drugset / Trial / 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

NCT00671320

Phase 4 Completed 202 enrolled Pfizer
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2002-12
Primary completion
Completion
2003-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Diclofenac Other / unclassified 75 mg Oral
Comparator valdecoxib Small molecule 40 mg Oral

Indications

No indication recorded.