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Open Label Comparative Study On Celecoxib Efficacy And Safety Vs Non-Selective NSAID In Acute Pain Due To Ankle Sprain

Last updated on February 20, 2019

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Study Location
Pfizer Investigational Site
Goiânia, GO, 74075-020 Brazil
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ankle Sprain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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 criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT00446797
Pfizer
Completed
Open Label Comparative Study On Celecoxib Efficacy And Safety Vs Non-Selective NSAID In Acute Pain Due To Ankle Sprain

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