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

NCT00141102 | Completed Phase 4 Results DMC

• 1 other identifier: A3191084
• Study Type: interventional
• Target: 4,484
• Locations: 29 countries
• Sites: 182

Brief Summary

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.

Conditions

Osteoarthritis; Arthritis, Rheumatoid

Keywords

GI events in high risk GI arthritis patients

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs)

  CSULGIE=any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; clinically significant anemia of defined GI origin; acute GI hemorrhage of unknown origin, including presumed small bowel hemorrhage; clinically significant anemia of presumed occult GI origin including possible small bowel blood loss. Subjects were assessed by an independent GI Events Adjudication Committee, who were blinded to study treatment assignments.

  6 month treatment duration

Secondary Outcomes (14)

• Number of Subjects With CSULGIES or Symptomatic Ulcers (SUs)

  6 month treatment duration

• Change From Baseline in Patient's Global Arthritis Assessment at Month 6/Early Termination (ET)

  Month 6/Early Termination (ET)

• Number of Subjects With SUs

  6 month treatment duration

• Number of Subjects With CSULGIEs by History of GD Ulceration

  6 month treatment duration

• Number of Subjects With Moderate to Severe Abdominal Symptoms

  6 month treatment duration

Other Outcomes (2)

• Number of Subjects Alive at the Post Trial Interview

  6 months following last dose

• Number of Subjects Hospitalized in Last 6 Months at the Post Trial Interview

  6 months following last dose

Study Arms (2)

A

EXPERIMENTAL

Drug: Celecoxib

B

ACTIVE COMPARATOR

Drug: Diclofenac + Omeprazole

Interventions

Celecoxib DRUG

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

A

Diclofenac + Omeprazole DRUG

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

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (194)

Pfizer Investigational Site

Genk, 3600, Belgium

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Ghent, 9000, Belgium

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Hasselt, 3500, Belgium

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Liège, 4000, Belgium

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Goiânia, Goiás, 74043-110, Brazil

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Goiânia, Goiás, 74110-120, Brazil

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Curitiba, Paraná, 80060-240, Brazil

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Curitiba, Paraná, 80060-900, Brazil

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Rio de Janeiro, Rio de Janeiro, 22271-100, Brazil

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Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

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São Paulo, São Paulo, 04230-000, Brazil

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São Paulo, São Paulo, 05403-010, Brazil

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São Paulo, São Paulo, 05437-010, Brazil

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Winnipeg, Manitoba, R3A 1M3, Canada

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

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Hamilton, Ontario, L8N 1Y2, Canada

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Newmarket, Ontario, L3Y 3R7, Canada

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Windsor, Ontario, N8X 5A6, Canada

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Pointe-Claire, Quebec, H9R 3J1, Canada

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Sherbrooke, Quebec, J1H 5N4, Canada

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Ste Foy, Quebec, G1V 3M7, Canada

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Guangzhou, Guangdong, 510630, China

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Nanjing, Jiangsu, 210008, China

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Chengdu, Sichuan, 610041, China

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Beijing, 100020, China

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Beijing, 100044, China

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Beijing, 100073, China

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Beijing, 100853, China

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Shanghai, 200001, China

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Shanghai, 200040, China

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Tianjin, 300052, China

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Tianjin, 300192, China

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Medellín, Antioquia, 0, Colombia

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Barranquilla, Atlántico, 0, Colombia

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Barranquilla, Atlántico, Colombia

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Bogota, Cundinamarca, 0, Colombia

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Floridablanca, Santander Department, 0, Colombia

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Cartago, Costa Rica

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Heredia, Costa Rica

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San José, 3er piso., Costa Rica

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San José, Costa Rica

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Opatija, 51410, Croatia

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Zagreb, 10000, Croatia

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Pilsen, Bory, 30599, Czechia

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Ostrava, Trebovice, 722 00, Czechia

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České Budějovice, 370 01, Czechia

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Hradec Králové, 50012, Czechia

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Prague, 118 00, Czechia

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Prague, 120 00, Czechia

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Prague, 128 50, Czechia

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Prague, 140 59, Czechia

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Prague, 16900, 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, 11312, Estonia

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Tallinn, 13419, Estonia

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Tartu, 51007, Estonia

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Amiens, 80030, France

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Dijon, 21000, France

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Berlin, 12247, Germany

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Berlin, 13125, Germany

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Deggingen, 73326, Germany

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Dresden, 01129, Germany

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Hamburg, 22143, Germany

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Hamburg, 22415, Germany

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Hoyerswerda, 02977, Germany

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Künzing, 94550, Germany

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München, 80639, Germany

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Nuremberg, 90402, Germany

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Thessaloniki, 54 636, 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, 500 033, India

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Bangalore, Karnataka, 560 034, India

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Bangalore, Karnataka, 560 079, India

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Bangalore, Karnataka, 560054, India

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Ludhiana, Punjab, 141 001, India

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Riga, LV 1002, Latvia

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Riga, LV 1006, Latvia

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Riga, LV 1038, Latvia

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Alytus, LT-62114, Lithuania

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Kaunas, LT-47144, Lithuania

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Kaunas, LT-50425, Lithuania

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Klaipėda, LT-94231, Lithuania

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Vilnius, LT-07156, Lithuania

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Vlaardingen, South Holland, 3136 LA, Netherlands

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Alkmaar, 1815 JD, Netherlands

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Leidschendam, 2262 BA, Netherlands

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Panama City, Panama

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Surco, Lima region, Lima 33, Peru

