Celebrex Total Knee Arthroplasty Study - Full Text View

Purpose

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	Intervention	Phase
Osteoarthritis Pain	Drug: Celecoxib Drug: Placebo	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement Osteoarthritis Rehabilitation

Drug Information available for: Celecoxib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	22
Study Start Date:	November 2006
Study Completion Date:	July 2007

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359151

Locations

United States, Colorado
Pfizer Investigational Site
Aurora, Colorado, United States, 80012
Pfizer Investigational Site
E, Colorado, United States, 80113
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

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00359151 History of Changes
Other Study ID Numbers:	A3191225
Study First Received:	July 28, 2006
Last Updated:	May 22, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Perioperative care of total arthroplasty assessing opioid consumption

Additional relevant MeSH terms:

Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 19, 2013