To compare the analgesic efficacy, safety, and tolerability of valdecoxib versus piroxicam in subjects with moderate to severe menstrual cramping pain associated with primary dysmenorrhea.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
154
piroxicam 40 mg capsule QD for up to the first 3 days of the menstrual cycle
valdecoxib 40 mg capsule twice a day (BID), taken as required, on the first day of treatment in the menstrual cycle followed by oral valdecoxib 40 mg once a day (QD) for up to the first 3 days of the menstural cycle
Pfizer Investigational Site
Salvador, Estado de Bahia, Brazil
Pfizer Investigational Site
Goiânia, Goiás, Brazil
Pfizer Investigational Site
Belo Horizonte, Minas Gerais, Brazil
Total pain relief were calculated as the summed weighted pain releif scores
Time frame: 8 hours
adverse events
Time frame: approximately 5 days after treated cycle
laboratory analyses
Time frame: screening
Subjects' global evaluation of the study drug
Time frame: 8 hours and 72 hours
Summed pain intensity difference
Time frame: 8 hours
Percent of subjects who took rescue medication
Time frame: 72 hours
Percent of subjects who took the second dose of study medication
Time frame: 72 hours
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Pfizer Investigational Site
Belo Horizonte, Minas Gerais, Brazil
Pfizer Investigational Site
Rio de Janeiro, Rio de Janeiro, Brazil
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, Brazil
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, Brazil
Pfizer Investigational Site
São Paulo, São Paulo, Brazil
Pfizer Investigational Site
São Paulo, Brazil
Pfizer Investigational Site
São Paulo, Brazil