Comparison Of Celecoxib 200 Mg Bid, Loxoprofen Sodium 60 Mg Tid And Placebo In Low Back Pain In Japan
Phase 3
Completed
- Conditions
- Low Back Pain
- Registration Number
- NCT00141154
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1234
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Patient's pain assessment (VAS: Visual Analogue Scale)
- Secondary Outcome Measures
Name Time Method Patient's global assessment (VAS), Physician's global assessment (VAS), Roland Morris Disability Questionnaire (RDQ)
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇯🇵Tokyo, Japan