Status:
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
Lead Sponsor:
Pfizer
Conditions:
Low Back Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The pain relief, safety, and tolerability of valdecoxib 40 mg once daily compared with diclofenac 75 mg twice daily for acute low back pain was studied. The effect of valdecoxib on the patient's level...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2003
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT00649610
Start Date
November 1 2002
End Date
May 1 2003
Last Update
April 10 2008
Active Locations (29)
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1
Pfizer Investigational Site
Bs. As., Argentina
2
Pfizer Investigational Site
Buenos Aires, Argentina, C1221ACI
3
Pfizer Investigational Site
Goiânia, Goiás, Brazil, 74085-450
4
Pfizer Investigational Site
Curitiba, Paraná, Brazil, 80430-210