To determine whether valdecoxib 40 mg twice a day the first day and then 40mg once a day until Day 7, was at least as effective as diclofenac 75 mg twice a day for 7 days, in treating acute first or second degree ankle sprain. The study also compared valdecoxib and diclofenac with respect to time to onset of pain relief (measured after the first dose), tolerability (adverse events) and time to return to Normal Function/Activity, among other measures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
202
valdecoxib 40 mg tablet by mouth twice daily (BID) on Day 1 and then once daily (QD) on Days 2 to 7
diclofenac 75 mg capsule by mouth twice daily (BID) for 7 days
Pfizer Investigational Site
Avellaneda, Buenos Aires, Argentina
Pfizer Investigational Site
San Isidro, Buenos Aires, Argentina
Pfizer Investigational Site
Buenos Aires, Argentina
Pfizer Investigational Site
Santiago, RM, Chile
Pfizer Investigational Site
Santiago, Chile
Pfizer Investigational Site
Medellín, Antioquia, Colombia
Pfizer Investigational Site
Bogota, Cundinamarca, Colombia
Pfizer Investigational Site
Bogota, Cundinamarca, Colombia
Pfizer Investigational Site
Bogotá, Cundinarmarca, Colombia
Pfizer Investigational Site
Bucaramanga, Santander Department, Colombia
...and 5 more locations
Patient's assessment of ankle pain VAS
Time frame: Day 4
Time to onset of pain relief
Time frame: 0, 15, 30, 45, and 60 minutes after first dose
Physician's global assessment of ankle injury
Time frame: Days 1, 4, and 7
Patient's global assessment of ankle injury
Time frame: Days 1, 4 and 7
Patient's assessment of normal function/activity
Time frame: Days 1 to 7
Patient's and physician's satisfaction assessments
Time frame: Day 7
Patient's assessment of ankle pain on visual analogue scale (VAS)
Time frame: Days 1 to 7
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