Comparison Of Celecoxib 200 Mg Bid, Loxoprofen Sodium 60 Mg Tid And Placebo In Low Back Pain In Japan
NCT00141154
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- 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
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Comparison Of Celecoxib 200 Mg Bid, Loxoprofen Sodium 60 Mg Tid And Placebo In Low Back Pain In Japan | |||
Official Title ICMJE | A Randomized, Multicenter, Active And Placebo Controlled Parallel Group Study To Evaluate The Efficacy And Safety Of Celecoxib (Ym177) 200 Bid Compared To Loxoprofen 60 Mg Tid In Patients With Low Back Pain | |||
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 Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
Condition ICMJE | Low Back Pain | |||
Intervention ICMJE |
| |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 1234 | |||
Original Enrollment ICMJE | 1206 | |||
Study Completion Date ICMJE | Not Provided | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 20 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Japan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00141154 | |||
Other Study ID Numbers ICMJE | A3191174 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | |||
Study Sponsor ICMJE | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | March 2021 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |