The primary objective was to evaluate the analgesic efficacy of valdecoxib 20 mg daily and valdecoxib 20 mg twice daily compared with placebo in outpatients with moderate-severe pain after arthroscopic anterior cruciate ligament (ACL) reconstruction surgery. Secondary objectives were to compare each valdecoxib dose with placebo on additional measures of pain intensity, health outcomes, the use of rescue medication, and the occurrence of opioid-related symptoms, and to evaluate their safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
488
valdecoxib 40 mg (two 20-mg tablets) by mouth followed by valdecoxib 20 mg 1 to 12 hours after the first dose or 12 hours after the first dose, but no later than midnight on Day 1; then, placebo BID by mouth on Days 2 to 5.
valdecoxib 40 mg (two 20-mg tablets) by mouth followed by valdecoxib 20 mg 1 to 12 hours after the first dose or 12 hours after the first dose, but no later than midnight on Day 1; then, valdecoxib 20 mg once daily (QD) by mouth on Days 2 to 5.
valdecoxib 40 mg (two 20-mg tablets) by mouth followed by valdecoxib 20 mg 1 to 12 hours after the first dose or 12 hours after the first dose, but no later than midnight on Day 1; then, valdecoxib 20 mg twice daily (BID) by mouth on Days 2 to 5.
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Northport, Alabama, United States
Pfizer Investigational Site
Glendale, Arizona, United States
Pfizer Investigational Site
Pheonix, Arizona, United States
Summed Pain Intensity (categorical) through 24 hours (SPI 24)
Time frame: Day 2 and Day 3
Patient's Global Evaluation of Study Medication (PGESM)
Time frame: Day 2 and Day 3
Average Pain Intensity (derived from the mBPI-sf) on each study day
Time frame: Days 2 to 5
Worst Pain Intensity (derived from the Modified Brief Pain Inventory Short Form [mBPI-sf]) on each study day
Time frame: Days 2 to 5
Symptom Distress Scale Questionnaire
Time frame: Days 2 to 5
Patient Satisfaction Questionnaire for each study day
Time frame: Days 2 to 5
Time-specific pain intensity (PI) (categorical) on each study day
Time frame: Days 2 to 5
SPI 24 (Visual Analog Scale [VAS]) on each study day
Time frame: Days 2 to 5
Time-specific PI (VAS) on each study day
Time frame: Days 2 to 5
Patient's Global Evaluation of Study Medication
Time frame: Day 4 and Day 5
Time to first dose of rescue medication (supplemental analgesia) on each study day
Time frame: Days 2 to 5
Percent of subjects who took rescue medication (supplemental analgesia) on each study day
Time frame: Days 2 to 5
Amount of rescue medication (supplemental analgesia) taken on each study day
Time frame: Days 2 to 5
Individual and Composite Pain Interference With Function score (derived from the mBPI-sf) on each day
Time frame: Days 2 to 5
Time between doses of study medication on each study day
Time frame: Days 2 to 5
Post-Discharge Recovery Experience for each study day
Time frame: Days 2 to 5
SPI 24 (categorical)
Time frame: Day 4 and Day 5
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Pfizer Investigational Site
Pheonix, Arizona, United States
Pfizer Investigational Site
Pheonix, Arizona, United States
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Tempe, Arizona, United States
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