NCT00633386CompletedPhase 4
A Double-blind, Placebo-Controlled, Randomized, Comparison Study of the Efficacy of Celebrex 400 mg Single Dose Pre and Celebrex 200 mg Post Ambulatory Arthroscopic Knee Surgery for Total Analgesic Use After Surgery
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 site in 1 country200 target enrollmentStarted: February 2003Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Total analgesic use after surgery
Study Overview
Brief Summary
To compare the total analgesic use at 24 hours after arthroscopic knee surgery in patients treated with celecoxib versus placebo.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
A
Experimental
Intervention: Celecoxib (Drug)
B
Placebo Comparator
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Total analgesic use after surgery
Time Frame: 24 hours
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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