Back to resultsStudy Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis (CONDOR)
Primary Purpose
Osteoarthritis, Arthritis, Rheumatoid
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Celecoxib
Diclofenac + Omeprazole
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring GI events in high risk GI arthritis patients
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.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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".
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.
Change From Baseline in Hemoglobin at Month 6/ET
Change From Baseline in Hematocrit at 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.
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.
Change From Baseline in Hepatic Measures of GGT, AST or ALT to Month 6/ET
Change From Baseline in Iron Binding Capacity to Month 6/ET
Change From Baseline in Ferretin to Month 6/ET
Change From Baseline in C-Reactive Protein to Month 6/ET
Full Information
NCT ID
NCT00141102
First Posted
August 29, 2005
Last Updated
March 1, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00141102
Brief Title
Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Arthritis, Rheumatoid
Keywords
GI events in high risk GI arthritis patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
4484 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Intervention Description
Participants are assigned to one of two groups in parallel for the duration of the study
Intervention Type
Drug
Intervention Name(s)
Diclofenac + Omeprazole
Intervention Description
Participants are assigned to one of two groups in parallel for the duration of the study
Primary Outcome Measure Information:
Title
Number of Subjects With Clinically Significant Upper and/or Lower Gastrointestinal Events (CSULGIEs)
Description
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.
Time Frame
6 month treatment duration
Secondary Outcome Measure Information:
Title
Number of Subjects With CSULGIES or Symptomatic Ulcers (SUs)
Description
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.
Time Frame
6 month treatment duration
Title
Change From Baseline in Patient's Global Arthritis Assessment at Month 6/Early Termination (ET)
Description
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.
Time Frame
Month 6/Early Termination (ET)
Title
Number of Subjects With SUs
Description
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.
Time Frame
6 month treatment duration
Title
Number of Subjects With CSULGIEs by History of GD Ulceration
Description
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.
Time Frame
6 month treatment duration
Title
Number of Subjects With Moderate to Severe Abdominal Symptoms
Description
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".
Time Frame
6 month treatment duration
Title
Number of Subjects Withdrawn Due to GI Adverse Events (AEs)
Description
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.
Time Frame
6 month treatment duration
Title
Change From Baseline in Hemoglobin at Month 6/ET
Time Frame
Month 6/ET
Title
Change From Baseline in Hematocrit at Month 6/ET
Time Frame
Month 6/ET
Title
Number of Subjects With a Clinically Significant Decrease From Baseline in Hematocrit and/or Hemoglobin
Description
A clinically significant decrease from baseline was defined as a fall in hematocrit > = 10 percentage points and/or hemoglobin > = 2 g/dL.
Time Frame
6 month treatment duration
Title
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)
Description
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.
Time Frame
6 month treatment duration
Title
Change From Baseline in Hepatic Measures of GGT, AST or ALT to Month 6/ET
Time Frame
Month 6/ET
Title
Change From Baseline in Iron Binding Capacity to Month 6/ET
Time Frame
Month 6/ET
Title
Change From Baseline in Ferretin to Month 6/ET
Time Frame
Month 6/ET
Title
Change From Baseline in C-Reactive Protein to Month 6/ET
Time Frame
Month 6/ET
Other Pre-specified Outcome Measures:
Title
Number of Subjects Alive at the Post Trial Interview
Description
Interview occurred via telephone to obtain follow-up mortality and hospitalization information.
Time Frame
6 months following last dose
Title
Number of Subjects Hospitalized in Last 6 Months at the Post Trial Interview
Description
Interview occurred via telephone to obtain follow-up mortality and hospitalization information.
