 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
* Concomitant use of low dose aspirin
* Previous MI, stroke or significant vascular disease.
18 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Genk, , Belgium
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Ghent, , Belgium
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Hasselt, , Belgium
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Liège, , Belgium
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Goiânia, Goiás, Brazil
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Goiânia, Goiás, Brazil
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Curitiba, Paraná, Brazil
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Curitiba, Paraná, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Winnipeg, Manitoba, Canada
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St. John's, Newfoundland and Labrador, Canada
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Hamilton, Ontario, Canada
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Newmarket, Ontario, Canada
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Windsor, Ontario, Canada
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Pointe-Claire, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Ste Foy, Quebec, Canada
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Guangzhou, Guangdong, China
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Nanjing, Jiangsu, China
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Chengdu, Sichuan, China
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Beijing, , China
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Beijing, , China
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Beijing, , China
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Beijing, , China
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Shanghai, , China
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Shanghai, , China
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Tianjin, , China
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Tianjin, , China
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Medellín, Antioquia, Colombia
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Barranquilla, Atlántico, Colombia
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Barranquilla, Atlántico, Colombia
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Bogota, Cundinamarca, Colombia
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Floridablanca, Santander Department, Colombia
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Cartago, , Costa Rica
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Heredia, , Costa Rica
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San José, , Costa Rica
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San José, , Costa Rica
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Opatija, , Croatia
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Zagreb, , Croatia
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Pilsen, Bory, Czechia
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Ostrava, Trebovice, Czechia
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České Budějovice, , Czechia
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Hradec Králové, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Cuenca, Azuay, Ecuador
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Guayaquil, Guayas, Ecuador
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Quito, Pichincha, Ecuador
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Tallinn, , Estonia
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Tallinn, , Estonia
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Tartu, , Estonia
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Amiens, , France
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Dijon, , France
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Berlin, , Germany
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Berlin, , Germany
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Deggingen, , Germany
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Dresden, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hoyerswerda, , Germany
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Künzing, , Germany
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München, , Germany
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Nuremberg, , Germany
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Thessaloniki, , Greece
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Guatemala City, , Guatemala
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Lai Chi Kok, , Hong Kong
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Shatin, , Hong Kong
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Hyderabad, Andhra Pradesh, India
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Bangalore, Karnataka, India
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Bangalore, Karnataka, India
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Bangalore, Karnataka, India
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Ludhiana, Punjab, India
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Riga, , Latvia
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Riga, , Latvia
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Riga, , Latvia
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Alytus, , Lithuania
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Kaunas, , Lithuania
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Kaunas, , Lithuania
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Klaipėda, , Lithuania
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Vilnius, , Lithuania
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Vlaardingen, South Holland, Netherlands
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Alkmaar, , Netherlands
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Leidschendam, , Netherlands
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Panama City, , Panama
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Surco, Lima region, Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Lisbon, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Ponta Delgada, , Portugal
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Ponte de Lima, , Portugal
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Ponte de Lima, , Portugal
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Petrozavodsk, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Smolensk, , Russia
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Yekaterinburg, , Russia
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Belgrade, , Serbia
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Niška Banja, , Serbia
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Novi Sad, , Serbia
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Sinapore, , Singapore
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Singapore, , Singapore
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Singapore, , Singapore
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Bloemfontein, Free State, South Africa
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Johannesburg, Gauteng, South Africa
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Durban, KwaZulu-Natal, South Africa
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Parow, Western Cape, South Africa
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Bellville, , South Africa
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Cape Town, , South Africa
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Kempton Park, , South Africa
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Observatory Cape Town, , South Africa
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Partida de Bacarot, Alicante, Spain
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Sabadell, Barcelona, Spain
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Oviedo, Principality of Asturias, Spain
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Barakaldo, Vizcaya, Spain
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Ávila, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Zaragoza, , Spain
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Gothenburg, , Sweden
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Gothenburg, , Sweden
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Luleå, , Sweden
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Norrköping, , Sweden
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Kaohsiung Hsien, , Taiwan
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Taichung, , Taiwan
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Tainan City, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Dnipropetrovsk, , Ukraine
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Donetsk, , Ukraine
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Donetsk, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kharkiv, , Ukraine
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Kharkiv, , Ukraine
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Kharkiv, , Ukraine
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Kharkiv, , Ukraine
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Kiev, , Ukraine
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Kyiv, , Ukraine
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Lutsk, , Ukraine
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Lviv, , Ukraine
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Odesa, , Ukraine
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Odesa, , Ukraine
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Odesa, , Ukraine
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Simferopol, , Ukraine
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Zaporizhzhia, , Ukraine
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Helensburgh, Argyle & Clyde, United Kingdom
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Maidenhead, Berks, United Kingdom
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Aston Clinton, Buckinghamshire, United Kingdom
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St Austell, Cornwall, United Kingdom
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Bexhill-on-Sea, East Sussex, United Kingdom
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Aldershot, Hampshire, United Kingdom
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Basingstoke, Hampshire, United Kingdom
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Odiham, Hampshire, United Kingdom
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Ashford, Middlesex, United Kingdom
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Harrow, Middlesex, United Kingdom
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Camberley, Surrey, United Kingdom
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East Horsley, Leatherhead, Surrey, United Kingdom
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Pound Hill, Crawley, WEST Sussex, United Kingdom
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Bradford-on-Avon, Wiltshire, United Kingdom
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Chippenham, Wiltshire, United Kingdom
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Upton, Wirral, United Kingdom
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Bexhill-on-Sea, , United Kingdom
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Canterbury, , United Kingdom
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Chesterfield, , United Kingdom
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Glasgow, , United Kingdom
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Peterborough, , United Kingdom
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Peterborough, , United Kingdom
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Saint Leonards-on-Sea, , United Kingdom
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Swindon, , United Kingdom
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Vale of Glamorgan, , United Kingdom
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Wansford, , United Kingdom
Countries
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References
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Kellner HL, Li C, Essex MN. Celecoxib and Diclofenac Plus Omeprazole are Similarly Effective in the Treatment of Arthritis in Patients at High GI Risk in the CONDOR Trial. Open Rheumatol J. 2013 Nov 13;7:96-100. doi: 10.2174/1874312901307010096. eCollection 2013.
Chan FK, Lanas A, Scheiman J, Berger MF, Nguyen H, Goldstein JL. Celecoxib versus omeprazole and diclofenac in patients with osteoarthritis and rheumatoid arthritis (CONDOR): a randomised trial. Lancet. 2010 Jul 17;376(9736):173-9. doi: 10.1016/S0140-6736(10)60673-3. Epub 2010 Jun 16.
Related Links
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Other Identifiers
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A3191084
Identifier Type: -
Identifier Source: org_study_id
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