NCT00671320

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

A Multi-Center, Randomized, Double-Blind, Parallel Group Study To Compare The Efficacy And Tolerability Of Valdecoxib Vs. Diclofenac In Ankle Sprain

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine whether valdecoxib 40 mg twice a day the first day and then 40mg once a day until Day 7, was at least as effective as diclofenac 75 mg twice a day for 7 days, in treating acute first or second degree ankle sprain. The study also compared valdecoxib and diclofenac with respect to time to onset of pain relief (measured after the first dose), tolerability (adverse events) and time to return to Normal Function/Activity, among other measures.

Conditions

• Pain
• Sprains and Strains
• Sprain

Interventions

Type	Name	Description
DRUG	valdecoxib	valdecoxib 40 mg tablet by mouth twice daily (BID) on Day 1 and then once daily (QD) on Days 2 to 7
DRUG	diclofenac	diclofenac 75 mg capsule by mouth twice daily (BID) for 7 days

Timeline

• Start date: 2002-12-01
• Completion: 2003-10-01
• First posted: 2008-05-05
• Last updated: 2008-05-05

Locations

15 sites across 5 countries: Argentina, Chile, Colombia, Mexico, Peru