A Multi-Center, Randomized, Double-Blind, Parallel Group Study To Compare The Efficacy And Tolerability Of Valdecoxib And Diclofenac In Patients With A Sprained Ankle

Launched by PFIZER · Apr 30, 2008

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients had sprained their ankle within 48 hours
• • The sprain was a first or second degree ankle sprain of the lateral aspect, specifically: anterior talofibular ligament and/or calcaneofibular ligament
• • At presentation patients were to have had moderate-severe ankle pain, (i.e., patient's assessment of ankle pain, on full weight bearing, using a 100 mm visual analog scale (VAS) was ≥ 45 mm), have a minimum rating of 2 on the Patient's Global Assessment of Ankle Injury and Patient's Assessment of Normal Function/Activity
• • Investigator must have thought that the patient required and was eligible for therapy with an anti-inflammatory agent and/or analgesic to control symptoms
• Exclusion Criteria:
• • Women who were not post-menopausal or surgically sterilized, or who had have a positive urine pregnancy test prior to randomization and/or were not using adequate contraception according to the judgment of the Investigator
• • Patients with a similar injury of the same joint within the last 6 months
• • Clinical evidence of complete rupture of ankle ligaments (third degree sprain), required bed rest, hospitalization, surgical intervention for the ankle injury or non-removable full cast, bilateral occurrence of ankle injury or ankle and knee injury on the same side
• • Patients with esophageal, gastric or duodenal ulcer within 30 days prior to randomization or had active GI or other disease that in the opinion of the investigator would preclude safe participation by the subject in the study.