Effect of Celecoxib Versus Placebo Before and After Knee Surgery on the Overall Use of Analgesics After Surgery

Phase 4

Completed

• Conditions: Arthroscopy
• Interventions: Other: Placebo; Drug: Celecoxib

• 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

Study Timeline

• Study Start: 2003-02
• Study Completion: 2003-08
• Study First Submitted: 2008-03-04
• Study First Submitted QC: 2008-03-11
• Study First Posted: 2008-03-12
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21

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