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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00653354 |
To assess the analgesic efficacy and general safety of 2 dosing regimens of valdecoxib compared to placebo on the first post-operative day in patients with moderate or severe pain following bunionectomy surgery.
Condition | Intervention | Phase |
---|---|---|
Pain, Post-Surgical |
Drug: valdecoxib Drug: valdecoxib/placebo Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Assessment Of The Analgesic Efficacy Of The Dosing Regimen Of Valdecoxib Compared To Placebo Patients In Pain Following Bunionectomy |
Enrollment: | 360 |
Study Start Date: | December 2002 |
Study Completion Date: | March 2003 |
Arms | Assigned Interventions |
---|---|
Arm 1: Active Comparator |
Drug: valdecoxib
valdecoxib 40 mg tablet by mouth within 6 hours of surgery followed by valdecoxib 20 mg tablet by mouth 1 to 12 hours after the first dose
|
Arm 2: Active Comparator |
Drug: valdecoxib/placebo
valdecoxib 40 mg tablet by mouth within 6 hours of surgery followed by placebo 1 to 12 hours after the first dose
|
Arm 3: Placebo Comparator |
Drug: placebo
placebo within 6 hours of surgery followed by placebo 1 to 12 hours after the first dose
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
Pfizer Investigational Site | |
Phoenix, Arizona, United States, 85015 | |
Pfizer Investigational Site | |
Phoenix, Arizona, United States, 85020 | |
Pfizer Investigational Site | |
Phoenix, Arizona, United States, 85032 | |
Pfizer Investigational Site | |
Phoenix, Arizona, United States, 85016 | |
Pfizer Investigational Site | |
Tempe, Arizona, United States, 85281 | |
United States, California | |
Pfizer Investigational Site | |
Anaheim, California, United States, 92701 | |
Pfizer Investigational Site | |
Santa Ana, California, United States, 92701 | |
Pfizer Investigational Site | |
Tustin, California, United States, 92780 | |
Pfizer Investigational Site | |
Chula Vista, California, United States, 91911 | |
Pfizer Investigational Site | |
San Diego, California, United States, 92114 | |
United States, Kentucky | |
Pfizer Investigational Site | |
Lexington, Kentucky, United States, 40504 | |
Pfizer Investigational Site | |
Lexington, Kentucky, United States, 40509 | |
Pfizer Investigational Site | |
Lexington, Kentucky, United States, 40515 | |
United States, Pennsylvania | |
Pfizer Investigational Site | |
Altoona, Pennsylvania, United States, 16602 | |
Pfizer Investigational Site | |
Duncansville, Pennsylvania, United States, 16635 | |
United States, Tennessee | |
Pfizer Investigational Site | |
Johnson City, Tennessee, United States, 37601 | |
Pfizer Investigational Site | |
Johnson City, Tennessee, United States, 37604 | |
Pfizer Investigational Site | |
Johnson City,, Tennessee, United States, 37601 | |
United States, Texas | |
Pfizer Investigational Site | |
San Antonio, Texas, United States, 78229 | |
Pfizer Investigational Site | |
San Antonio, Texas, United States, 78240 | |
United States, Utah | |
Pfizer Investigational Site | |
Salt Lake City, Utah, United States, 84117 | |
Pfizer Investigational Site | |
Salt Lake City, Utah, United States, 84123 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | VALA-0513-149, A3471086 |
Study First Received: | April 1, 2008 |
Last Updated: | April 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00653354 |
Health Authority: | United States: Food and Drug Administration |
hallux valgus |
Hallux Valgus Pain Valdecoxib |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Pharmacologic Actions Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |