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Sponsored by: |
Pfizer |
---|---|
Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00671320 |
To determine whether valdecoxib 40 mg twice a day the first day and then 40mg once a day until Day 7, was at least as effective as diclofenac 75 mg twice a day for 7 days, in treating acute first or second degree ankle sprain. The study also compared valdecoxib and diclofenac with respect to time to onset of pain relief (measured after the first dose), tolerability (adverse events) and time to return to Normal Function/Activity, among other measures.
Condition | Intervention | Phase |
---|---|---|
Pain Sprains and Strains Sprain |
Drug: valdecoxib Drug: diclofenac |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Randomized, Double-Blind, Parallel Group Study To Compare The Efficacy And Tolerability Of Valdecoxib Vs. Diclofenac In Ankle Sprain |
Enrollment: | 202 |
Study Start Date: | December 2002 |
Study Completion Date: | October 2003 |
Arms | Assigned Interventions |
---|---|
Arm 1: Active Comparator |
Drug: valdecoxib
valdecoxib 40 mg tablet by mouth twice daily (BID) on Day 1 and then once daily (QD) on Days 2 to 7
|
Arm 2: Active Comparator |
Drug: diclofenac
diclofenac 75 mg capsule by mouth twice daily (BID) for 7 days
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Argentina | |
Pfizer Investigational Site | |
Buenos Aires, Argentina | |
Argentina, Buenos Aires | |
Pfizer Investigational Site | |
Avellaneda, Buenos Aires, Argentina, 1872 | |
Pfizer Investigational Site | |
San Isidro, Buenos Aires, Argentina, 1642 | |
Chile | |
Pfizer Investigational Site | |
Santiago, Chile | |
Chile, RM | |
Pfizer Investigational Site | |
Santiago, RM, Chile | |
Colombia, Antioquia | |
Pfizer Investigational Site | |
Medellin, Antioquia, Colombia, (574) 5141516 | |
Colombia, Cundinamarca | |
Pfizer Investigational Site | |
Bogota, Cundinamarca, Colombia, (57) 310-2322198 | |
Pfizer Investigational Site | |
Bogota, Cundinamarca, Colombia, (57) 310-8849622 | |
Colombia, Cundinarmarca | |
Pfizer Investigational Site | |
Bogota, Cundinarmarca, Colombia, (571) 6 164278 | |
Colombia, Santander | |
Pfizer Investigational Site | |
Bucaramanga, Santander, Colombia, (577) 6 395409 | |
Colombia, Valle del Cauca | |
Pfizer Investigational Site | |
Calli, Valle del Cauca, Colombia, (57) 310-8259712 | |
Pfizer Investigational Site | |
Cali, Valle del Cauca, Colombia, (57) 315-5410469 | |
Mexico, Nuevo Leon | |
Pfizer Investigational Site | |
Monterrey, Nuevo Leon, Mexico, 64460 | |
Peru | |
Pfizer Investigational Site | |
Lima, Peru, 27 | |
Pfizer Investigational Site | |
Lima, Peru |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | VALA-0513-146, A3471037 |
Study First Received: | March 31, 2008 |
Last Updated: | April 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00671320 |
Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
acute ankle sprain, acute pain, South America |
Wounds and Injuries Diclofenac Disorders of Environmental Origin |
Pain Valdecoxib Sprains and Strains |
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 |