Time Frame
6 months following last dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Goiânia
State/Province
GO
ZIP/Postal Code
74043-110
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Goiânia
State/Province
GO
ZIP/Postal Code
74110-120
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Curitiba
State/Province
PR
ZIP/Postal Code
80060-240
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Curitiba
State/Province
PR
ZIP/Postal Code
80060-900
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
22271-100
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04230-000
Country
Brazil
Facility Name
Pfizer Investigational Site
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403-010
Country
Brazil
Facility Name
Pfizer Investigational Site
City
São Paulo
State/Province
SP
ZIP/Postal Code
05437-010
Country
Brazil
Facility Name
Pfizer Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M3
Country
Canada
Facility Name
Pfizer Investigational Site
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3E1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1Y2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 3R7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 5A6
Country
Canada
Facility Name
Pfizer Investigational Site
City
Pointe Claire
State/Province
Quebec
ZIP/Postal Code
H9R 3J1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Ste Foy
State/Province
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada
Facility Name
Pfizer Investigational Site
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Facility Name
Pfizer Investigational Site
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Facility Name
Pfizer Investigational Site
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Pfizer Investigational Site
City
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
Pfizer Investigational Site
City
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Pfizer Investigational Site
City
Beijing
ZIP/Postal Code
100073
Country
China
Facility Name
Pfizer Investigational Site
City
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Pfizer Investigational Site
City
Shanghai
ZIP/Postal Code
200001
Country
China
Facility Name
Pfizer Investigational Site
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Pfizer Investigational Site
City
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Pfizer Investigational Site
City
Tianjin
ZIP/Postal Code
300192
Country
China
Facility Name
Pfizer Investigational Site
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
0
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
0
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Barranquilla
State/Province
Atlantico
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Bogota
State/Province
Cundinamarca
ZIP/Postal Code
0
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Floridablanca
State/Province
Santander
ZIP/Postal Code
0
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Cartago
Country
Costa Rica
Facility Name
Pfizer Investigational Site
City
Heredia
Country
Costa Rica
Facility Name
Pfizer Investigational Site
City
San Jose
ZIP/Postal Code
3er piso.
Country
Costa Rica
Facility Name
Pfizer Investigational Site
City
San Jose
Country
Costa Rica
Facility Name
Pfizer Investigational Site
City
Opatija
ZIP/Postal Code
51410
Country
Croatia
Facility Name
Pfizer Investigational Site
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Pfizer Investigational Site
City
Plzen
State/Province
Bory
ZIP/Postal Code
30599
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Ostrava
State/Province
Trebovice
ZIP/Postal Code
722 00
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Ceske Budejovice
ZIP/Postal Code
370 01
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Hradec Kralove
ZIP/Postal Code
50012
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Prague 1
ZIP/Postal Code
118 00
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Praha 2
ZIP/Postal Code
120 00
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Praha 2
ZIP/Postal Code
128 50
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Praha 4
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Praha 6
ZIP/Postal Code
16900
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Cuenca
State/Province
Azuay
Country
Ecuador
Facility Name
Pfizer Investigational Site
City
Guayaquil
State/Province
Guayas
Country
Ecuador
Facility Name
Pfizer Investigational Site
City
Quito
State/Province
Pichincha
Country
Ecuador
Facility Name
Pfizer Investigational Site
City
Tallinn
ZIP/Postal Code
11312
Country
Estonia
Facility Name
Pfizer Investigational Site
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Pfizer Investigational Site
City
Tartu
ZIP/Postal Code
51007
Country
Estonia
Facility Name
Pfizer Investigational Site
City
Amiens
ZIP/Postal Code
80030
Country
France
Facility Name
Pfizer Investigational Site
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
12247
Country
Germany
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Pfizer Investigational Site
City
Deggingen
ZIP/Postal Code
73326
Country
Germany
Facility Name
Pfizer Investigational Site
City
Dresden
ZIP/Postal Code
01129
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hamburg
ZIP/Postal Code
22143
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hamburg
ZIP/Postal Code
22415
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hoyerswerda
ZIP/Postal Code
02977
Country
Germany
Facility Name
Pfizer Investigational Site
