CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 4,484 enrolled
Drug / intervention
Celecoxib +1 moredrug
Likely dose
Celecoxib 200 mg twice daily or diclofenac SR 75 mg twice daily plus omeprazole 20 mg once dailyAI-extracted
Key inclusion· 2
  • ✓Clinical diagnosis of osteoarthritis or rheumatoid arthritis requiring regular anti-inflammatory therapy
  • ✓Age ≥60 years (with or without history of gastroduodenal ulceration) OR any age ≥18 with documented gastroduodenal ulceration ≥90 days prior to screening
Key exclusion· 3
  • ✕Active gastroduodenal ulceration or ulceration within 90 days of screening visit
  • ✕Concomitant use of low-dose aspirin
  • ✕History of myocardial infarction, stroke, or significant vascular disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00141102
NCT00141102Phase 4Completed
CompareCT.gov

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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Sep 1, 2005·Updated Mar 3, 2021

In Brief

A Phase 4 clinical trial evaluating Celecoxib and Diclofenac + Omeprazole for Osteoarthritis and Arthritis, Rheumatoid. Completed, enrolled 4,484 participants across 194 sites in 32 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis, Arthritis, Rheumatoid
CountriesBelgium, 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
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 1, 2005
Enrollment StartOct 1, 2005
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 20.8 years ago

Interventions

Celecoxibdrug

Participants are assigned to one of two groups in parallel for the duration of the study

Diclofenac + Omeprazoledrug

Participants are assigned to one of two groups in parallel for the duration of the study