NCT00141102

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 4,484 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis
• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	Celecoxib	Participants are assigned to one of two groups in parallel for the duration of the study
DRUG	Diclofenac + Omeprazole	Participants are assigned to one of two groups in parallel for the duration of the study

Timeline

• Start date: 2005-10-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2005-09-01
• Last updated: 2021-03-03
• Results posted: 2010-06-11

Locations

194 sites across 32 countries: Belgium, Brazil, Canada, China, Colombia, Costa Rica, Croatia, Czechia, Ecuador, Estonia, France, Germany, Greece, Guatemala, Hong Kong, India, Latvia, Lithuania, Netherlands, Panama, Peru, Portugal, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, Ukraine, United Kingdom