Effect of Celecoxib Versus Placebo Before and After Knee Surgery on the 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: NCT00633386
• Other study ID #: A3191066
• Status: Completed
• Phase: Phase 4
• Start date: February 2003
• Est. completion date: August 2003

Study information

• Verified date: February 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion criteria:

• Diagnosed knee meniscus pathology requiring ambulatory arthroscopic meniscectomy or partial meniscectomy

• Willing to participate in study for 36 hours and come to follow-up visit 7 days post-surgery

Exclusion criteria:

• Osteoarthritis, inflammatory arthritis, or previous fracture of index joint

• Received acetaminophen or low-dose narcotic 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 received intra-articular injections of hyaluronic acid in the index joint within 9 months of the first dose of study medication

Related Conditions & MeSH terms

• Arthroscopy

Intervention

Drug:
• Celecoxib
400 mg oral capsule as a single dose 1 hour prior to surgery and 200 mg oral capsule as a single dose as needed post-surgery

Other:
• Placebo
Matched placebo

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Charlottesville	Virginia
United States	Pfizer Investigational Site	Columbia	South Carolina
United States	Pfizer Investigational Site	Johnson City	Tennessee
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	Springfield	Massachusetts
United States	Pfizer Investigational Site	Springfield	Missouri

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 after surgery		24 hours
Secondary	Physical examination		Day 7
Secondary	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
Secondary	Time to analgesic use after surgery		1, 2, 6, 8, 10, 12, 24, and 36 hours
Secondary	Cumulative number of HC/APAP tablets taken after first dose of study medication		1, 2, 6, 8, 10, 12, 36 hours and Day 2
Secondary	Vital signs		Day 7
Secondary	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
Secondary	Change in volumetric measurement of both knees from prior to surgery		Day 7
Secondary	Patient Treatment Satisfaction Scales after surgery		24 hours
Secondary	Adverse events		Day 7

External Links

•   To obtain contact information for a study center near you, click here.