drugset / Trial / NCT00650039

Double-Blind, Randomized Study Of The Analgesic Efficacy And Safety Of Valdecoxib 20 Mg Daily And Valdecoxib 20 Mg Twice Daily Compared To Placebo For Management Of Acute Postsurgical Pain In Anterior Cruciate Ligament (ACL) Reconstruction

NCT00650039

Phase 3 Completed 488 enrolled Pfizer
RandomizedParallel-groupTriple-blindTreatment

Summary

The primary objective was to evaluate the analgesic efficacy of valdecoxib 20 mg daily and valdecoxib 20 mg twice daily compared with placebo in outpatients with moderate-severe pain after arthroscopic anterior cruciate ligament (ACL) reconstruction surgery. Secondary objectives were to compare each valdecoxib dose with placebo on additional measures of pain intensity, health outcomes, the use of rescue medication, and the occurrence of opioid-related symptoms, and to evaluate their safety.

Timeline

Start
2004-03
Primary completion
Completion
2005-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator valdecoxib Small molecule 20 mg Oral

Indications

No indication recorded.