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Celebrex Total Knee Arthroplasty Study

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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, Englewood, Colorado 80110, United States

Pfizer Investigational Site, E, Colorado 80113, 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
Last updated: May 22, 2008

Page last updated: August 20, 2015

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