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

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

4484 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2009-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis Arthritis, Rheumatoid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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A

Group Type EXPERIMENTAL

Celecoxib

Intervention Type DRUG

Participants are assigned to one of two groups in parallel for the duration of the study

B

Group Type ACTIVE_COMPARATOR

Diclofenac + Omeprazole

Intervention Type DRUG

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

Intervention Type DRUG

Diclofenac + Omeprazole

Participants are assigned to one of two groups in parallel for the duration of the study

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

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Countries

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Belgium Brazil Canada China Colombia Costa Rica Croatia Czechia Ecuador Estonia France Germany Greece Guatemala Hong Kong India Latvia Lithuania Netherlands Panama Peru Portugal Russia Serbia Singapore South Africa South Korea Spain Sweden Taiwan Ukraine United Kingdom

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.

Reference Type DERIVED
PMID: 24358067 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20638563 (View on PubMed)

Related Links

Other Identifiers

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A3191084

Identifier Type: -

Identifier Source: org_study_id

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