To assess the analgesic efficacy and general safety of 2 dosing regimens of valdecoxib compared to placebo on the first post-operative day in patients with moderate or severe pain following bunionectomy surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
360
valdecoxib 40 mg tablet by mouth within 6 hours of surgery followed by valdecoxib 20 mg tablet by mouth 1 to 12 hours after the first dose
valdecoxib 40 mg tablet by mouth within 6 hours of surgery followed by placebo 1 to 12 hours after the first dose
placebo within 6 hours of surgery followed by placebo 1 to 12 hours after the first dose
Pfizer Investigational Site
Phoenix, Arizona, United States
Summed Pain Intensity Difference (categorical) through 24 hours (SPID 24)
Time frame: Day 1
Total Pain Relief through 24 hours (TOTPAR 24)
Time frame: Day 1
Patient's Global Evaluation of Study Medication
Time frame: Day 1
time between doses of study medication
Time frame: Day 1
Time-specific Pain Intensity Difference (PID) (categorical)
Time frame: 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours
time-specific pain relief
Time frame: 2, 4, 6, 8, 10, 12, 16, and 24 hours
time-specific PID (VAS)
Time frame: 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours
Summed Pain Intensity (SPID)24 (VAS)
Time frame: 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours
time to rescue medication
Time frame: 2, 4, 6, 8, 10, 12, 16, and 24 hours
percent of patients who took rescue medication
Time frame: Day 1
Patient's Satisfaction Questionnaire
Time frame: Day 1
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Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Tempe, Arizona, United States
Pfizer Investigational Site
Anaheim, California, United States
Pfizer Investigational Site
Chula Vista, California, United States
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
Santa Ana, California, United States
Pfizer Investigational Site
Tustin, California, United States
...and 11 more locations