To demonstrate non-inferiority of valdecoxib 20 mg twice daily (BID) (with an initial loading dose of 40 mg followed by a second dose of 20 mg on the first day only) with diclofenac sodium delayed release 75 mg BID in analgesic efficacy, in subjects undergoing knee arthroscopy procedure for anterior cruciate ligament (ACL) reconstruction, when administered for 6 (±1) days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
328
valdecoxib 40 mg (two 20-mg tablets) loading dose by mouth on Day 1 followed by 20 mg twice daily (BID) on Days 2-6
diclofenac sodium delayed release tablets 75 mg by mouth twice daily (BID) for 6 days
Pfizer Investigational Site
Adelaide, South Australia, Australia
Pfizer Investigational Site
Hong Kong, Hong Kong
Pfizer Investigational Site
Shatin, New Territories, Hong Kong
Pfizer Investigational Site
Cheras, Kuala Lumpur, Malaysia
Pfizer Investigational Site
Kuala Lumpur, Kuala Lumpur, Malaysia
Pfizer Investigational Site
Kuala Lumpur, Kuala Lumpur, Malaysia
Pfizer Investigational Site
Auckland, New Zealand
Pfizer Investigational Site
Christchurch, New Zealand
Pfizer Investigational Site
Wellington, New Zealand
Pfizer Investigational Site
Manila, Philippines
...and 15 more locations
Patient Assessment of Pain - Visual Analogue Scale
Time frame: Days 1-6
Physical examination
Time frame: Screening and Day 6
Global Evaluation of Study Medication
Time frame: Days 1-6
Consumption of Rescue Medication
Time frame: Days 1-6
Modified Brief Pain Inventory - short form
Time frame: Days 2-6
Adverse events
Time frame: Days 1-6
Vital signs
Time frame: Screening, Day 1, and Day 6
Effect on Pain Medication Questionnaire and Health Resource Utilization
Time frame: Days 2-6
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