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

Phase 4

Completed

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

• Registration Number: NCT00633438
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Study Completion: 2004-06
• Study First Submitted: 2008-03-04
• Study First Submitted QC: 2008-03-04
• 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: 204

Inclusion Criteria

Inclusion criteria:

• Diagnosed (or suspected to have) meniscus trauma of the knee requiring ambulatory arthroscopic knee surgery
• Willing to participate in study for 36 hours and come to follow-up visit 7 days post surgery

Exclusion Criteria

Exclusion criteria:

• Osteoarthritis, inflammatory arthritis, or previous fracture of index joint
• Received acetaminophen or low dose narcotic (vicodin/tylox) within 8 hours of surgery
• Have received oral (4 weeks), intramuscular (2 months), intra-articular (3 months) or soft-tissue (2 months) injections of corticosteroids of the first dose of study medication or intra-artcular injections of hyaluronic acid in the index joint within 9 months of the first dose of study medication

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 (hydrocodone bitartrate 5 mg/acetaminophen 500 mg [HC/APAP]) after surgery	24 hours

Secondary Outcome Measures

Name	Time	Method
Physical exam	Day 7
Number and percentage of patients taking HC/APAP after surgery	1, 2, 6, 8, 10, 12, 24, 36 hours
Time to analgesic use after surgery	1, 2, 6, 8, 10, 12, 24, 36 hours
Patient Assessment of Pain, according to visual analogue scale, after surgery at rest and flexion	1, 2, 6, 8, 10, 12, 24, 36 hours
Adverse events	Day 7
Vital signs	Day 7
Laboratory evaluation	Day 7

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 San Antonio, Texas, United States