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Randomized, Double Blind, Multicenter Study of the Safety and Efficacy of Valdecoxib 40 mg Once Daily Compared With Diclofenac 75 mg Twice Daily in Acute Low Back Pain

Last updated on February 23, 2019

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Study Location
Pfizer Investigational Site
Bs. As., , Argentina
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Low Back Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Acute low back pain, defined as either class 1a or class 2a according to the Quebec
Task Force Classification and categorized as moderate-severe in the Pain Intensity
Categorical Scale and Visual analogue score (VAS) greater or equal to 50 mm

- Acute low back pain was to have started at least 72 hours prior to inclusion in the
trial and more than 6 weeks after the last episode of acute low back pain

- History of at least 1 reported episode of acute low back pain in the last 5 years

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- History of inflammatory arthritis, chronic pain, metastasis, Paget's disease, or other
diseases known to cause pain

- Moderate to severe scoliosis

- Back pain due to major trauma or visceral disorder

- Unwilling to refrain from commencing concomitant physiotherapy

- Active or suspected esophageal, gastric pyloric channel, or duodenal ulceration or
bleeding within 30 days prior to the first dose of study medication

- Any known laboratory abnormality, which in the opinion of the investigator, would
contraindicate study participation

- Subject was pregnant or lactating woman , or was a woman of childbearing potential not
using an acceptable method of contraception

NCT00649610
Pfizer
Completed
Randomized, Double Blind, Multicenter Study of the Safety and Efficacy of Valdecoxib 40 mg Once Daily Compared With Diclofenac 75 mg Twice Daily in Acute Low Back Pain

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