Open Label Comparative Study On Celecoxib Efficacy And Safety Vs Non-Selective NSAID In Acute Pain Due To Ankle Sprain
NCT ID: NCT00446797
Last Updated: 2021-02-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
278 participants
INTERVENTIONAL
2007-05-31
2008-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Non-Selective NSAIDS
nsNSAIDs used in real-life standard practice for treatment of pain due to ankle sprain.
Non-selective NSAIDS
Non-selective NSAIDs administered at usual (standard) doses.
Celecoxib
Celecoxib
celecoxib with an initial loading dose of 400 mg followed by 200 mg twice daily (BID) for up to 7 days.
Interventions
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Non-selective NSAIDS
Non-selective NSAIDs administered at usual (standard) doses.
Celecoxib
celecoxib with an initial loading dose of 400 mg followed by 200 mg twice daily (BID) for up to 7 days.
Eligibility Criteria
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Inclusion Criteria
* Grade I: When the ligament is stretched but not torn and the anterior talofibular ligament is usually involved. The anterior draw test is negative.
* Grade II: Moderate sprains which usually result in partial tears af the ligaments, primarily the anterior talofibular and possibly the calcaneofibular ligament. Ligamentous laxity may be present and there is moderate swelling.
Exclusion Criteria
* clinical evidence of complete rupture of ankle ligaments (third degree sprain), or
* requirements for bed rest, hospitalization, surgical intervention for the ankle injury; or
* evidence of fractures; or non-removable full cast of any tipe; or
* presence of bilateral occurrence of ankle injury or ipsilateral ankle and knee injury.
18 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Goiânia, Goiás, Brazil
Pfizer Investigational Site
Rio de Janeiro, Rio de Janeiro, Brazil
Pfizer Investigational Site
São Paulo, São Paulo, Brazil
Pfizer Investigational Site
São Paulo, São Paulo, Brazil
Pfizer Investigational Site
San Antonio Guadalupe, Guadalupe, San Jose, Costa Rica
Pfizer Investigational Site
Quito, Pichincha, Ecuador
Pfizer Investigational Site
Cairo, , Egypt
Pfizer Investigational Site
Amman, , Jordan
Pfizer Investigational Site
Amman, , Jordan
Pfizer Investigational Site
Amman, , Jordan
Pfizer Investigational Site
Mexico City, Mexico City, Mexico
Pfizer Investigational Site
San Nicolás de los Garza, Nuevo León, Mexico
Pfizer Investigational Site
Toluca, State of Mexico, Mexico
Pfizer Investigational Site
México DF, , Mexico
Pfizer Investigational Site
Panama City, , Panama
Pfizer Investigational Site
Lima, , Peru
Countries
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References
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Jones P, Lamdin R, Dalziel SR. Oral non-steroidal anti-inflammatory drugs versus other oral analgesic agents for acute soft tissue injury. Cochrane Database Syst Rev. 2020 Aug 12;8(8):CD007789. doi: 10.1002/14651858.CD007789.pub3.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A3191332
Identifier Type: -
Identifier Source: org_study_id
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