Valdure Clinical Trials and Studies
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Valdure Clinical Trials and Studies
The efficacy and clinical utility of Bextra Tablets have been demonstrated in osteoarthritis (OA),rheumatoid arthritis (RA) and in the treatment of primary dysmenorrhea.
Osteoarthritis
Bextra was evaluated for treatment of the signs and symptoms of osteoarthritis of the knee or hip,in five double-blind,randomized, controlled trials in which 3918 patients were treated for 3 to 6 months. Bextra was shown to be superior to placebo in improvement in three domains of OA symptoms:(1) the WOMAC (Western Ontario and McMaster Universities) osteoarthritis index,a composite of pain, stiffness and functional measures in OA,(2) the overall patient assessment of pain,and (3) the overall patient global assess-ment.The two 3-month pivotal trials in OA generally showed changes statistically significantly different from placebo,and comparable to the naproxen control,in measures of these domains for the 10 mg/day dose. No additional benefit from Bextra was seen with a valde-coxib 20-mg daily dose.
Rheumatoid Arthritis
Bextra demonstrated significant reduction compared to placebo in the signs and symptoms of RA,as measured by the ACR (American College of Rheumatology) 20 improvement, a composite defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five: patient global,physician global,patient pain,patient function assessment, and C-reactive protein (CRP). Bextra was evaluated for treatment of the signs and symptoms of rheumatoid arthritis in four double-blind, randomized, controlled studies in which 3444 patients were treated for 3 to 6 months. The two 3-month pivotal trials compared valdecoxib to naproxen and placebo. Trials of BEXTRA in rheumatoid arthritis allowed concomitant use of corticosteroids and/or disease-modifying anti-rheumatic drugs (DMARDs), such as methotrexate, gold salts, and hydroxychloroquine. No additional benefit was seen with a Bextra (valdecoxib) 20-mg daily dose.
Primary Dysmenorrhea
Bextra was compared to naproxen sodium 550 mg in two placebo-controlled studies of women with moderate to severe primary dys-menorrhea. The onset of analgesia was within 60 minutes for Bextra 20 mg. The onset, magnitude, and duration of analgesic effect with Bextra 20 mg were comparable to naproxen sodium 550mg.
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