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Clinical Trial Name - Comparison Of Celecoxib 200 Mg Bid, Loxoprofen Sodium 60 Mg Tid And Placebo In Low Back Pain In Ja
| Original Study ID : A3191174 |
| NCT ID : NCT00141154 |
| Brief Title : Comparison Of Celecoxib 200 Mg Bid, Loxoprofen Sodium 60 Mg Tid And Placebo In Low Back Pain In Japan |
| Official Title : 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. |
| Source : Pfizer |
| Overall Status : Completed |
| Start Date : October 2004 |
| Official Title : Phase 3 |
| Phase : Interventional |
| Study Design : Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Enrollment : 1206 |
| Verification Date : September 2007 |
| First Received Date : August 30, 2005 |
| Trial Eligibility |
| Criteria : 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 |
| Gender : Both |
| Minimum Age : 20 Years |
| Maximum Age : N/A |
| Healthy Volunteers : No |
| Facilities |
| Facility Name : Pfizer Investigational Site |
| City : Tokyo |
| Zip Code : 140-0011 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Chiba |
| Zip Code : 266-0031 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Fukuoka |
| Zip Code : 266-0031 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Fukuoka |
| Zip Code : 810-0004 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Funabashi-shi |
| State : Chiba |
| Zip Code : 810-0004 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Matsudo-shi |
| State : Chiba |
| Zip Code : 810-0004 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Funabashi |
| State : Chiba |
| Zip Code : 273-0035 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Fukuoka-shi |
| State : Fukuoka |
| Zip Code : 273-0035 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Sapporo-shi |
| State : Hokkaido |
| Zip Code : 273-0035 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Sapporo |
| State : Hokkaido |
| Zip Code : 273-0035 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Chitose |
| State : Hokkaido |
| Zip Code : 066-0026 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Nishinomiya |
| State : Hyogo |
| Zip Code : 662-0838 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Kobe |
| State : Hyogo |
| Zip Code : 650 0004 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Katougun |
| State : