Clinical trial NCT00141102: Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Arthritis, Rheumatoid
Keywords: GI events in high risk GI arthritis patients
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 4484
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs)
timeFrame: 6 month treatment duration
Secondary outcomes:
measure: Number of Subjects With CSULGIES or Symptomatic Ulcers (SUs)
timeFrame: 6 month treatment duration
measure: Change From Baseline in Patient's Global Arthritis Assessment at Month 6/Early Termination (ET)
timeFrame: Month 6/Early Termination (ET)
measure: Number of Subjects With SUs
timeFrame: 6 month treatment duration
measure: Number of Subjects With CSULGIEs by History of GD Ulceration
timeFrame: 6 month treatment duration
measure: Number of Subjects With Moderate to Severe Abdominal Symptoms
timeFrame: 6 month treatment duration
measure: Number of Subjects Withdrawn Due to GI Adverse Events (AEs)
timeFrame: 6 month treatment duration
measure: Change From Baseline in Hemoglobin at Month 6/ET
timeFrame: Month 6/ET
measure: Change From Baseline in Hematocrit at Month 6/ET
timeFrame: Month 6/ET
measure: Number of Subjects With a Clinically Significant Decrease From Baseline in Hematocrit and/or Hemoglobin
timeFrame: 6 month treatment duration
measure: 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)
timeFrame: 6 month treatment duration
measure: Change From Baseline in Hepatic Measures of GGT, AST or ALT to Month 6/ET
timeFrame: Month 6/ET
measure: Change From Baseline in Iron Binding Capacity to Month 6/ET
timeFrame: Month 6/ET
measure: Change From Baseline in Ferretin to Month 6/ET
timeFrame: Month 6/ET
measure: Change From Baseline in C-Reactive Protein to Month 6/ET
timeFrame: Month 6/ET
Other outcomes:
measure: Number of Subjects Alive at the Post Trial Interview
timeFrame: 6 months following last dose
measure: Number of Subjects Hospitalized in Last 6 Months at the Post Trial Interview
timeFrame: 6 months following last dose
Locations:
city: Genk
country: Belgium
facility: Pfizer Investigational Site
city: Gent
country: Belgium
facility: Pfizer Investigational Site
city: Hasselt
country: Belgium
facility: Pfizer Investigational Site
city: Liège
country: Belgium
facility: Pfizer Investigational Site
city: Goiânia
country: Brazil
facility: Pfizer Investigational Site
state: GO
city: Goiânia
country: Brazil
facility: Pfizer Investigational Site
state: GO
city: Curitiba
country: Brazil
facility: Pfizer Investigational Site
state: PR
city: Curitiba
country: Brazil
facility: Pfizer Investigational Site
state: PR
city: Rio de Janeiro
country: Brazil
facility: Pfizer Investigational Site
state: RJ
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: St. John's
country: Canada
facility: Pfizer Investigational Site
state: Newfoundland and Labrador
city: Hamilton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Newmarket
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Windsor
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Pointe Claire
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Ste Foy
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Guangzhou
country: China
facility: Pfizer Investigational Site
state: Guangdong
city: Nanjing
country: China
facility: Pfizer Investigational Site
state: Jiangsu
city: Chengdu
country: China
facility: Pfizer Investigational Site
state: Sichuan
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Tianjin
country: China
facility: Pfizer Investigational Site
city: Tianjin
country: China
facility: Pfizer Investigational Site
city: Medellin
country: Colombia
facility: Pfizer Investigational Site
state: Antioquia
city: Barranquilla
country: Colombia
facility: Pfizer Investigational Site
state: Atlantico
city: Barranquilla
country: Colombia
facility: Pfizer Investigational Site
state: Atlantico
city: Bogota
country: Colombia
facility: Pfizer Investigational Site
state: Cundinamarca
city: Floridablanca
country: Colombia
facility: Pfizer Investigational Site
state: Santander
city: Cartago
country: Costa Rica
facility: Pfizer Investigational Site
city: Heredia
country: Costa Rica
facility: Pfizer Investigational Site
city: San Jose
country: Costa Rica
facility: Pfizer Investigational Site
city: San Jose
country: Costa Rica
facility: Pfizer Investigational Site
city: Opatija
country: Croatia
facility: Pfizer Investigational Site
city: Zagreb
country: Croatia
facility: Pfizer Investigational Site
city: Plzen
country: Czechia
facility: Pfizer Investigational Site
state: Bory
city: Ostrava
country: Czechia
facility: Pfizer Investigational Site
state: Trebovice
city: Ceske Budejovice
country: Czechia
facility: Pfizer Investigational Site
city: Hradec Kralove
country: Czechia
facility: Pfizer Investigational Site
city: Prague 1
country: Czechia
facility: Pfizer Investigational Site
city: Praha 2
country: Czechia
facility: Pfizer Investigational Site
city: Praha 2
country: Czechia
facility: Pfizer Investigational Site
city: Praha 4
country: Czechia
facility: Pfizer Investigational Site
city: Praha 6
country: Czechia
facility: Pfizer Investigational Site
city: Cuenca
country: Ecuador
facility: Pfizer Investigational Site
state: Azuay
city: Guayaquil
country: Ecuador
facility: Pfizer Investigational Site
state: Guayas
city: Quito
country: Ecuador
facility: Pfizer Investigational Site
state: Pichincha
city: Tallinn
country: Estonia
facility: Pfizer Investigational Site
city: Tallinn
country: Estonia
facility: Pfizer Investigational Site
city: Tartu
country: Estonia
facility: Pfizer Investigational Site
city: Amiens
country: France
facility: Pfizer Investigational Site
city: Dijon
country: France
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Deggingen
country: Germany
facility: Pfizer Investigational Site
city: Dresden
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Hoyerswerda
country: Germany
facility: Pfizer Investigational Site
city: Kuenzing
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Nuernberg
country: Germany
facility: Pfizer Investigational Site
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
city: Ciudad de Guatemala
country: Guatemala
facility: Pfizer Investigational Site
city: Guatemala 01010
country: Guatemala
facility: Pfizer Investigational Site
city: Lai Chi Kok
country: Hong Kong
facility: Pfizer Investigational Site
city: Shatin
country: Hong Kong
facility: Pfizer Investigational Site
city: Hyderabad
country: India
facility: Pfizer Investigational Site
state: Andhra Pradesh
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Ludhiana
country: India
facility: Pfizer Investigational Site
state: Punjab
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Riga
country: Latvia
facility: Pfizer Investigational Site
city: Riga
country: Latvia
facility: Pfizer Investigational Site
city: Riga
country: Latvia
facility: Pfizer Investigational Site
city: Alytus
country: Lithuania
facility: Pfizer Investigational Site
city: Kaunas
country: Lithuania
facility: Pfizer Investigational Site
city: Kaunas
country: Lithuania
facility: Pfizer Investigational Site
city: Klaipeda
country: Lithuania
facility: Pfizer Investigational Site
city: Vilnius
country: Lithuania
facility: Pfizer Investigational Site
city: Vlaardingen
country: Netherlands
facility: Pfizer Investigational Site
state: ZH
city: Alkmaar
country: Netherlands
facility: Pfizer Investigational Site
city: Leidschendam
country: Netherlands
facility: Pfizer Investigational Site
city: Ciudad de Panama
country: Panama
facility: Pfizer Investigational Site
city: Surco
country: Peru
facility: Pfizer Investigational Site
state: Lima
city: Lima
country: Peru
facility: Pfizer Investigational Site
city: Lima
country: Peru
facility: Pfizer Investigational Site
city: Lima
country: Peru
facility: Pfizer Investigational Site
city: Lima
country: Peru
facility: Pfizer Investigational Site
city: Lisboa
country: Portugal
facility: Pfizer Investigational Site
city: Lisboa
country: Portugal
facility: Pfizer Investigational Site
city: Lisbon
country: Portugal
facility: Pfizer Investigational Site
city: Ponta Delgada
country: Portugal
facility: Pfizer Investigational Site
city: Ponte de Lima
country: Portugal
facility: Pfizer Investigational Site
city: Ponte de Lima
country: Portugal
facility: Pfizer Investigational Site
city: Ekaterinburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Petrozavodsk
country: Russian Federation
facility: Pfizer Investigational Site
city: Smolensk
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Belgrade
country: Serbia
facility: Pfizer Investigational Site
city: Niska Banja
country: Serbia
facility: Pfizer Investigational Site
city: Novi Sad
country: Serbia
facility: Pfizer Investigational Site
city: Sinapore
country: Singapore
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
city: Bloemfontein
country: South Africa
facility: Pfizer Investigational Site
state: Free State
city: Johannesburg
country: South Africa
facility: Pfizer Investigational Site
state: Gauteng Province
city: Durban
country: South Africa
facility: Pfizer Investigational Site
state: KZN
city: Parow
country: South Africa
facility: Pfizer Investigational Site
state: Western Cape
city: Bellville
country: South Africa
facility: Pfizer Investigational Site
city: Cape Town
country: South Africa
facility: Pfizer Investigational Site
city: Kempton Park
country: South Africa
facility: Pfizer Investigational Site
city: Observatory Cape Town
country: South Africa
facility: Pfizer Investigational Site
city: Partida DE Bacarot
country: Spain
facility: Pfizer Investigational Site
state: Alicante
city: Oviedo
country: Spain
facility: Pfizer Investigational Site
state: Asturias
city: Sabadell
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Barakaldo
country: Spain
facility: Pfizer Investigational Site
state: Vizcaya
city: Avila
country: Spain
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Zaragoza
country: Spain
facility: Pfizer Investigational Site
city: Goteborg
country: Sweden
facility: Pfizer Investigational Site
city: Goteborg
country: Sweden
facility: Pfizer Investigational Site
city: Lulea
country: Sweden
facility: Pfizer Investigational Site
city: Norrkoping
country: Sweden
facility: Pfizer Investigational Site
city: Kaohsiung Hsien
country: Taiwan
facility: Pfizer Investigational Site
city: Taichung
country: Taiwan
facility: Pfizer Investigational Site
city: Tainan
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Tao-Yuan
country: Taiwan
facility: Pfizer Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: Pfizer Investigational Site
city: Donetsk
country: Ukraine
facility: Pfizer Investigational Site
city: Donetsk
country: Ukraine
facility: Pfizer Investigational Site
city: Ivano-Frankivsk
country: Ukraine
facility: Pfizer Investigational Site
city: Kharkiv
country: Ukraine
facility: Pfizer Investigational Site
city: Kharkiv
country: Ukraine
facility: Pfizer Investigational Site
city: Kharkiv
country: Ukraine
facility: Pfizer Investigational Site
city: Kharkiv
country: Ukraine
facility: Pfizer Investigational Site
city: Kiev
country: Ukraine
facility: Pfizer Investigational Site
city: Kyiv
country: Ukraine
facility: Pfizer Investigational Site
city: Lutsk
country: Ukraine
facility: Pfizer Investigational Site
city: Lviv
country: Ukraine
facility: Pfizer Investigational Site
city: Odessa
country: Ukraine
facility: Pfizer Investigational Site
city: Odessa
country: Ukraine
facility: Pfizer Investigational Site
city: Odessa
country: Ukraine
facility: Pfizer Investigational Site
city: Simferopol
country: Ukraine
facility: Pfizer Investigational Site
city: Zaporizhzhia
country: Ukraine
facility: Pfizer Investigational Site
city: Helensburgh
country: United Kingdom
facility: Pfizer Investigational Site
state: Argyle & Clyde
city: Maidenhead
country: United Kingdom
facility: Pfizer Investigational Site
state: Berks
city: Aston Clinton
country: United Kingdom
facility: Pfizer Investigational Site
state: Buckinghamshire
city: St Austell
country: United Kingdom
facility: Pfizer Investigational Site
state: Cornwall
city: Bexhill on Sea
country: United Kingdom
facility: Pfizer Investigational Site
state: East Sussex
city: Aldershot
country: United Kingdom
facility: Pfizer Investigational Site
state: Hampshire
city: Basingstoke
country: United Kingdom
facility: Pfizer Investigational Site
state: Hampshire
city: Odiham
country: United Kingdom
facility: Pfizer Investigational Site
state: Hampshire
city: Ashford
country: United Kingdom
facility: Pfizer Investigational Site
state: Middlesex
city: Harrow
country: United Kingdom
facility: Pfizer Investigational Site
state: Middlesex
city: Camberley
country: United Kingdom
facility: Pfizer Investigational Site
state: Surrey
city: East Horsley, Leatherhead
country: United Kingdom
facility: Pfizer Investigational Site
state: Surrey
city: Pound Hill, Crawley
country: United Kingdom
facility: Pfizer Investigational Site
state: WEST Sussex
city: Bradford-on-Avon
country: United Kingdom
facility: Pfizer Investigational Site
state: Wiltshire
city: Chippenham
country: United Kingdom
facility: Pfizer Investigational Site
state: Wiltshire
city: Upton
country: United Kingdom
facility: Pfizer Investigational Site
state: Wirral
city: Bexhill on Sea
country: United Kingdom
facility: Pfizer Investigational Site
city: Canterbury
country: United Kingdom
facility: Pfizer Investigational Site
city: Chesterfield
country: United Kingdom
facility: Pfizer Investigational Site
city: Glasgow
country: United Kingdom
facility: Pfizer Investigational Site
city: Peterborough
country: United Kingdom
facility: Pfizer Investigational Site
city: Peterborough
country: United Kingdom
facility: Pfizer Investigational Site
city: St Leonards on Sea
country: United Kingdom
facility: Pfizer Investigational Site
city: Swindon
country: United Kingdom
facility: Pfizer Investigational Site
city: Vale Of Glamorgan
country: United Kingdom
facility: Pfizer Investigational Site
city: Wansford
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.