Effect of Celecoxib Versus Placebo Before and After Knee Surgery on the Overall Use of Analgesics After Surgery
- Registration Number
- NCT00633386
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
To compare the total analgesic use at 24 hours after arthroscopic knee surgery in patients treated with celecoxib versus placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B Placebo - A Celecoxib -
- Primary Outcome Measures
Name Time Method Total analgesic use after surgery 24 hours
- Secondary Outcome Measures
Name Time Method Time to analgesic use after surgery 1, 2, 6, 8, 10, 12, 24, and 36 hours Physical examination Day 7 Cumulative number of HC/APAP tablets taken after first dose of study medication 1, 2, 6, 8, 10, 12, 36 hours and Day 2 Vital signs Day 7 Change in volumetric measurement of both knees from prior to surgery Day 7 Adverse events Day 7 Number and percentage of subjects taking analgesic (hydrocodone bitartrate 5 mg/acetaminophen 500 mg [HC/APAP]) after surgery 1, 2, 6, 8, 10, 12, 24, and 36 hours Patient's Assessment of Knee Pain, according to visual analogue scale at rest and with movement after surgery 1, 2, 6, 8, 10, 12, 24 and 36 hours Patient Treatment Satisfaction Scales after surgery 24 hours
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Charlottesville, Virginia, United States
Pfizer Investigational Site🇺🇸Charlottesville, Virginia, United States