Status:
COMPLETED
Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With Arthritis
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Osteoarthritis
Arthritis, Rheumatoid
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
4484 Patients enrolled
Trial Details
Trial ID
NCT00141102
Start Date
October 1 2005
End Date
May 1 2009
Last Update
March 3 2021
Active Locations (194)
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1
Pfizer Investigational Site
Genk, Belgium, 3600
2
Pfizer Investigational Site
Ghent, Belgium, 9000
3
Pfizer Investigational Site
Hasselt, Belgium, 3500
4
Pfizer Investigational Site
Liège, Belgium, 4000