The study compares valdecoxib 40 mg once daily vs. rofecoxib 50 mg one daily in treating the signs and symptoms of acute first- or second-degree ankle sprain. The study also evaluated the disability status, tolerability and safety of these treatments.
A3471007 terminated early (30Sep2004) due to safety concerns about continued usage of rofecoxib after worldwide withdrawal of rofecoxib by Merck \& Co Inc
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
45
valdecoxib 80 mg (two 40 mg tablets) by mouth on Day 1 and valdecoxib 40 mg tablet once daily on Days 2-8
rofecoxib 50 mg (two 25 mg capsules) by mouth once daily for 8 days
Instituto Ortopedico de Goiania
Goiânia, Goiás, Brazil
Centro de Traumatologia e Ortopedia
Goiânia, Goiás, Brazil
Hospital Sao Zacarias
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital Mãe de Deus
Porto Alegre, Rio Grande do Sul, Brazil
change from baseline in visual analogue scale (VAS) pain intensity
Time frame: Day 4
patient's assessment of ankle pain VAS (0-100 mm)
Time frame: Days 1, 4 and 8
patient's and physician's global assessment of ankle injury
Time frame: Days 1, 4 and 8
patient's and physician's satisfaction assessments
Time frame: Day 8
patient's assessment of normal function/activity
Time frame: Days 1, 4 and 8
adverse events, physical examinations, and baseline clinical laboratory values
Time frame: Adverse Events: Days 1, 4 and 8; Physical examinations: days 1 and 8; Lab tests: day 1
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Grupo Hospitalar Conceiçao
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Geral do Grajau
São Paulo, São Paulo, Brazil
Unifesp - Hsp
São Paulo, Brazil
SECONCI
São Paulo, Brazil