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Celebrex Total Knee Arthroplasty Study

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NCT00359151

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Aurora, Colorado, 80012 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis, Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Subject has a history of inflammatory arthritis (e.g. rheumatoid arthritis, ankylosing
spondylitis) other than osteoarthritis.

NCT00359151
Pfizer
Terminated
Celebrex Total Knee Arthroplasty Study

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Pfizer Clinical Trials Contact Center

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[email protected]

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Celebrex Total Knee Arthroplasty Study
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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Osteoarthritis
  • Pain
  • Drug: Celecoxib
    7 days pre-surgery (excluding day of surgery): 1 celecoxib 200 mg capsule or matching placebo QD; Day of surgery: 2 celecoxib 200 mg capsules or matching placebo within 2 hours prior to surgery, and 1 celecoxib 200 mg capsule or matching placebo following surgery; Post-surgery: starting the day after surgery, 1 celecoxib 200 mg capsule or matching placebo BID for the duration of the study.
  • Drug: Placebo
    Placebo once daily (QD) for 7 days pre-surgery (excluding the day of surgery); Placebo within 2 hours prior to surgery; and post surgery on the same day of the surgery; Placebo twice daily (BID) following the day of surgery and for the duration of the study.
  • Experimental: Celecoxib
    Celecoxib
    Intervention: Drug: Celecoxib
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
22
July 2007
Not Provided

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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00359151
A3191225
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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