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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00633438 |
To compare total analgesic use at 24 hours after arthroscopic knee surgery in celecoxib-treated versus placebo-treated patients
Condition | Intervention | Phase |
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Arthroscopy |
Other: Placebo Drug: Celecoxib |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study |
Official Title: | A Double-Blind, Placebo-Controlled, Randomized Comparison Study of the Efficacy of Celebrex 400 mg Single Dose Pre and Celebrex 200 mg Post Ambulatory Arthroscopic Knee Surgery for Total Analgesic Use After Surgery |
Enrollment: | 204 |
Study Start Date: | January 2004 |
Study Completion Date: | June 2004 |
Arms | Assigned Interventions |
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B: Placebo Comparator |
Other: Placebo
Matched oral capsule administered 1 hour prior to surgery and matched oral capsule administered post surgery as needed
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A: Experimental |
Drug: Celecoxib
400 mg oral capsule as single dose administered 1 hour prior to surgery and 200 mg oral capsule as single dose administered post surgery as needed
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Inclusion criteria:
Exclusion Criteria:
Exclusion criteria:
United States, Arizona | |
Pfizer Investigational Site | |
Phoenix, Arizona, United States, 85023 | |
United States, Florida | |
Pfizer Investigational Site | |
ST. PETERSBURG, Florida, United States, 33713 | |
Pfizer Investigational Site | |
St. Petersburg, Florida, United States, 33713 | |
United States, Maryland | |
Pfizer Investigational Site | |
BALTIMORE, Maryland, United States, 21218 | |
Pfizer Investigational Site | |
Timonium, Maryland, United States, 21093 | |
United States, Massachusetts | |
Pfizer Investigational Site | |
SPRINGFIELD, Massachusetts, United States, 01109 | |
Pfizer Investigational Site | |
Springfield, Massachusetts, United States, 01104 | |
Pfizer Investigational Site | |
Springfield, Massachusetts, United States, 01107 | |
Pfizer Investigational Site | |
Springfield, Massachusetts, United States, 01199 | |
United States, Missouri | |
Pfizer Investigational Site | |
Springfield, Missouri, United States, 65807 | |
United States, South Carolina | |
Pfizer Investigational Site | |
COLUMBIA, South Carolina, United States, 29204 | |
Pfizer Investigational Site | |
Columbia, South Carolina, United States, 29212 | |
Pfizer Investigational Site | |
Columbia, South Carolina, United States, 29202 | |
Pfizer Investigational Site | |
Orangeburg, South Carolina, United States, 29110 | |
United States, Tennessee | |
Pfizer Investigational Site | |
Johnson City, Tennessee, United States, 37601 | |
United States, Texas | |
Pfizer Investigational Site | |
San Antonio, Texas, United States, 78205 | |
Pfizer Investigational Site | |
San Antonio, Texas, United States, 78209 | |
Pfizer Investigational Site | |
San Antonio, Texas, United States, 78229 | |
Pfizer Investigational Site | |
San Antonio, Texas, United States, 78240 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A3191067 |
Study First Received: | March 4, 2008 |
Last Updated: | March 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00633438 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Knee Surgery
Arthroscopic Surgery |
Anti-Inflammatory Agents Celecoxib Analgesics, Non-Narcotic Cyclooxygenase Inhibitors |
Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents |
Anti-Inflammatory Agents Celecoxib Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Pharmacologic Actions Sensory System Agents |
Analgesics, Non-Narcotic Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |