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

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Anti-Inflammatory Agents, Non-Steroidal; Celecoxib

Criteria

Inclusion Criteria:

• 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:

• 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.