Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Pfizer |
---|---|
Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00446797 |
To assess the efficacy of celecoxib loading dose of 400mg followed by 200 mg twice a day (BID) versus oral non-selective NSAIDs in acute pain due to ankle sprain.
Condition | Intervention | Phase |
---|---|---|
Ankle Sprain |
Drug: Diclofenac Drug: Celecoxib |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Open Label Randomized Multicenter Comparative Study On Celecoxib Efficacy And Safety Versus Non-Selective NSAID In Acute Pain Due To Ankle Sprain |
Enrollment: | 258 |
Study Start Date: | May 2007 |
Study Completion Date: | April 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Non-Selective NSAIDS: Active Comparator
nsNSAIDs used in real-life standard practice for treatment of pain due to ankle sprain.
|
Drug: Diclofenac
Capsules, 100 mg, 1 - 2 capsules per day for 7 days.
|
Celecoxib: Experimental |
Drug: Celecoxib
celecoxib with an initial loading dose of 400 mg followed by 200 mg twice daily (BID) for up to 7 days.
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Brazil, GO | |
Pfizer Investigational Site | |
Goiânia, GO, Brazil, 74075-020 | |
Brazil, RJ | |
Pfizer Investigational Site | |
Rio de Janeiro, RJ, Brazil, 20221-161 | |
Brazil, SP | |
Pfizer Investigational Site | |
São Paulo, SP, Brazil, 01221-900 | |
Pfizer Investigational Site | |
São Paulo, SP, Brazil, 02720-000 | |
Costa Rica, Guadalupe, San Jose | |
Pfizer Investigational Site | |
San Antonio Guadalupe, Guadalupe, San Jose, Costa Rica | |
Ecuador, Pichincha | |
Pfizer Investigational Site | |
Quito, Pichincha, Ecuador | |
Egypt | |
Pfizer Investigational Site | |
Cairo, Egypt | |
Pfizer Investigational Site | |
cairo, Egypt | |
Jordan | |
Pfizer Investigational Site | |
Amman, Jordan, 22110 Jordan | |
Pfizer Investigational Site | |
Amman, Jordan, 11193 Jordan | |
Pfizer Investigational Site | |
Amman, Jordan, 11181 Jordan | |
Mexico, DF | |
Pfizer Investigational Site | |
Mexico, DF, Mexico, 10700 | |
Mexico, Estado de México | |
Pfizer Investigational Site | |
Toluca, Estado de México, Mexico, 50180 | |
Mexico, México | |
Pfizer Investigational Site | |
México DF, México, Mexico, 03020 | |
Mexico, Nuevo León | |
Pfizer Investigational Site | |
San Nicolas de los Garza, Nuevo León, Mexico, 66451 | |
Panama | |
Pfizer Investigational Site | |
Panama City, Panama | |
Peru | |
Pfizer Investigational Site | |
Lima, Peru, L27 | |
Pfizer Investigational Site | |
Lima, Peru, L27 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A3191332 |
Study First Received: | March 9, 2007 |
Last Updated: | September 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00446797 History of Changes |
Health Authority: | Mexico: National Institute of Public Health, Health Secretariat |
Ankle sprain, acute pain, NSAID, celecoxib, |
Anti-Inflammatory Agents Celecoxib Cyclooxygenase Inhibitors Wounds and Injuries Disorders of Environmental Origin Diclofenac Pain |
Analgesics, Non-Narcotic Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Sprains and Strains |
Anti-Inflammatory Agents Celecoxib Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Physiological Effects of Drugs Wounds and Injuries Disorders of Environmental Origin Diclofenac 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 Sprains and Strains |