Celebrex Total Knee Arthroplasty Study

Phase 4TerminatedNCT00359151

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Osteoarthritis Pain

Interventions

CelecoxibDRUG

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.

PlaceboDRUG

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

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 (7)

Pfizer Investigational Site

Aurora, Colorado, United States

Pfizer Investigational Site

Englewood, Colorado, United States

Pfizer Investigational Site

Chicago, Illinois, United States

Pfizer Investigational Site

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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 Outcomes

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

To assess the safety and tolerability of celecoxib in this study population.

Time frame: 19 July 2007

Data from ClinicalTrials.gov

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