City
Kuenzing
ZIP/Postal Code
94550
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muenchen
ZIP/Postal Code
80639
Country
Germany
Facility Name
Pfizer Investigational Site
City
Nuernberg
ZIP/Postal Code
90402
Country
Germany
Facility Name
Pfizer Investigational Site
City
Thessaloniki
ZIP/Postal Code
54 636
Country
Greece
Facility Name
Pfizer Investigational Site
City
Ciudad de Guatemala
Country
Guatemala
Facility Name
Pfizer Investigational Site
City
Guatemala 01010
Country
Guatemala
Facility Name
Pfizer Investigational Site
City
Lai Chi Kok
Country
Hong Kong
Facility Name
Pfizer Investigational Site
City
Shatin
Country
Hong Kong
Facility Name
Pfizer Investigational Site
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500 033
Country
India
Facility Name
Pfizer Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 034
Country
India
Facility Name
Pfizer Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 079
Country
India
Facility Name
Pfizer Investigational Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560054
Country
India
Facility Name
Pfizer Investigational Site
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141 001
Country
India
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
133-792
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
137-040
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Riga
ZIP/Postal Code
LV 1002
Country
Latvia
Facility Name
Pfizer Investigational Site
City
Riga
ZIP/Postal Code
LV 1006
Country
Latvia
Facility Name
Pfizer Investigational Site
City
Riga
ZIP/Postal Code
LV 1038
Country
Latvia
Facility Name
Pfizer Investigational Site
City
Alytus
ZIP/Postal Code
LT-62114
Country
Lithuania
Facility Name
Pfizer Investigational Site
City
Kaunas
ZIP/Postal Code
LT-47144
Country
Lithuania
Facility Name
Pfizer Investigational Site
City
Kaunas
ZIP/Postal Code
LT-50425
Country
Lithuania
Facility Name
Pfizer Investigational Site
City
Klaipeda
ZIP/Postal Code
LT-94231
Country
Lithuania
Facility Name
Pfizer Investigational Site
City
Vilnius
ZIP/Postal Code
LT-07156
Country
Lithuania
Facility Name
Pfizer Investigational Site
City
Vlaardingen
State/Province
ZH
ZIP/Postal Code
3136 LA
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Alkmaar
ZIP/Postal Code
1815 JD
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Leidschendam
ZIP/Postal Code
2262 BA
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Ciudad de Panama
Country
Panama
Facility Name
Pfizer Investigational Site
City
Surco
State/Province
Lima
ZIP/Postal Code
Lima 33
Country
Peru
Facility Name
Pfizer Investigational Site
City
Lima
ZIP/Postal Code
27
Country
Peru
Facility Name
Pfizer Investigational Site
City
Lima
ZIP/Postal Code
L11
Country
Peru
Facility Name
Pfizer Investigational Site
City
Lima
ZIP/Postal Code
Lima 27
Country
Peru
Facility Name
Pfizer Investigational Site
City
Lima
ZIP/Postal Code
Lima 29
Country
Peru
Facility Name
Pfizer Investigational Site
City
Lisboa
ZIP/Postal Code
1249-075
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Lisboa
ZIP/Postal Code
1600-035
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Lisbon
ZIP/Postal Code
1000-247
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Ponta Delgada
ZIP/Postal Code
9500-370
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Ponte de Lima
ZIP/Postal Code
4990-049
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Ponte de Lima
ZIP/Postal Code
4990-49
Country
Portugal
Facility Name
Pfizer Investigational Site
City
Ekaterinburg
ZIP/Postal Code
620043
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
109004
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
109240
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
109388
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
113093
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
118089
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
St. Petersburg
ZIP/Postal Code
190000
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Pfizer Investigational Site
City
Niska Banja
ZIP/Postal Code
18205
Country
Serbia
Facility Name
Pfizer Investigational Site
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Pfizer Investigational Site
City
Sinapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Pfizer Investigational Site
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Pfizer Investigational Site
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
Facility Name
Pfizer Investigational Site
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9310
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Johannesburg
State/Province
Gauteng Province
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Durban
State/Province
KZN
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Parow
State/Province
Western Cape
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Bellville
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Cape Town
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Kempton Park
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Observatory Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Partida DE Bacarot
State/Province
Alicante
ZIP/Postal Code
03114
Country
Spain
Facility Name
Pfizer Investigational Site
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33006
Country
Spain
Facility Name
Pfizer Investigational Site
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barakaldo
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Name
