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NCT00633438 Clinical Trial

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

Arthroscopy Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00633438
Other study ID # A3191067
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 2004
Est. completion date June 2004

Study information
Verified date February 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 204
Est. completion date June 2004
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Placebo
Matched oral capsule administered 1 hour prior to surgery and matched oral capsule administered post surgery as needed
Drug:
• Celecoxib
400 mg oral capsule as single dose administered 1 hour prior to surgery and 200 mg oral capsule as single dose administered post surgery as needed

Locations
Country Name City State
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Columbia South Carolina
United States Pfizer Investigational Site Columbia South Carolina
United States Pfizer Investigational Site Columbia South Carolina
United States Pfizer Investigational Site Johnson City Tennessee
United States Pfizer Investigational Site Orangeburg South Carolina
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Saint Petersburg Florida
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site Springfield Massachusetts
United States Pfizer Investigational Site Springfield Massachusetts
United States Pfizer Investigational Site Springfield Massachusetts
United States Pfizer Investigational Site Springfield Massachusetts
United States Pfizer Investigational Site Springfield Missouri
United States Pfizer Investigational Site Timonium Maryland

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Total analgesic use (hydrocodone bitartrate 5 mg/acetaminophen 500 mg [HC/APAP]) after surgery 24 hours
Secondary Patient Assessment of Pain, according to visual analogue scale, after surgery at rest and flexion 1, 2, 6, 8, 10, 12, 24, 36 hours
Secondary Time to analgesic use after surgery 1, 2, 6, 8, 10, 12, 24, 36 hours
Secondary Number and percentage of patients taking HC/APAP after surgery 1, 2, 6, 8, 10, 12, 24, 36 hours
Secondary Adverse events Day 7
Secondary Physical exam Day 7
Secondary Vital signs Day 7
Secondary Laboratory evaluation Day 7
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Enrolling by invitation NCT01052233 - Development of Knee Osteoarthritis After Arthroscopic Partial Resection of Degenerative Meniscus Tear Phase 4
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Not yet recruiting NCT03327337 - Arthroscopic Assisted Balloon Tibioplasty for the Treatment of Schatzker II-IV Tibial Plateau Fractures N/A
Completed NCT00633386 - Effect of Celecoxib Versus Placebo Before and After Knee Surgery on the Overall Use of Analgesics After Surgery Phase 4
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Completed NCT05165836 - Dexmedetomidine as Adjuvant in Erector Spinae Plane Block After Shoulder Arthroscopy N/A
Recruiting NCT06208774 - Pericapsular Nerve Group Block vs Interscalene Block for Shoulder Arthroscopy N/A
Recruiting NCT05646654 - Interscalene Block Versus Erector Spinae Plane Block for Shoulder Arthroscopy Anesthesia N/A
Active, not recruiting NCT04178538 - The Effect of Fertilized ACL Technique on Outcomes of ACL Reconstruction in Young Adults N/A

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