Celebrex Total Knee Arthroplasty Study - Tabular View

Tracking Information

First Received Date ^ICMJE

July 28, 2006

Last Updated Date

May 22, 2008

Start Date ^ICMJE

November 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

To assess the effects of celecoxib on the cumulative amount of opioid administered to OA subjects undergoing unilateral total knee arthroplasty. [ Time Frame: 19 July 2007 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

To assess the effects of celecoxib on the cumulative amount of opiod administered to OA subjects undergoing unilateral total knee arthroplasty.

Change History

Complete list of historical versions of study NCT00359151 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To assess the effects of celecoxib on pain and function during the peri-operative period and the post-operative rehabilitation phase. [ Time Frame: 19 July 2007 ] [ Designated as safety issue: No ]
To assess the safety and tolerability of celecoxib in this study population. [ Time Frame: 19 July 2007 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

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.

Descriptive Information

Brief Title ^ICMJE

Celebrex Total Knee Arthroplasty Study

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Osteoarthritis
Pain

Intervention ^ICMJE

Drug: Celecoxib
Drug: Placebo

Study Arms / Comparison Groups

Experimental: Celecoxib
Placebo Comparator: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

July 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00359151

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study ID Numbers ^ICMJE

A3191225

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP