OsteoarthritisPhase 4CONDORNCT00141102

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

A Phase 4 study testing Celecoxib and Diclofenac + Omeprazole in people with Osteoarthritis and Arthritis, Rheumatoid, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 194 sites in 32 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Osteoarthritis, Arthritis, Rheumatoid
What is being tested?: Celecoxib and Diclofenac + Omeprazole
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4,484 participants
Where: 194 sitesin 32 countries
Study dates: Oct 2005to May 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

194 sites in 32 countries.

Country

City, postcode or hospital

194 sites in 32 countries

United Kingdom26 sites

Pfizer Investigational Site
Aldershot, Hampshire, GU12 5BA
Pfizer Investigational Site
Ashford, Middlesex, TW15 3EA
Pfizer Investigational Site
Aston Clinton, Buckinghamshire, HP22 5LB
Pfizer Investigational Site
Basingstoke, Hampshire, RG22 4EH
Pfizer Investigational Site
Bexhill-on-Sea, East Sussex, TN39 4SP
Pfizer Investigational Site
Bexhill-on-Sea, TN39 5HE
Pfizer Investigational Site
Bradford on Avon, Wiltshire, BA1 5DQ
Pfizer Investigational Site
Camberley, Surrey, GU15 2NN
Pfizer Investigational Site
Canterbury, CT1 3HX
Pfizer Investigational Site
Chesterfield, S40 4TF
Pfizer Investigational Site
Chippenham, Wiltshire, SN14 6GT
Pfizer Investigational Site
East Horsley, Leatherhead, Surrey, KT24 6QT
Pfizer Investigational Site
Glasgow, G42 7AF
Pfizer Investigational Site
Harrow, Middlesex, HA3 7LT
Pfizer Investigational Site
Helensburgh, Argyle & Clyde, G84 7QL
Pfizer Investigational Site
Maidenhead, Berks, SL6 6EL
Pfizer Investigational Site
Odiham, Hampshire, RG29 1JY
Pfizer Investigational Site
Peterborough, PE2 5GP
Pfizer Investigational Site
Peterborough, PE7 3JL
Pfizer Investigational Site
Pound Hill, Crawley, WEST Sussex, RH10 7DX
Pfizer Investigational Site
Saint Leonards-on-Sea, TN37 6BG
Pfizer Investigational Site
St Austell, Cornwall, PL26 7RL
Pfizer Investigational Site
Swindon, SN25 4YZ
Pfizer Investigational Site
Upton, Wirral, L49 5PE
Pfizer Investigational Site
Vale of Glamorgan, CF62 7EB
Pfizer Investigational Site
Wansford, PE8 6PL

Other trials in United Kingdom

Ukraine17 sites

Pfizer Investigational Site
Dnipropetrovsk, 49008
Pfizer Investigational Site
Donetsk, 83003
Pfizer Investigational Site
Donetsk, 83114
Pfizer Investigational Site
Ivano-Frankivsk, 76018
Pfizer Investigational Site
Kharkiv, 61002
Pfizer Investigational Site
Kharkiv, 61018
Pfizer Investigational Site
Kharkiv, 61037
Pfizer Investigational Site
Kharkiv, 61178
Pfizer Investigational Site
Kiev, 01103
Pfizer Investigational Site
Kyiv, 04053
Pfizer Investigational Site
Lutsk, 43024
Pfizer Investigational Site
Lviv, 79013
Pfizer Investigational Site
Odesa, 65009
Pfizer Investigational Site
Odesa, 65025
Pfizer Investigational Site
Odesa, 65026
Pfizer Investigational Site
Simferopol, 95017
Pfizer Investigational Site
Zaporizhzhya, 69118

Other trials in Ukraine

China11 sites

Pfizer Investigational Site
Beijing, 100020
Pfizer Investigational Site
Beijing, 100044
Pfizer Investigational Site
Beijing, 100073
Pfizer Investigational Site
Beijing, 100853
Pfizer Investigational Site
Chengdu, Sichuan, 610041
Pfizer Investigational Site
Guangzhou, Guangdong, 510630
Pfizer Investigational Site
Nanjing, Jiangsu, 210008
Pfizer Investigational Site
Shanghai, 200001
Pfizer Investigational Site
Shanghai, 200040
Pfizer Investigational Site
Tianjin, 300052
Pfizer Investigational Site
Tianjin, 300192

Other trials in China

Russia11 sites

Pfizer Investigational Site
Moscow, 109004
Pfizer Investigational Site
Moscow, 109240
Pfizer Investigational Site
Moscow, 109388
Pfizer Investigational Site
Moscow, 113093
Pfizer Investigational Site
Moscow, 115522
Pfizer Investigational Site
Moscow, 118089
Pfizer Investigational Site
Petrozavodsk, 185019
Pfizer Investigational Site
Saint Petersburg, 190000
Pfizer Investigational Site
Saint Petersburg
Pfizer Investigational Site
Smolensk, 214019
Pfizer Investigational Site
Yekaterinburg, 620043

Other trials in Russia

Germany10 sites

Pfizer Investigational Site
Berlin, 12247
Pfizer Investigational Site
Berlin, 13125
Pfizer Investigational Site
Deggingen, 73326
Pfizer Investigational Site
Dresden, 01129
Pfizer Investigational Site
Hamburg, 22143
Pfizer Investigational Site
Hamburg, 22415
Pfizer Investigational Site
Hoyerswerda, 02977
Pfizer Investigational Site
Künzing, 94550
Pfizer Investigational Site
München, 80639
Pfizer Investigational Site
Nuremberg, 90402

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Spain10 sites

Pfizer Investigational Site
Ávila, 05004
Pfizer Investigational Site
Barakaldo, Vizcaya, 48903
Pfizer Investigational Site
Barcelona, 08036
Pfizer Investigational Site
Barcelona, 08041
Pfizer Investigational Site
Madrid, 28009
Pfizer Investigational Site
Madrid, 28046
Pfizer Investigational Site
Oviedo, Principality of Asturias, 33006
Pfizer Investigational Site
Partida de Bacarot, Alicante, 03114
Pfizer Investigational Site
Sabadell, Barcelona, 08208
Pfizer Investigational Site
Zaragoza, 50009

Other trials in Spain

Brazil9 sites

Pfizer Investigational Site
Curitiba, Paraná, 80060-240
Pfizer Investigational Site
Curitiba, Paraná, 80060-900
Pfizer Investigational Site
Goiânia, Goiás, 74043-110
Pfizer Investigational Site
Goiânia, Goiás, 74110-120
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-903
Pfizer Investigational Site
Rio de Janeiro, Rio de Janeiro, 22271-100
Pfizer Investigational Site
São Paulo, São Paulo, 04230-000
Pfizer Investigational Site
São Paulo, São Paulo, 05403-010
Pfizer Investigational Site
São Paulo, São Paulo, 05437-010

Other trials in Brazil

Czechia9 sites

Pfizer Investigational Site
České Budějovice, 370 01
Pfizer Investigational Site
Hradec Králové, 50012
Pfizer Investigational Site
Ostrava, Trebovice, 722 00
Pfizer Investigational Site
Pilsen, Bory, 30599
Pfizer Investigational Site
Prague, 118 00
Pfizer Investigational Site
Prague, 120 00
Pfizer Investigational Site
Prague, 128 50
Pfizer Investigational Site
Prague, 140 59
Pfizer Investigational Site
Prague, 16900

Other trials in Czechia

Canada8 sites

Pfizer Investigational Site
Hamilton, Ontario, L8N 1Y2
Pfizer Investigational Site
Newmarket, Ontario, L3Y 3R7
Pfizer Investigational Site
Pointe-Claire, Quebec, H9R 3J1
Pfizer Investigational Site
Sherbrooke, Quebec, J1H 5N4
Pfizer Investigational Site
St. John's, Newfoundland and Labrador, A1B 3E1
Pfizer Investigational Site
Ste Foy, Quebec, G1V 3M7
Pfizer Investigational Site
Windsor, Ontario, N8X 5A6
Pfizer Investigational Site
Winnipeg, Manitoba, R3A 1M3

Other trials in Canada

South Africa8 sites

Pfizer Investigational Site
Bellville, 7530
Pfizer Investigational Site
Bloemfontein, Free State, 9310
Pfizer Investigational Site
Cape Town
Pfizer Investigational Site
Durban, KwaZulu-Natal, 4091
Pfizer Investigational Site
Johannesburg, Gauteng, 2193
Pfizer Investigational Site
Kempton Park
Pfizer Investigational Site
Observatory Cape Town, 7925
Pfizer Investigational Site
Parow, Western Cape, 7500

Other trials in South Africa

Portugal6 sites

Pfizer Investigational Site
Lisbon, 1000-247
Pfizer Investigational Site
Lisbon, 1249-075
Pfizer Investigational Site
Lisbon, 1600-035
Pfizer Investigational Site
Ponta Delgada, 9500-370
Pfizer Investigational Site
Ponte de Lima, 4990-049
Pfizer Investigational Site
Ponte de Lima, 4990-49

Other trials in Portugal

Colombia5 sites

Pfizer Investigational Site
Barranquilla, Atlántico, 0
Pfizer Investigational Site
Barranquilla, Atlántico
Pfizer Investigational Site
Bogota, Cundinamarca, 0
Pfizer Investigational Site
Floridablanca, Santander Department, 0
Pfizer Investigational Site
Medellín, Antioquia, 0

Other trials in Colombia

India5 sites

Pfizer Investigational Site
Bangalore, Karnataka, 560 034
Pfizer Investigational Site
Bangalore, Karnataka, 560 079
Pfizer Investigational Site
Bangalore, Karnataka, 560054
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, 500 033
Pfizer Investigational Site
Ludhiana, Punjab, 141 001

Other trials in India

Lithuania5 sites

Pfizer Investigational Site
Alytus, LT-62114
Pfizer Investigational Site
Kaunas, LT-47144
Pfizer Investigational Site
Kaunas, LT-50425
Pfizer Investigational Site
Klaipėda, LT-94231
Pfizer Investigational Site
Vilnius, LT-07156

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Peru5 sites

Pfizer Investigational Site
Lima, 27
Pfizer Investigational Site
Lima, L11
Pfizer Investigational Site
Lima, Lima 27
Pfizer Investigational Site
Lima, Lima 29
Pfizer Investigational Site
Surco, Lima region, Lima 33

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South Korea5 sites

Pfizer Investigational Site
Seoul, 110-744
Pfizer Investigational Site
Seoul, 133-792
Pfizer Investigational Site
Seoul, 135-710
Pfizer Investigational Site
Seoul, 137-040
Pfizer Investigational Site
Seoul, 138-736

Other trials in South Korea

Taiwan5 sites

Pfizer Investigational Site
Kaohsiung Hsien
Pfizer Investigational Site
Taichung, 407
Pfizer Investigational Site
Tainan, 407
Pfizer Investigational Site
Taipei, 114
Pfizer Investigational Site
Taoyuan

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Belgium4 sites

Pfizer Investigational Site
Genk, 3600
Pfizer Investigational Site
Ghent, 9000
Pfizer Investigational Site
Hasselt, 3500
Pfizer Investigational Site
Liège, 4000

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Costa Rica4 sites

Pfizer Investigational Site
Cartago
Pfizer Investigational Site
Heredia
Pfizer Investigational Site
San José, 3er piso.
Pfizer Investigational Site
San José

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Sweden4 sites

Pfizer Investigational Site
Gothenburg, 400 10
Pfizer Investigational Site
Gothenburg, 400 14
Pfizer Investigational Site
Luleå, 972 33
Pfizer Investigational Site
Norrköping, 602 32

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Ecuador3 sites

Pfizer Investigational Site
Cuenca, Azuay
Pfizer Investigational Site
Guayaquil, Guayas
Pfizer Investigational Site
Quito, Pichincha

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Estonia3 sites

Pfizer Investigational Site
Tallinn, 11312
Pfizer Investigational Site
Tallinn, 13419
Pfizer Investigational Site
Tartu, 51007

Other trials in Estonia

Latvia3 sites

Pfizer Investigational Site
Riga, LV 1002
Pfizer Investigational Site
Riga, LV 1006
Pfizer Investigational Site
Riga, LV 1038

Other trials in Latvia

Netherlands3 sites

Pfizer Investigational Site
Alkmaar, 1815 JD
Pfizer Investigational Site
Leidschendam, 2262 BA
Pfizer Investigational Site
Vlaardingen, South Holland, 3136 LA

Other trials in Netherlands

Serbia3 sites

Pfizer Investigational Site
Belgrade, 11000
Pfizer Investigational Site
Niška Banja, 18205
Pfizer Investigational Site
Novi Sad, 21000

Other trials in Serbia

Singapore3 sites

Pfizer Investigational Site
Sinapore, 308433
Pfizer Investigational Site
Singapore, 119074
Pfizer Investigational Site
Singapore, 529889

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Croatia2 sites

Pfizer Investigational Site
Opatija, 51410
Pfizer Investigational Site
Zagreb, 10000

Other trials in Croatia

France2 sites

Pfizer Investigational Site
Amiens, 80030
Pfizer Investigational Site
Dijon, 21000

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Hong Kong2 sites

Pfizer Investigational Site
Lai Chi Kok
Pfizer Investigational Site
Shatin

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Greece1 site

Pfizer Investigational Site
Thessaloniki, 54 636

Other trials in Greece

Guatemala1 site

Pfizer Investigational Site
Guatemala City

Other trials in Guatemala

Panama1 site

Pfizer Investigational Site
Panama City

Other trials in Panama

About this study

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

Conditions: Osteoarthritis, Arthritis, Rheumatoid
Being tested: Celecoxib, Diclofenac + Omeprazole
Keywords: GI events in high risk GI arthritis patients
Medical subject headings: Osteoarthritis, Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CelecoxibDrug
Participants are assigned to one of two groups in parallel for the duration of the study
Diclofenac + OmeprazoleDrug
Participants are assigned to one of two groups in parallel for the duration of the study

