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 enrollmentFebruary 2003

Overview

To compare the total analgesic use at 24 hours after arthroscopic knee surgery in patients treated with celecoxib versus placebo.

Registry

clinicaltrials.gov

Start Date

February 2003

End Date

August 2003

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Responsible Party

Sponsor

Intervention: Celecoxib

Intervention: Placebo

Total analgesic use after surgery

Time Frame: 24 hours

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)