To evaluate the safety and efficacy of celecoxib versus sodium diclofenac in subjects with acute low back pain
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
244
75 mg oral capsule twice daily for 7 days
400 mg oral capsule followed by 200 mg oral capsule with the evening meal (\>=4 hours from first dose) on Day 1 then 200 mg oral capsule twice daily for 6 days
Pfizer Investigational Site
Salvador, Estado de Bahia, Brazil
Pfizer Investigational Site
Goiânia, Goiás, Brazil
Pfizer Investigational Site
Goiânia, Goiás, Brazil
Pfizer Investigational Site
Change from baseline in patient-rated visual analogue scale (VAS) pain intensity assessment
Time frame: Day 3
Subject's quality of life, as measured by the SF-36 Health Survey
Time frame: Day 7
Physical examination
Time frame: Days 3 and 7
Pain relief score
Time frame: Days 3 and 7
Vital signs
Time frame: Days 3 and 7
Adverse events
Time frame: Days 3 and 7
Change from baseline in VAS pain intensity assessment
Time frame: Day 7
Categorical pain intensity score
Time frame: Days 3 and 7
Subject's global assessment score
Time frame: Days 3 and 7
Subject's functional ability, as measured by the "Roland Morris" Questionnaire about low back pain and disability
Time frame: Day 7
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Goiânia, Goiás, Brazil
Pfizer Investigational Site
Londrina, Paraná, Brazil
Pfizer Investigational Site
Rio de Janeiro, Rio de Janeiro, Brazil
Pfizer Investigational Site
Rio de Janeiro, Rio de Janeiro, Brazil
Pfizer Investigational Site
São Paulo, São Paulo, Brazil
Pfizer Investigational Site
São Paulo, São Paulo, Brazil