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

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

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.

Study Overview

• Status: Completed
• Conditions: Arthritis, Rheumatoid; Osteoarthritis
• Intervention / Treatment: Drug: Celecoxib; Drug: Diclofenac + Omeprazole

• Study Type: Interventional
• Enrollment (Actual): 4484
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Genk, Belgium, 3600
    • Pfizer Investigational Site
  • Gent, Belgium, 9000
    • Pfizer Investigational Site
  • Hasselt, Belgium, 3500
    • Pfizer Investigational Site
  • Liège, Belgium, 4000
    • Pfizer Investigational Site
• Brazil
  • GO
    • Goiânia, GO, Brazil, 74043-110
      • Pfizer Investigational Site
    • Goiânia, GO, Brazil, 74110-120
      • Pfizer Investigational Site
  • PR
    • Curitiba, PR, Brazil, 80060-900
      • Pfizer Investigational Site
    • Curitiba, PR, Brazil, 80060-240
      • Pfizer Investigational Site
  • RJ
    • Rio de Janeiro, RJ, Brazil, 22271-100
      • Pfizer Investigational Site
  • RS
    • Porto Alegre, RS, Brazil, 90035-903
      • Pfizer Investigational Site
  • SP
    • Sao Paulo, SP, Brazil, 04230-000
      • Pfizer Investigational Site
    • São Paulo, SP, Brazil, 05403-010
      • Pfizer Investigational Site
    • São Paulo, SP, Brazil, 05437-010
      • Pfizer Investigational Site
• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1M3
      • Pfizer Investigational Site
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1B 3E1
      • Pfizer Investigational Site
  • Ontario
    • Hamilton, Ontario, Canada, L8N 1Y2
      • Pfizer Investigational Site
    • Newmarket, Ontario, Canada, L3Y 3R7
      • Pfizer Investigational Site
    • Windsor, Ontario, Canada, N8X 5A6
      • Pfizer Investigational Site
  • Quebec
    • Pointe Claire, Quebec, Canada, H9R 3J1
      • Pfizer Investigational Site
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Pfizer Investigational Site
    • Ste Foy, Quebec, Canada, G1V 3M7
      • Pfizer Investigational Site
• China
  • Beijing, China, 100853
    • Pfizer Investigational Site
  • Beijing, China, 100020
    • Pfizer Investigational Site
  • Beijing, China, 100044
    • Pfizer Investigational Site
  • Beijing, China, 100073
    • Pfizer Investigational Site
  • Shanghai, China, 200001
    • Pfizer Investigational Site
  • Shanghai, China, 200040
    • Pfizer Investigational Site
  • Tianjin, China, 300052
    • Pfizer Investigational Site
  • Tianjin, China, 300192
    • Pfizer Investigational Site
  • Guangdong
    • Guangzhou, Guangdong, China, 510630
      • Pfizer Investigational Site
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Pfizer Investigational Site
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Pfizer Investigational Site
• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia
      • Pfizer Investigational Site
  • Atlantico
    • Barranquilla, Atlantico, Colombia
      • Pfizer Investigational Site
    • Barranquilla, Atlantico, Colombia
      • Pfizer Investigational Site
  • Cundinamarca
    • Bogota, Cundinamarca, Colombia
      • Pfizer Investigational Site
  • Santander
    • Floridablanca, Santander, Colombia
      • Pfizer Investigational Site
• Costa Rica
  • Cartago, Costa Rica
    • Pfizer Investigational Site
  • Heredia, Costa Rica
    • Pfizer Investigational Site
  • San Jose, Costa Rica
    • Pfizer Investigational Site
  • San Jose, Costa Rica, 3er piso.
    • Pfizer Investigational Site
• Croatia
  • Opatija, Croatia, 51410
    • Pfizer Investigational Site
  • Zagreb, Croatia, 10000
    • Pfizer Investigational Site
• Czechia
  • Ceske Budejovice, Czechia, 370 01
    • Pfizer Investigational Site
  • Hradec Kralove, Czechia, 50012
    • Pfizer Investigational Site
  • Prague 1, Czechia, 118 00
    • Pfizer Investigational Site
