CONDOR | GI-REASONS | |
---|---|---|
Study duration | 6 mo | 6 mo |
Study population | OA or RA subjects at high GI risk
| OA subjects of moderate GI risk
|
Population size | 4402 subjects | 8000 subjects |
Treatment arms |
|
|
Primary endpoint (adjudicated by GI events committee) | CSULGIE | CSULGIE including symptomatic ulcers |
Secondary endpoints |
|
|
Aspirin usage | No | No |
PPI usage | Yes: double-blind nonselective NSAID treatment arm prescribed concomitant omeprazole, as study medication | Yes: at discretion of investigator (open-label) |
Helicobacter pylori | Excluded | Included (stratified at baseline) |
OA: osteoarthritis; RA: rheumatoid arthritis; GI: gastrointestinal; GD: gastroduodenal; US PI: US prescribing information; NSAID: nonsteroidal antiinflammatory drug; CSULGIE: clinically significant upper and lower gastrointestinal events; Hgb: hemoglobin; Hct: hematocrit; AE: adverse event; PPI: proton-pump inhibitor.