Celecoxib: Phase IV data

In the double-blind, international Phase IV CONDOR trial in 4,484 patients, twice-daily 200 mg Celebrex met the composite primary endpoint of significantly reducing the incidence of upper or lower gastrointestinal events vs. 75 mg diclofenac plus 20 mg omeprazole over 6 months (0.9% vs. 3.8%, p<0.0001). Celebrex also significantly reduced the number of clinically significant events throughout the GI tract plus systemic ulcers vs. diclofenac plus omeprazole (1% vs. 5%, p<0.0001), but non-significantly improved Patient's Global Assessment of Arthritis from baseline (0.75 vs. 0.77, p=0.41). Additionally, Celebrex significantly reduced the number of patients with moderate-to-severe abdominal symptoms at 6 months (16% vs. 19%, p=0.03), and significantly fewer patients treated with Celebrex withdrew early due to GI adverse events vs. diclofenac plus omeprazole (114 vs. 167, p=0.0006). Data were published in The Lancet. ...