  • Praha 2, Czechia, 120 00
    • Pfizer Investigational Site
  • Praha 2, Czechia, 128 50
    • Pfizer Investigational Site
  • Praha 4, Czechia, 140 59
    • Pfizer Investigational Site
  • Praha 6, Czechia, 16900
    • Pfizer Investigational Site
  • Bory
    • Plzen, Bory, Czechia, 30599
      • Pfizer Investigational Site
  • Trebovice
    • Ostrava, Trebovice, Czechia, 722 00
      • Pfizer Investigational Site
• Ecuador
  • Azuay
    • Cuenca, Azuay, Ecuador
      • Pfizer Investigational Site
  • Guayas
    • Guayaquil, Guayas, Ecuador
      • Pfizer Investigational Site
  • Pichincha
    • Quito, Pichincha, Ecuador
      • Pfizer Investigational Site
• Estonia
  • Tallinn, Estonia, 13419
    • Pfizer Investigational Site
  • Tallinn, Estonia, 11312
    • Pfizer Investigational Site
  • Tartu, Estonia, 51007
    • Pfizer Investigational Site
• France
  • Amiens, France, 80030
    • Pfizer Investigational Site
  • Dijon, France, 21000
    • Pfizer Investigational Site
• Germany
  • Berlin, Germany, 13125
    • Pfizer Investigational Site
  • Berlin, Germany, 12247
    • Pfizer Investigational Site
  • Deggingen, Germany, 73326
    • Pfizer Investigational Site
  • Dresden, Germany, 01129
    • Pfizer Investigational Site
  • Hamburg, Germany, 22143
    • Pfizer Investigational Site
  • Hamburg, Germany, 22415
    • Pfizer Investigational Site
  • Hoyerswerda, Germany, 02977
    • Pfizer Investigational Site
  • Kuenzing, Germany, 94550
    • Pfizer Investigational Site
  • Muenchen, Germany, 80639
    • Pfizer Investigational Site
  • Nuernberg, Germany, 90402
    • Pfizer Investigational Site
• Greece
  • Thessaloniki, Greece, 54 636
    • Pfizer Investigational Site
• Guatemala
  • Ciudad de Guatemala, Guatemala
    • Pfizer Investigational Site
  • Guatemala 01010, Guatemala
    • Pfizer Investigational Site
• Hong Kong
  • Lai Chi Kok, Hong Kong
    • Pfizer Investigational Site
  • Shatin, Hong Kong
    • Pfizer Investigational Site
• India
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500 033
      • Pfizer Investigational Site
  • Karnataka
    • Bangalore, Karnataka, India, 560 034
      • Pfizer Investigational Site
    • Bangalore, Karnataka, India, 560054
      • Pfizer Investigational Site
    • Bangalore, Karnataka, India, 560 079
      • Pfizer Investigational Site
  • Punjab
    • Ludhiana, Punjab, India, 141 001
      • Pfizer Investigational Site
• Korea, Republic of
  • Seoul, Korea, Republic of, 138-736
    • Pfizer Investigational Site
  • Seoul, Korea, Republic of, 110-744
    • Pfizer Investigational Site
  • Seoul, Korea, Republic of, 135-710
    • Pfizer Investigational Site
  • Seoul, Korea, Republic of, 133-792
    • Pfizer Investigational Site
  • Seoul, Korea, Republic of, 137-040
    • Pfizer Investigational Site
• Latvia
  • Riga, Latvia, LV 1002
    • Pfizer Investigational Site
  • Riga, Latvia, LV 1006
    • Pfizer Investigational Site
  • Riga, Latvia, LV 1038
    • Pfizer Investigational Site
• Lithuania
  • Alytus, Lithuania, LT-62114
    • Pfizer Investigational Site
  • Kaunas, Lithuania, LT-47144
    • Pfizer Investigational Site
  • Kaunas, Lithuania, LT-50425
    • Pfizer Investigational Site
  • Klaipeda, Lithuania, LT-94231
    • Pfizer Investigational Site
  • Vilnius, Lithuania, LT-07156
    • Pfizer Investigational Site
• Netherlands
  • Alkmaar, Netherlands, 1815 JD
    • Pfizer Investigational Site
  • Leidschendam, Netherlands, 2262 BA
    • Pfizer Investigational Site
  • ZH
    • Vlaardingen, ZH, Netherlands, 3136 LA
      • Pfizer Investigational Site
• Panama
  • Ciudad de Panama, Panama
    • Pfizer Investigational Site
• Peru
  • Lima, Peru, L11
    • Pfizer Investigational Site
  • Lima, Peru, 27
    • Pfizer Investigational Site
  • Lima, Peru, Lima 27
    • Pfizer Investigational Site
  • Lima, Peru, Lima 29
    • Pfizer Investigational Site
  • Lima
    • Surco, Lima, Peru, Lima 33
      • Pfizer Investigational Site
• Portugal
  • Lisboa, Portugal, 1249-075
    • Pfizer Investigational Site
  • Lisboa, Portugal, 1600-035
    • Pfizer Investigational Site
  • Lisbon, Portugal, 1000-247
    • Pfizer Investigational Site
  • Ponta Delgada, Portugal, 9500-370
    • Pfizer Investigational Site
  • Ponte de Lima, Portugal, 4990-049
    • Pfizer Investigational Site
  • Ponte de Lima, Portugal, 4990-49
    • Pfizer Investigational Site
• Russian Federation
  • Ekaterinburg, Russian Federation, 620043
    • Pfizer Investigational Site
  • Moscow, Russian Federation, 115522
    • Pfizer Investigational Site
  • Moscow, Russian Federation, 109388
    • Pfizer Investigational Site
  • Moscow, Russian Federation, 113093
    • Pfizer Investigational Site
  • Moscow, Russian Federation, 109004
    • Pfizer Investigational Site
  • Moscow, Russian Federation, 109240
    • Pfizer Investigational Site
  • Moscow, Russian Federation, 118089
    • Pfizer Investigational Site
  • Petrozavodsk, Russian Federation, 185019
    • Pfizer Investigational Site
  • Smolensk, Russian Federation, 214019
    • Pfizer Investigational Site
  • St. Petersburg, Russian Federation
    • Pfizer Investigational Site
  • St. Petersburg, Russian Federation, 190000
    • Pfizer Investigational Site
• Serbia
  • Belgrade, Serbia, 11000
    • Pfizer Investigational Site
  • Niska Banja, Serbia, 18205
    • Pfizer Investigational Site
  • Novi Sad, Serbia, 21000
    • Pfizer Investigational Site
• Singapore
  • Sinapore, Singapore, 308433
    • Pfizer Investigational Site
  • Singapore, Singapore, 119074
    • Pfizer Investigational Site
  • Singapore, Singapore, 529889
    • Pfizer Investigational Site
• South Africa
  • Bellville, South Africa, 7530
    • Pfizer Investigational Site
  • Cape Town, South Africa
    • Pfizer Investigational Site
  • Kempton Park, South Africa
    • Pfizer Investigational Site
  • Observatory Cape Town, South Africa, 7925
    • Pfizer Investigational Site
  • Free State
    • Bloemfontein, Free State, South Africa, 9310
      • Pfizer Investigational Site
  • Gauteng Province
    • Johannesburg, Gauteng Province, South Africa, 2193
      • Pfizer Investigational Site
  • KZN
    • Durban, KZN, South Africa, 4091
      • Pfizer Investigational Site
  • Western Cape
    • Parow, Western Cape, South Africa, 7500
      • Pfizer Investigational Site
• Spain
  • Avila, Spain, 05004
    • Pfizer Investigational Site
  • Barcelona, Spain, 08036
    • Pfizer Investigational Site
  • Barcelona, Spain, 08041
    • Pfizer Investigational Site
  • Madrid, Spain, 28046
    • Pfizer Investigational Site
  • Madrid, Spain, 28009
    • Pfizer Investigational Site
  • Zaragoza, Spain, 50009
    • Pfizer Investigational Site
  • Alicante
    • Partida DE Bacarot, Alicante, Spain, 03114
      • Pfizer Investigational Site
  • Asturias
    • Oviedo, Asturias, Spain, 33006
      • Pfizer Investigational Site
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Pfizer Investigational Site
  • Vizcaya
    • Barakaldo, Vizcaya, Spain, 48903
      • Pfizer Investigational Site
• Sweden
  • Goteborg, Sweden, 400 10
    • Pfizer Investigational Site
  • Goteborg, Sweden, 400 14
    • Pfizer Investigational Site
  • Lulea, Sweden, 972 33
    • Pfizer Investigational Site
  • Norrkoping, Sweden, 602 32
    • Pfizer Investigational Site
• Taiwan
  • Kaohsiung Hsien, Taiwan
    • Pfizer Investigational Site
  • Taichung, Taiwan, 407
    • Pfizer Investigational Site
  • Tainan, Taiwan, 407
    • Pfizer Investigational Site
  • Taipei, Taiwan, 114
    • Pfizer Investigational Site
  • Tao-Yuan, Taiwan
    • Pfizer Investigational Site
• Ukraine
  • Dnipropetrovsk, Ukraine, 49008
    • Pfizer Investigational Site
  • Donetsk, Ukraine, 83003
    • Pfizer Investigational Site
  • Donetsk, Ukraine, 83114
    • Pfizer Investigational Site
  • Ivano-Frankivsk, Ukraine, 76018
    • Pfizer Investigational Site
  • Kharkiv, Ukraine, 61178
    • Pfizer Investigational Site
  • Kharkiv, Ukraine, 61002
    • Pfizer Investigational Site
  • Kharkiv, Ukraine, 61018
    • Pfizer Investigational Site
  • Kharkiv, Ukraine, 61037
    • Pfizer Investigational Site
  • Kiev, Ukraine, 01103
    • Pfizer Investigational Site
  • Kyiv, Ukraine, 04053
    • Pfizer Investigational Site
  • Lutsk, Ukraine, 43024
    • Pfizer Investigational Site
  • Lviv, Ukraine, 79013
    • Pfizer Investigational Site
  • Odessa, Ukraine, 65025
    • Pfizer Investigational Site
  • Odessa, Ukraine, 65009
    • Pfizer Investigational Site
  • Odessa, Ukraine, 65026
    • Pfizer Investigational Site
  • Simferopol, Ukraine, 95017
    • Pfizer Investigational Site
  • Zaporizhzhia, Ukraine, 69118
    • Pfizer Investigational Site
• United Kingdom
  • Bexhill on Sea, United Kingdom, TN39 5HE
    • Pfizer Investigational Site
  • Canterbury, United Kingdom, CT1 3HX
    • Pfizer Investigational Site
  • Chesterfield, United Kingdom, S40 4TF
    • Pfizer Investigational Site
  • Glasgow, United Kingdom, G42 7AF
    • Pfizer Investigational Site
  • Peterborough, United Kingdom, PE7 3JL
    • Pfizer Investigational Site
  • Peterborough, United Kingdom, PE2 5GP
    • Pfizer Investigational Site
  • St Leonards on Sea, United Kingdom, TN37 6BG
    • Pfizer Investigational Site
  • Swindon, United Kingdom, SN25 4YZ
    • Pfizer Investigational Site
  • Vale Of Glamorgan, United Kingdom, CF62 7EB
    • Pfizer Investigational Site
  • Wansford, United Kingdom, PE8 6PL
    • Pfizer Investigational Site
  • Argyle & Clyde
    • Helensburgh, Argyle & Clyde, United Kingdom, G84 7QL
      • Pfizer Investigational Site
  • Berks
    • Maidenhead, Berks, United Kingdom, SL6 6EL
      • Pfizer Investigational Site
  • Buckinghamshire
    • Aston Clinton, Buckinghamshire, United Kingdom, HP22 5LB
      • Pfizer Investigational Site
  • Cornwall
    • St Austell, Cornwall, United Kingdom, PL26 7RL
      • Pfizer Investigational Site
  • East Sussex
    • Bexhill on Sea, East Sussex, United Kingdom, TN39 4SP
      • Pfizer Investigational Site
  • Hampshire
    • Aldershot, Hampshire, United Kingdom, GU12 5BA
      • Pfizer Investigational Site
    • Basingstoke, Hampshire, United Kingdom, RG22 4EH
      • Pfizer Investigational Site
    • Odiham, Hampshire, United Kingdom, RG29 1JY
      • Pfizer Investigational Site
  • Middlesex
    • Ashford, Middlesex, United Kingdom, TW15 3EA
      • Pfizer Investigational Site
    • Harrow, Middlesex, United Kingdom, HA3 7LT
      • Pfizer Investigational Site
  • Surrey
    • Camberley, Surrey, United Kingdom, GU15 2NN
      • Pfizer Investigational Site
    • East Horsley, Leatherhead, Surrey, United Kingdom, KT24 6QT
      • Pfizer Investigational Site
  • WEST Sussex
    • Pound Hill, Crawley, WEST Sussex, United Kingdom, RH10 7DX
      • Pfizer Investigational Site
  • Wiltshire
    • Bradford-on-Avon, Wiltshire, United Kingdom, BA1 5DQ
      • Pfizer Investigational Site
    • Chippenham, Wiltshire, United Kingdom, SN14 6GT
      • Pfizer Investigational Site
  • Wirral
    • Upton, Wirral, United Kingdom, L49 5PE
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: B	Drug: Diclofenac + Omeprazole; Participants are assigned to one of two groups in parallel for the duration of the study
Experimental: A	Drug: Celecoxib; Participants are assigned to one of two groups in parallel for the duration of the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With CSULGIES or Symptomatic Ulcers (SUs)	CSULGIE=any of the following: 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 with evaluation at an event visit and found to have an ulcer on endoscopy, but did not meet any criteria considered for the primary endpoint by the GI committee were designated as having an SU.	6 month treatment duration
