Status:
COMPLETED
Open Label Comparative Study On Celecoxib Efficacy And Safety Vs Non-Selective NSAID In Acute Pain Due To Ankle Sprain
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Ankle Sprain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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.
Eligibility Criteria
Inclusion
- Patients with first acute ankle sprain episode in the last six months classified as grade I or II, confirmed by X-rays, according to the following definitions:
- 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
- Patients who have a similar injury of the same joint within the last six months; or
- 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.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
278 Patients enrolled
Trial Details
Trial ID
NCT00446797
Start Date
May 1 2007
End Date
April 1 2008
Last Update
February 21 2021
Active Locations (16)
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1
Pfizer Investigational Site
Goiânia, Goiás, Brazil, 74075-020
2
Pfizer Investigational Site
Rio de Janeiro, Rio de Janeiro, Brazil, 20221-161
3
Pfizer Investigational Site
São Paulo, São Paulo, Brazil, 01221-900
4
Pfizer Investigational Site
São Paulo, São Paulo, Brazil, 02720-000