To evaluate the analgesic efficacy, general safety, and effects on health outcome measures and opioid-related symptoms of 2 valdecoxib dosing regimens compared with placebo in patients with moderate or severe pain following laparoscopic cholecystectomy surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
490
valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, placebo twice daily (BID) on Days 2 to 5
valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, valdecoxib 20 mg once daily (QD)on Days 2 to 5.
valdecoxib 40 mg by mouth within 8 hours after the end of surgery, followed by a second dose of valdecoxib 20 mg within 1 to 12 hours (or by midnight on the Day 1, whichever was earlier); then, valdecoxib 20 mg twice daily (BID) on Days 2 to 5.
Patient's Global Evaluation of Study Medication
Time frame: Day 2 and Day 3
Summed Pain Intensity (categorical) through 24 hours (SPI 24)
Time frame: Day 2 and Day 3
Time-specific PI (VAS)
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
Time frame: Days 2 to 5
Percent of patients who took rescue medication on each study day
Time frame: Days 2 to 5
Amount of rescue medication taken
Time frame: Days 2 to 5
Time between doses of study medication
Time frame: Days 2 to 5
Worst PI (derived from the mBPI-SF)
Time frame: Days 2 to 5
Average PI (derived from the mBPI-SF)
Time frame: Days 2 to 5
SPI 24 (categorical)
Time frame: Day 4 and Day 5
Time-specific PI (categorical)
Time frame: Days 2 to 5
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SPI 24 (VAS)
Time frame: Days 2 to 5