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

Osteoarthritis Clinical Trial

— CONDOR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00141102
• Other study ID #: A3191084
• Status: Completed
• Phase: Phase 4
• Start date: October 2005
• Est. completion date: May 2009

Study information

• Verified date: March 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4484
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Osteoarthritis

Intervention

Drug:
• Celecoxib
Participants are assigned to one of two groups in parallel for the duration of the study
• Diclofenac + Omeprazole
Participants are assigned to one of two groups in parallel for the duration of the study

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Genk
Belgium	Pfizer Investigational Site	Gent
Belgium	Pfizer Investigational Site	Hasselt
Belgium	Pfizer Investigational Site	Liège
Brazil	Pfizer Investigational Site	Curitiba	PR
Brazil	Pfizer Investigational Site	Curitiba	PR
Brazil	Pfizer Investigational Site	Goiânia	GO
Brazil	Pfizer Investigational Site	Goiânia	GO
Brazil	Pfizer Investigational Site	Porto Alegre	RS
Brazil	Pfizer Investigational Site	Rio de Janeiro	RJ
Brazil	Pfizer Investigational Site	Sao Paulo	SP
Brazil	Pfizer Investigational Site	São Paulo	SP
Brazil	Pfizer Investigational Site	São Paulo	SP
Canada	Pfizer Investigational Site	Hamilton	Ontario
Canada	Pfizer Investigational Site	Newmarket	Ontario
Canada	Pfizer Investigational Site	Pointe Claire	Quebec
Canada	Pfizer Investigational Site	Sherbrooke	Quebec
Canada	Pfizer Investigational Site	St. John's	Newfoundland and Labrador
Canada	Pfizer Investigational Site	Ste Foy	Quebec
Canada	Pfizer Investigational Site	Windsor	Ontario
Canada	Pfizer Investigational Site	Winnipeg	Manitoba
China	Pfizer Investigational Site	Beijing
China	Pfizer Investigational Site	Beijing
China	Pfizer Investigational Site	Beijing
China	Pfizer Investigational Site	Beijing
China	Pfizer Investigational Site	Chengdu	Sichuan
China	Pfizer Investigational Site	Guangzhou	Guangdong
China	Pfizer Investigational Site	Nanjing	Jiangsu
China	Pfizer Investigational Site	Shanghai
China	Pfizer Investigational Site	Shanghai
China	Pfizer Investigational Site	Tianjin
China	Pfizer Investigational Site	Tianjin
Colombia	Pfizer Investigational Site	Barranquilla	Atlantico
Colombia	Pfizer Investigational Site	Barranquilla	Atlantico
Colombia	Pfizer Investigational Site	Bogota	Cundinamarca
Colombia	Pfizer Investigational Site	Floridablanca	Santander
Colombia	Pfizer Investigational Site	Medellin	Antioquia
Costa Rica	Pfizer Investigational Site	Cartago
Costa Rica	Pfizer Investigational Site	Heredia
Costa Rica	Pfizer Investigational Site	San Jose
Costa Rica	Pfizer Investigational Site	San Jose
Croatia	Pfizer Investigational Site	Opatija
Croatia	Pfizer Investigational Site	Zagreb
Czechia	Pfizer Investigational Site	Ceske Budejovice
Czechia	Pfizer Investigational Site	Hradec Kralove
Czechia	Pfizer Investigational Site	Ostrava	Trebovice
Czechia	Pfizer Investigational Site	Plzen	Bory
Czechia	Pfizer Investigational Site	Prague 1
Czechia	Pfizer Investigational Site	Praha 2
Czechia	Pfizer Investigational Site	Praha 2
Czechia	Pfizer Investigational Site	Praha 4
Czechia	Pfizer Investigational Site	Praha 6
Ecuador	Pfizer Investigational Site	Cuenca	Azuay
Ecuador	Pfizer Investigational Site	Guayaquil	Guayas
Ecuador	Pfizer Investigational Site	Quito	Pichincha
Estonia	Pfizer Investigational Site	Tallinn
Estonia	Pfizer Investigational Site	Tallinn
Estonia	Pfizer Investigational Site	Tartu
France	Pfizer Investigational Site	Amiens
France	Pfizer Investigational Site	Dijon
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Deggingen
Germany	Pfizer Investigational Site	Dresden
Germany	Pfizer Investigational Site	Hamburg
Germany	Pfizer Investigational Site	Hamburg
Germany	Pfizer Investigational Site	Hoyerswerda
Germany	Pfizer Investigational Site	Kuenzing
Germany	Pfizer Investigational Site	Muenchen
Germany	Pfizer Investigational Site	Nuernberg
Greece	Pfizer Investigational Site	Thessaloniki
Guatemala	Pfizer Investigational Site	Ciudad de Guatemala
Guatemala	Pfizer Investigational Site	Guatemala 01010
Hong Kong	Pfizer Investigational Site	Lai Chi Kok
Hong Kong	Pfizer Investigational Site	Shatin
India	Pfizer Investigational Site	Bangalore	Karnataka
India	Pfizer Investigational Site	Bangalore	Karnataka
India	Pfizer Investigational Site	Bangalore	Karnataka
India	Pfizer Investigational Site	Hyderabad	Andhra Pradesh
India	Pfizer Investigational Site	Ludhiana	Punjab
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Latvia	Pfizer Investigational Site	Riga
Latvia	Pfizer Investigational Site	Riga
Latvia	Pfizer Investigational Site	Riga
Lithuania	Pfizer Investigational Site	Alytus
Lithuania	Pfizer Investigational Site	Kaunas
Lithuania	Pfizer Investigational Site	Kaunas
Lithuania	Pfizer Investigational Site	Klaipeda
Lithuania	Pfizer Investigational Site	Vilnius
Netherlands	Pfizer Investigational Site	Alkmaar
Netherlands	Pfizer Investigational Site	Leidschendam
Netherlands	Pfizer Investigational Site	Vlaardingen	ZH
Panama	Pfizer Investigational Site	Ciudad de Panama
Peru	Pfizer Investigational Site	Lima
Peru	Pfizer Investigational Site	Lima
Peru	Pfizer Investigational Site	Lima
Peru	Pfizer Investigational Site	Lima
Peru	Pfizer Investigational Site	Surco	Lima
Portugal	Pfizer Investigational Site	Lisboa
Portugal	Pfizer Investigational Site	Lisboa
Portugal	Pfizer Investigational Site	Lisbon
Portugal	Pfizer Investigational Site	Ponta Delgada
Portugal	Pfizer Investigational Site	Ponte de Lima
Portugal	Pfizer Investigational Site	Ponte de Lima
Russian Federation	Pfizer Investigational Site	Ekaterinburg
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Petrozavodsk
Russian Federation	Pfizer Investigational Site	Smolensk
Russian Federation	Pfizer Investigational Site	St. Petersburg
Russian Federation	Pfizer Investigational Site	St. Petersburg
Serbia	Pfizer Investigational Site	Belgrade
Serbia	Pfizer Investigational Site	Niska Banja
Serbia	Pfizer Investigational Site	Novi Sad
Singapore	Pfizer Investigational Site	Sinapore
Singapore	Pfizer Investigational Site	Singapore
Singapore	Pfizer Investigational Site	Singapore
South Africa	Pfizer Investigational Site	Bellville
South Africa	Pfizer Investigational Site	Bloemfontein	Free State
South Africa	Pfizer Investigational Site	Cape Town
South Africa	Pfizer Investigational Site	Durban	KZN
South Africa	Pfizer Investigational Site	Johannesburg	Gauteng Province
South Africa	Pfizer Investigational Site	Kempton Park
South Africa	Pfizer Investigational Site	Observatory Cape Town
South Africa	Pfizer Investigational Site	Parow	Western Cape
Spain	Pfizer Investigational Site	Avila
Spain	Pfizer Investigational Site	Barakaldo	Vizcaya
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Oviedo	Asturias
Spain	Pfizer Investigational Site	Partida DE Bacarot	Alicante
Spain	Pfizer Investigational Site	Sabadell	Barcelona
Spain	Pfizer Investigational Site	Zaragoza
Sweden	Pfizer Investigational Site	Goteborg
Sweden	Pfizer Investigational Site	Goteborg
Sweden	Pfizer Investigational Site	Lulea
Sweden	Pfizer Investigational Site	Norrkoping
Taiwan	Pfizer Investigational Site	Kaohsiung Hsien
Taiwan	Pfizer Investigational Site	Taichung
Taiwan	Pfizer Investigational Site	Tainan
Taiwan	Pfizer Investigational Site	Taipei
Taiwan	Pfizer Investigational Site	Tao-Yuan
Ukraine	Pfizer Investigational Site	Dnipropetrovsk
Ukraine	Pfizer Investigational Site	Donetsk
Ukraine	Pfizer Investigational Site	Donetsk
Ukraine	Pfizer Investigational Site	Ivano-Frankivsk
Ukraine	Pfizer Investigational Site	Kharkiv
Ukraine	Pfizer Investigational Site	Kharkiv
Ukraine	Pfizer Investigational Site	Kharkiv
Ukraine	Pfizer Investigational Site	Kharkiv
Ukraine	Pfizer Investigational Site	Kiev
Ukraine	Pfizer Investigational Site	Kyiv
Ukraine	Pfizer Investigational Site	Lutsk
Ukraine	Pfizer Investigational Site	Lviv
Ukraine	Pfizer Investigational Site	Odessa
Ukraine	Pfizer Investigational Site	Odessa
Ukraine	Pfizer Investigational Site	Odessa
Ukraine	Pfizer Investigational Site	Simferopol
Ukraine	Pfizer Investigational Site	Zaporizhzhia
United Kingdom	Pfizer Investigational Site	Aldershot	Hampshire
United Kingdom	Pfizer Investigational Site	Ashford	Middlesex
United Kingdom	Pfizer Investigational Site	Aston Clinton	Buckinghamshire
United Kingdom	Pfizer Investigational Site	Basingstoke	Hampshire
United Kingdom	Pfizer Investigational Site	Bexhill on Sea
United Kingdom	Pfizer Investigational Site	Bexhill on Sea	East Sussex
United Kingdom	Pfizer Investigational Site	Bradford-on-Avon	Wiltshire
United Kingdom	Pfizer Investigational Site	Camberley	Surrey
United Kingdom	Pfizer Investigational Site	Canterbury
United Kingdom	Pfizer Investigational Site	Chesterfield
United Kingdom	Pfizer Investigational Site	Chippenham	Wiltshire
United Kingdom	Pfizer Investigational Site	East Horsley, Leatherhead	Surrey
United Kingdom	Pfizer Investigational Site	Glasgow
United Kingdom	Pfizer Investigational Site	Harrow	Middlesex
United Kingdom	Pfizer Investigational Site	Helensburgh	Argyle & Clyde
United Kingdom	Pfizer Investigational Site	Maidenhead	Berks
United Kingdom	Pfizer Investigational Site	Odiham	Hampshire
United Kingdom	Pfizer Investigational Site	Peterborough
United Kingdom	Pfizer Investigational Site	Peterborough
United Kingdom	Pfizer Investigational Site	Pound Hill, Crawley	WEST Sussex
United Kingdom	Pfizer Investigational Site	St Austell	Cornwall
United Kingdom	Pfizer Investigational Site	St Leonards on Sea
United Kingdom	Pfizer Investigational Site	Swindon
United Kingdom	Pfizer Investigational Site	Upton	Wirral
United Kingdom	Pfizer Investigational Site	Vale Of Glamorgan
United Kingdom	Pfizer Investigational Site	Wansford

Sponsors (1)

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

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change From Baseline in Hemoglobin at Month 6/ET		Month 6/ET
Secondary	Change From Baseline in Hematocrit at Month 6/ET		Month 6/ET
Secondary	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
Secondary	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
Secondary	Change From Baseline in Hepatic Measures of GGT, AST or ALT to Month 6/ET		Month 6/ET
Secondary	Change From Baseline in Iron Binding Capacity to Month 6/ET		Month 6/ET
Secondary	Change From Baseline in Ferretin to Month 6/ET		Month 6/ET
Secondary	Change From Baseline in C-Reactive Protein to Month 6/ET		Month 6/ET

External Links

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