Status:
COMPLETED
Safety And Efficacy Of Celecoxib Versus Sodium Diclofenac In The Treatment Of Acute Low Back Pain
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Low Back Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
To evaluate the safety and efficacy of celecoxib versus sodium diclofenac in subjects with acute low back pain
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Aged between 18 and 65 years
- Acute low back pain that falls into 1st or 2nd class of 'Quebec Task Force' classification of moderate to severe intensity (\>50 mm in the VAS)
- Acute low back pain onset \<72 hours prior to study inclusion and \>6 weeks after the last acute low back pain episode
- Exclusion criteria:
- Scoliosis or known history of inflammatory arthritis, chronic pain, metastasis, Paget's disease, or any other disease that cause pain
- Low back pain from major trauma or visceral disorder
- Esophageal ulcers, gastric or duodenal ulcers or bleeding within 30 days prior to being administered study drug
Exclusion
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2004
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT00640432
Start Date
October 1 2003
End Date
October 1 2004
Last Update
February 2 2021
Active Locations (9)
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1
Pfizer Investigational Site
Salvador, Estado de Bahia, Brazil, 40420-000
2
Pfizer Investigational Site
Goiânia, Goiás, Brazil, 74043-110
3
Pfizer Investigational Site
Goiânia, Goiás, Brazil, 74075-020
4
Pfizer Investigational Site
Goiânia, Goiás, Brazil, 74605-050