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

This study is not yet open for patient recruitment.
Verified by Pfizer August 2005

Sponsored by: Pfizer
Information provided by: Pfizer 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
Arthritis, Rheumatoid
 Drug: Celecoxib
 Drug: Diclofenac plus Omeprazole
Phase IV

MedlinePlus related topics:  Osteoarthritis;   Rheumatoid Arthritis

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, 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

Further Study Details: 
Primary Outcomes: The primary endpoint of this study is the incidence of clinically significant upper and/or lower GI events (CSULGIEs). For the purposes of this trial CSULGIEs are considered any event that in clinical practice would impact the subject in terms of inpatie
Secondary Outcomes: The secondary endpoints of this study are:; The incidence of CSULGIEs plus symptomatic ulcers (SUs); The Patients Global Assessment of Arthritis; Change in Hb and Hct from Baseline to Visit 6; The incidence of subjects who have a clinically significant d
Expected Total Enrollment:  4400

Study start: October 2005


Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Inclusion Criteria:

Exclusion Criteria:

  • Active GD ulceration or GD ulceration within 90 days of the screening visit.
  • Concommitant use of low dose aspirin
  • Previous MI, stroke or significant vascular disease.

Location and Contact Information

Please refer to this study by identifier  NCT00141102

Study chairs or principal investigators

Pfizer Call Center,  Study Director,  Pfizer   

More Information

Study ID Numbers:  A3191084
Last Updated:  August 31, 2005
Record first received:  August 29, 2005 Identifier:  NCT00141102
Health Authority: United Kingdom: Department of Health processed this record on 2005-09-06


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