Randomized, Double Blind, Multicenter Study of the Safety and Efficacy of Valdecoxib 40 mg Once Daily vs. Diclofenac 75 mg Twice Daily in Subjects With Acute Low Back Pai
- Conditions
- -M545 Low back painLow back painM545
- Registration Number
- PER-039-02
- Lead Sponsor
- PFIZER S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Subject-rated VAS Pain Intensity (0 - 100 mm), which was evaluated using the change from baseline<br>Measure:Subject-rated VAS Pain Intensity (0 - 100 mm), which was evaluated using the change from baseline<br>Timepoints:day 3<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Oswestry Low Back Pain and Disability Questionnaire<br>Measure:Subjects functional capacity as measured by the Oswestry Low Back Pain and Disability Questionnaire<br>Timepoints:day 7<br>