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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00141102 |
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.
Condition | Intervention | Phase |
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Osteoarthritis Arthritis, Rheumatoid |
Drug: Celecoxib Drug: Diclofenac + Omeprazole |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy 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 |
Estimated Enrollment: | 4400 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental |
Drug: Celecoxib
Participants are assigned to one of two groups in parallel for the duration of the study
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B: Active Comparator |
Drug: Diclofenac + Omeprazole
Participants are assigned to one of two groups in parallel for the duration of the study
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A3191084 |
Study First Received: | August 29, 2005 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00141102 |
Health Authority: | United Kingdom: Department of Health |
GI events in high risk GI arthritis patients |
Celecoxib Autoimmune Diseases Musculoskeletal Diseases Osteoarthritis Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Omeprazole Diclofenac Rheumatic Diseases |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Immune System Diseases Physiological Effects of Drugs Cyclooxygenase Inhibitors Gastrointestinal Agents Enzyme Inhibitors Pharmacologic Actions Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Anti-Ulcer Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |