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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00359151 |
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 |
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Osteoarthritis Pain |
Drug: Celecoxib Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 22 |
Study Start Date: | November 2006 |
Study Completion Date: | July 2007 |
Arms | Assigned Interventions |
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Celecoxib: Experimental
Celecoxib
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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.
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Placebo: Placebo Comparator
Placebo
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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.
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A3191225 |
Study First Received: | July 28, 2006 |
Last Updated: | May 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00359151 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Perioperative care of total arthroplasty assessing opioid consumption |
Anti-Inflammatory Agents Celecoxib Osteoarthritis Joint Diseases Cyclooxygenase Inhibitors Pain Rheumatic Diseases |
Musculoskeletal Diseases Analgesics, Non-Narcotic Arthritis Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents |
Anti-Inflammatory Agents Celecoxib Molecular Mechanisms of Pharmacological Action Osteoarthritis Joint Diseases Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Rheumatic Diseases Pharmacologic Actions |
Musculoskeletal Diseases Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Arthritis Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents |