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NCT00141102 Clinical Trial

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
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 2005
Est. completion date May 2009

Study information
Verified date March 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
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