Status:
COMPLETED
Comparison Of Celecoxib 200 Mg Bid, Loxoprofen Sodium 60 Mg Tid And Placebo In Low Back Pain In Japan
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Low Back Pain
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
To verify the superiority of celecoxib (YM177) 200 mg bid to placebo in treatment of patients with low back pain as well as non-inferiority to loxoprofen sodium 60 mg tid.
Eligibility Criteria
Inclusion
- Patients who have the major site of the low back pain at the 12th thoracic vertebra or lower
- Patients who have had low back pain for at least two weeks
Exclusion
- Patients who have a previous history or complication of rheumatoid arthritis, spondylarthrosis with negative serum reaction (ankylosing spondylarthritis, psoriatic arthritis), metastasis of tumor, Paget's disease, fibromyalgia, tumor or infection of spinal cord or intervertebral disc, or any other disease which can cause systemic pain
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
1234 Patients enrolled
Trial Details
Trial ID
NCT00141154
Start Date
October 1 2004
Last Update
March 3 2021
Active Locations (38)
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1
Pfizer Investigational Site
Funabashi, Chiba, Japan, 273-0035
2
Pfizer Investigational Site
Funabashi-shi, Chiba, Japan
3
Pfizer Investigational Site
Matsudo-shi, Chiba, Japan
4
Pfizer Investigational Site
Fukuoka, Fukuoka, Japan