Change From Baseline in Patient's Global Arthritis Assessment at Month 6/Early Termination (ET)	Subjects rated response to question: "Considering all the ways the osteoarthritis or rheumatoid arthritis affects you, how are you doing today?" using a 1 to 5 grading scale where 1=very good and 5=very poor.	Month 6/Early Termination (ET)
Number of Subjects With SUs	Subjects with evaluation at an event visit and found to have an ulcer on endoscopy, but did not meet any criteria considered for the primary endpoint by the GI committee were designated as having an SU.	6 month treatment duration
Number of Subjects With CSULGIEs by History of GD Ulceration	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
Number of Subjects With Moderate to Severe Abdominal Symptoms	Abdominal symptoms were defined by the Medical Dictionary for Regulatory Activities MedDRA System Organ Class (SOC) 'Gastrointestinal Disorders' and keeping high level group term (HLGT) equal to "Gastrointestinal Signs and Symptoms".	6 month treatment duration
Number of Subjects Withdrawn Due to GI Adverse Events (AEs)	GI AEs were defined using MedDRA SOC "Gastrointestinal Disorders" but excluding the following HLGTs: Benign Neoplasms Gastrointestinal; Dental and Gingival Conditions; Oral Soft Tissue Conditions; Salivary Gland Conditions; and Tongue Conditions.	6 month treatment duration
Change From Baseline in Hemoglobin at Month 6/ET		Month 6/ET
Change From Baseline in Hematocrit at Month 6/ET		Month 6/ET
Number of Subjects With a Clinically Significant Decrease From Baseline in Hematocrit and/or Hemoglobin	A clinically significant decrease from baseline was defined as a fall in hematocrit > = 10 percentage points and/or hemoglobin > = 2 g/dL.	6 month treatment duration
Number of Subjects With Hepatic AEs in Gamma Glutamyl-Transferase (GGT), Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) of 3 Times the Upper Limit of Normal (ULN)	GGT ULN was 49 international units (IU)/liter (L) for females and 61 IU/L for males, AST ULN was 37 IU/L for females and 39 IU/L for males, and ALT ULN was 43 IU/L for females and 45 IU/L for males.	6 month treatment duration
Change From Baseline in Hepatic Measures of GGT, AST or ALT to Month 6/ET		Month 6/ET
Change From Baseline in Iron Binding Capacity to Month 6/ET		Month 6/ET
Change From Baseline in Ferretin to Month 6/ET		Month 6/ET
Change From Baseline in C-Reactive Protein to Month 6/ET		Month 6/ET

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects Alive at the Post Trial Interview	Interview occurred via telephone to obtain follow-up mortality and hospitalization information.	6 months following last dose
Number of Subjects Hospitalized in Last 6 Months at the Post Trial Interview	Interview occurred via telephone to obtain follow-up mortality and hospitalization information.	6 months following last dose

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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. Erratum In: Lancet. 2011 Jul 16;378(9787):228.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: August 29, 2005
• First Submitted That Met QC Criteria: August 31, 2005
• First Posted (Estimate): September 1, 2005

Study Record Updates

• Last Update Posted (Actual): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 1, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: GI events in high risk GI arthritis patients
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Osteoarthritis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Gastrointestinal Agents; Cyclooxygenase 2 Inhibitors; Anti-Ulcer Agents; Proton Pump Inhibitors; Celecoxib; Diclofenac; Omeprazole
• Other Study ID Numbers: A3191084