The study was done to evaluate the pain relief and safety of 2 valdecoxib doses compared to placebo in patients with moderate or severe pain following bunionectomy surgery, and to evaluate the effect of the 2 valdecoxib doses compared to placebo on health outcome measures and on the occurrence of opioid related symptoms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
450
valdecoxib 40 mg tablet by mouth followed by a valdecoxib 20 mg tablet by mouth after 1 to 12 hours of the initial dose on Day 1 then a valdecoxib 20 mg tablet by mouth once daily on Days 2 through 5
valdecoxib 40 mg tablet by mouth followed by a valdecoxib 20 mg tablet by mouth after 1 to 12 hours of the initial dose on Day 1 then a valdecoxib 20 mg tablet by mouth twice daily on Days 2 through 5
valdecoxib 40 mg tablet by mouth followed by a valdecoxib 20 mg tablet by mouth after 1 to 12 hours of the initial dose on Day 1 then placebo on Days 2 through 5
Patient's Global Evaluation of Study Medication
Time frame: Day 2 and Day 3
Summed Pain Intensity (SPI) (categorical) through 24 hours
Time frame: Day 2 and Day 3
Health Outcomes Post-Discharge Recovery Experience
Time frame: Days 2 to 5
adverse events
Time frame: continuous
Time to first dose of rescue medication (rescue analgesic medication)
Time frame: Days 2 to 5
SPI 24 (categorical)
Time frame: Day 4 and Day 5
Time-specific Pain Intensity (PI) (categorical)
Time frame: Days 2 to 5
SPI 24 (Visual Analog Scale [VAS])
Time frame: Days 2 to 5
Time-specific PI (VAS)
Time frame: Days 2 to 5
Patient's Global Evaluation of Study Medication
Time frame: Day 4 and Day 5
Percent of patients who took rescue medication (rescue analgesic medication)
Time frame: Days 2 to 5
Worst Pain Intensity (derived from the Modified BPI-Short Form)
Time frame: Days 2 to 5
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Time between doses of study medication
Time frame: Days 2 to 5
Individual and Composite Pain Interference Score (derived from the modified BPI-Short Form)
Time frame: Days 2 to 5
Symptom Distress Questionnaire
Time frame: Days 2 to 5
Average Pain Intensity (derived from the Modified BPI-Short Form)
Time frame: Days 2 to 5
Amount of rescue medication (rescue analgesic medication) taken
Time frame: Days 2 to 5