Study groups in NCT00141102
Study group	Role	What they receive
A	Experimental	Not described Receives: Drug: Celecoxib
B	Active comparator	Not described Receives: Drug: Diclofenac + Omeprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 month treatment duration

Secondary outcomes (14)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 6 month treatment duration
Change From Baseline in Hemoglobin at Month 6/ET
Measured: Month 6/ET
Change From Baseline in Hematocrit at Month 6/ET
Measured: 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.
Measured: 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.
Measured: 6 month treatment duration
Change From Baseline in Hepatic Measures of GGT, AST or ALT to Month 6/ET
Measured: Month 6/ET
Change From Baseline in Iron Binding Capacity to Month 6/ET
Measured: Month 6/ET
Change From Baseline in Ferretin to Month 6/ET
Measured: Month 6/ET
Change From Baseline in C-Reactive Protein to Month 6/ET
Measured: Month 6/ET

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2005May 2009

First posted1 Sep 2005 (estimated)
Study startOct 2005
Primary completionMay 2009
Study completionMay 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for OsteoarthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 4,484 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00141102
Sponsor's protocol ID: A3191084
Acronym: CONDOR
Status last verified: Mar 2021
First submitted: 29 Aug 2005
Last updated: 3 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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.
PubMed 24358067
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.
PubMed 20638563

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00141102
Acronym / sponsor ID: CONDOR / A3191084
Conditions: Osteoarthritis, Arthritis, Rheumatoid
Keywords: GI events in high risk GI arthritis patients
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 4,484 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Oct 2005
Primary completion: May 2009 (actual)
Study completion: May 2009 (actual)
First posted: 1 Sep 2005 (estimated)
Results: Posted 11 Jun 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
A	Experimental	Drug: Celecoxib
B	Active comparator	Drug: Diclofenac + Omeprazole

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CelecoxibParticipants are assigned to one of two groups in parallel for the duration of the study	Drug	A
Diclofenac + OmeprazoleParticipants are assigned to one of two groups in parallel for the duration of the study	Drug	B

Primary outcome

Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs)
Time frame: 6 month treatment duration
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.

14 secondary outcomes

Number of Subjects With CSULGIES or Symptomatic Ulcers (SUs)
Time frame: 6 month treatment duration
Change From Baseline in Patient's Global Arthritis Assessment at Month 6/Early Termination (ET)
Time frame: Month 6/Early Termination (ET)
Number of Subjects With SUs
Time frame: 6 month treatment duration
Number of Subjects With CSULGIEs by History of GD Ulceration
Time frame: 6 month treatment duration
Number of Subjects With Moderate to Severe Abdominal Symptoms
Time frame: 6 month treatment duration
Number of Subjects Withdrawn Due to GI Adverse Events (AEs)
Time frame: 6 month treatment duration
Change From Baseline in Hemoglobin at Month 6/ET
Time frame: Month 6/ET
Change From Baseline in Hematocrit at Month 6/ET
Time frame: Month 6/ET
Number of Subjects With a Clinically Significant Decrease From Baseline in Hematocrit and/or Hemoglobin
Time frame: 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)
Time frame: 6 month treatment duration
Change From Baseline in Hepatic Measures of GGT, AST or ALT to Month 6/ET
Time frame: Month 6/ET
Change From Baseline in Iron Binding Capacity to Month 6/ET
Time frame: Month 6/ET
Change From Baseline in Ferretin to Month 6/ET
Time frame: Month 6/ET
Change From Baseline in C-Reactive Protein to Month 6/ET
Time frame: Month 6/ET

Results and safety

Results posted to the registry on 11 Jun 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Celecoxib	2,238	1,730
Oral Diclofenac Plus Omeprazole	2,246	1,621

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

Time frame: 6 month treatment duration. Number. Unit: participants

Measure	Celecoxib n = 2238	Oral Diclofenac Plus Omeprazole n = 2246
Value	20	81

Celecoxib vs Oral Diclofenac Plus Omeprazole: Odds Ratio (OR): 4.32, p <0.0001, Life Table Extension

Population analysed: Intent-to-Treat (ITT) = included all randomized subjects. n = number of subjects with events confirmed by the committee.

14 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Celecoxib	61 of 2,223 (2.7%)	530 of 2,223 (23.8%)	Not reported
Oral Diclofenac Plus Omeprazole	61 of 2,237 (2.7%)	669 of 2,237 (29.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24358067Kellner 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.
Derived from this study: PubMed 20638563Chan 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.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

194 sites in 32 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 194 sites in United Kingdom, Ukraine, China, Russia, Germany and 27 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jun 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs) (time frame: 6 month treatment duration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00141102, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.