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A Double-blind, Double-dummy, Multicenter, Randomized Study of the Efficacy and Tolerability of Valdecoxib 40 mg Versus Rofecoxib 50 mg in Treating the Symptoms of Ankle Sprain

Last updated on February 20, 2019

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Study Location
Instituto Ortopedico de Goiania
Goiania, Goias, 74210-030 Brazil
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acute Pain
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 had sustained, no more than 48 hours prior to the first dose of study
medication, a first- or second-degree ankle sprain of the lateral ligament,
specifically: anterior talofibular ligament and/or posterior talofibular ligament
and/or calcaneofibular ligament

- At presentation, all patients were to have Patient's Assessment of Ankle Pain Visual
Analog Scale (VAS) (0-100mm) of ≥45 mm in the orthostatic position on full weight
bearing (ie, moderate to severe pain), had a minimum rating of 2 on the Patient's
Global Assessment of Ankle Injury and Patient's Assessment of Normal Function/Activity

- Tthe investigator opinion was that each patient required, and was eligible for,
therapy with an anti-inflammatory agent and/or analgesics to control symptoms

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

None reported

NCT00657449
Pfizer
Terminated
A Double-blind, Double-dummy, Multicenter, Randomized Study of the Efficacy and Tolerability of Valdecoxib 40 mg Versus Rofecoxib 50 mg in Treating the Symptoms of Ankle Sprain

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