Celebrex Total Knee Arthroplasty Study
Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis; Pain
Intervention: Celecoxib (Drug); Placebo (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
This study will investigate the benefits of administering celecoxib (Celebrex), a selective
cyclooxygenase - 2 (COX-2) inhibitor, in treating osteoarthritis (OA) subjects undergoing
elective unilateral primary total knee arthroplasty (TKA) from the pre-operative phase to the
management of post total knee replacement pain, and through the 6 weeks of physical therapy
and rehabilitation.
Clinical Details
Official title: Multicenter, Double Blind, Randomized, Placebo Controlled Trial Of The Efficacy And Safety Of Usual Care Plus Celecoxib Compared To Placebo For Peri-Operative And Rehabilitation Pain Control And Return To Function In Osteoarthritis Patients Undergoing Total Knee Arthroplasty
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Primary outcome: To assess the effects of celecoxib on the cumulative amount of opioid administered to OA subjects undergoing unilateral total knee arthroplasty.
Secondary outcome: To assess the effects of celecoxib on pain and function during the peri-operative period and the post-operative rehabilitation phase.To assess the safety and tolerability of celecoxib in this study population.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- The subject is a male or female 18 years or older with osteoarthritis of the knee
scheduled to undergo elective unilateral primary total knee arthroplasty because of
OA, performed under a standardized regimen of anesthesia and procedure.
Exclusion Criteria:
- Subject has a history of inflammatory arthritis (e. g. rheumatoid arthritis, ankylosing
spondylitis) other than osteoarthritis.
Locations and Contacts
Pfizer Investigational Site, Aurora, Colorado 80012, United States
Pfizer Investigational Site, E, Colorado 80113, United States
Pfizer Investigational Site, Englewood, Colorado 80110, United States
Pfizer Investigational Site, Chicago, Illinois 60612, United States
Pfizer Investigational Site, Philadelphia, Pennsylvania 19107, United States
Pfizer Investigational Site, Philadelphia, Pennsylvania 19140, United States
Pfizer Investigational Site, Bellaire, Texas 77410, United States
Pfizer Investigational Site, Houston, Texas 77030, United States
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: November 2006
Ending date: July 2007
Last updated: May 22, 2008
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