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Celebrex Total Knee Arthroplasty Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00359151
Recruitment Status : Terminated (This study was terminated early due to slow enrollment.)
First Posted : August 1, 2006
Last Update Posted : December 4, 2018
Sponsor:
Information provided by:
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Pain Drug: Celecoxib Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : November 2006
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Celecoxib
Celecoxib
 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.
Placebo Comparator: Placebo
Placebo
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. To assess the safety and tolerability of celecoxib in this study population. [ Time Frame: 19 July 2007 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00359151


Locations
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United States, Colorado
Pfizer Investigational Site
Aurora, Colorado, United States, 80012
Pfizer Investigational Site
Englewood, Colorado, United States, 80110
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60612
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19107
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19140
United States, Texas
Pfizer Investigational Site
Bellaire, Texas, United States, 77410
Pfizer Investigational Site
Houston, Texas, United States, 77030
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00359151    
Other Study ID Numbers: A3191225
First Posted: August 1, 2006    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018
Keywords provided by Pfizer:
Perioperative care of total arthroplasty assessing opioid consumption
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Celecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action