Pfizer Investigational Site
City
Avila
ZIP/Postal Code
05004
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Pfizer Investigational Site
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Pfizer Investigational Site
City
Goteborg
ZIP/Postal Code
400 10
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Goteborg
ZIP/Postal Code
400 14
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Lulea
ZIP/Postal Code
972 33
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Norrkoping
ZIP/Postal Code
602 32
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Kaohsiung Hsien
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Tainan
ZIP/Postal Code
407
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Tao-Yuan
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Dnipropetrovsk
ZIP/Postal Code
49008
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Donetsk
ZIP/Postal Code
83003
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Donetsk
ZIP/Postal Code
83114
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Kharkiv
ZIP/Postal Code
61002
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Kharkiv
ZIP/Postal Code
61018
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Kharkiv
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Kharkiv
ZIP/Postal Code
61178
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Kiev
ZIP/Postal Code
01103
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Kyiv
ZIP/Postal Code
04053
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Lutsk
ZIP/Postal Code
43024
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Lviv
ZIP/Postal Code
79013
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Odessa
ZIP/Postal Code
65009
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Odessa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Odessa
ZIP/Postal Code
65026
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Simferopol
ZIP/Postal Code
95017
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Zaporizhzhia
ZIP/Postal Code
69118
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Helensburgh
State/Province
Argyle & Clyde
ZIP/Postal Code
G84 7QL
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Maidenhead
State/Province
Berks
ZIP/Postal Code
SL6 6EL
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Aston Clinton
State/Province
Buckinghamshire
ZIP/Postal Code
HP22 5LB
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
St Austell
State/Province
Cornwall
ZIP/Postal Code
PL26 7RL
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bexhill on Sea
State/Province
East Sussex
ZIP/Postal Code
TN39 4SP
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Aldershot
State/Province
Hampshire
ZIP/Postal Code
GU12 5BA
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Basingstoke
State/Province
Hampshire
ZIP/Postal Code
RG22 4EH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Odiham
State/Province
Hampshire
ZIP/Postal Code
RG29 1JY
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Ashford
State/Province
Middlesex
ZIP/Postal Code
TW15 3EA
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Harrow
State/Province
Middlesex
ZIP/Postal Code
HA3 7LT
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Camberley
State/Province
Surrey
ZIP/Postal Code
GU15 2NN
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
East Horsley, Leatherhead
State/Province
Surrey
ZIP/Postal Code
KT24 6QT
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Pound Hill, Crawley
State/Province
WEST Sussex
ZIP/Postal Code
RH10 7DX
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bradford-on-Avon
State/Province
Wiltshire
ZIP/Postal Code
BA1 5DQ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Chippenham
State/Province
Wiltshire
ZIP/Postal Code
SN14 6GT
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Upton
State/Province
Wirral
ZIP/Postal Code
L49 5PE
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bexhill on Sea
ZIP/Postal Code
TN39 5HE
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Canterbury
ZIP/Postal Code
CT1 3HX
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Chesterfield
ZIP/Postal Code
S40 4TF
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Glasgow
ZIP/Postal Code
G42 7AF
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Peterborough
ZIP/Postal Code
PE2 5GP
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Peterborough
ZIP/Postal Code
PE7 3JL
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
St Leonards on Sea
ZIP/Postal Code
TN37 6BG
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Swindon
ZIP/Postal Code
SN25 4YZ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Vale Of Glamorgan
ZIP/Postal Code
CF62 7EB
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Wansford
ZIP/Postal Code
PE8 6PL
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
24358067
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.
Results Reference
derived
PubMed Identifier
20638563
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. Erratum In: Lancet. 2011 Jul 16;378(9787):228.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3191084&StudyName=Study%20Of%20Celecoxib%20Or%20Diclofenac%20And%20Omeprazole%20For%20Gastrointestinal%20%28GI%29%20Safety%20In%20High%20GI%20Risk%20Patients%20With%20Arthritis
Description
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Learn more about this trial
Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis
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