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Lima, 27, Peru

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Lima, L11, Peru

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Lima, Lima 27, Peru

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Lima, Lima 29, Peru

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Lisbon, 1000-247, Portugal

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Lisbon, 1249-075, Portugal

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Lisbon, 1600-035, Portugal

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Ponta Delgada, 9500-370, Portugal

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Ponte de Lima, 4990-049, Portugal

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Ponte de Lima, 4990-49, Portugal

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Moscow, 109004, Russia

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Moscow, 109240, Russia

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Moscow, 109388, Russia

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Moscow, 113093, Russia

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Moscow, 115522, Russia

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Moscow, 118089, Russia

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Petrozavodsk, 185019, Russia

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Saint Petersburg, 190000, Russia

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Saint Petersburg, Russia

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Smolensk, 214019, Russia

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Yekaterinburg, 620043, Russia

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Belgrade, 11000, Serbia

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Niška Banja, 18205, Serbia

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Novi Sad, 21000, Serbia

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Sinapore, 308433, Singapore

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Singapore, 119074, Singapore

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Singapore, 529889, Singapore

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Bloemfontein, Free State, 9310, South Africa

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Johannesburg, Gauteng, 2193, South Africa

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Durban, KwaZulu-Natal, 4091, South Africa

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Parow, Western Cape, 7500, South Africa

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Bellville, 7530, 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, 7925, South Africa

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Seoul, 110-744, South Korea

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Seoul, 133-792, South Korea

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Seoul, 135-710, South Korea

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Seoul, 137-040, South Korea

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Seoul, 138-736, South Korea

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Partida de Bacarot, Alicante, 03114, Spain

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Sabadell, Barcelona, 08208, Spain

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Oviedo, Principality of Asturias, 33006, Spain

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Barakaldo, Vizcaya, 48903, Spain

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Ávila, 05004, Spain

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Barcelona, 08036, Spain

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Barcelona, 08041, Spain

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Madrid, 28009, Spain

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Madrid, 28046, Spain

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Zaragoza, 50009, Spain

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Gothenburg, 400 10, Sweden

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Gothenburg, 400 14, Sweden

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Luleå, 972 33, Sweden

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Norrköping, 602 32, Sweden

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Kaohsiung Hsien, Taiwan

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Taichung, 407, Taiwan

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Tainan, 407, Taiwan

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Taipei, 114, Taiwan

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Taoyuan District, Taiwan

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Dnipropetrovsk, 49008, Ukraine

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Donetsk, 83003, Ukraine

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Donetsk, 83114, Ukraine

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Ivano-Frankivsk, 76018, Ukraine

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Kharkiv, 61002, Ukraine

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Kharkiv, 61018, Ukraine

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Kharkiv, 61037, Ukraine

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Kharkiv, 61178, Ukraine

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Kiev, 01103, Ukraine

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Kyiv, 04053, Ukraine

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Lutsk, 43024, Ukraine

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Lviv, 79013, Ukraine

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Odesa, 65009, Ukraine

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Odesa, 65025, Ukraine

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Odesa, 65026, Ukraine

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Simferopol, 95017, Ukraine

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Zaporizhzhia, 69118, Ukraine

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Helensburgh, Argyle & Clyde, G84 7QL, United Kingdom

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Maidenhead, Berks, SL6 6EL, United Kingdom

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Aston Clinton, Buckinghamshire, HP22 5LB, United Kingdom

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St Austell, Cornwall, PL26 7RL, United Kingdom

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Bexhill-on-Sea, East Sussex, TN39 4SP, United Kingdom

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Aldershot, Hampshire, GU12 5BA, United Kingdom

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Basingstoke, Hampshire, RG22 4EH, United Kingdom

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Odiham, Hampshire, RG29 1JY, United Kingdom

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Ashford, Middlesex, TW15 3EA, United Kingdom

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Harrow, Middlesex, HA3 7LT, United Kingdom

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Camberley, Surrey, GU15 2NN, United Kingdom

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East Horsley, Leatherhead, Surrey, KT24 6QT, United Kingdom

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Pound Hill, Crawley, WEST Sussex, RH10 7DX, United Kingdom

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Bradford-on-Avon, Wiltshire, BA1 5DQ, United Kingdom

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Chippenham, Wiltshire, SN14 6GT, United Kingdom

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Upton, Wirral, L49 5PE, United Kingdom

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Bexhill-on-Sea, TN39 5HE, United Kingdom

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Canterbury, CT1 3HX, United Kingdom

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Chesterfield, S40 4TF, United Kingdom

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Glasgow, G42 7AF, United Kingdom

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Peterborough, PE2 5GP, United Kingdom

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Peterborough, PE7 3JL, United Kingdom

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Saint Leonards-on-Sea, TN37 6BG, United Kingdom

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Swindon, SN25 4YZ, United Kingdom

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Vale of Glamorgan, CF62 7EB, United Kingdom

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Wansford, PE8 6PL, United Kingdom

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Related Publications (2)

• 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.

  PMID: 24358067 DERIVED

• 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.

  PMID: 20638563 DERIVED

Related Links

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

MeSH Terms

Conditions

Osteoarthritis; Arthritis, Rheumatoid

Interventions

Celecoxib; Diclofenac; Omeprazole

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2005
• First Posted: September 1, 2005
• Study Start: October 1, 2005
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: March 3, 2021
• Results First Posted: June 11, 2010

Record last verified: 2021-03

Locations

CZ (9); ES (10); GR (1); TW (5); PA (1); BR (9); SE (3); EC (3); RU (11); BE (4); KR (5); NL (3); ZA (8); DE (10); CN (11); IN (5); PT (6); CA (8); PE (5); LA (3); UA (17); CR (2); GB (26); CO (4); SG (3); LI (5); FR (2); HK (2); GU (1)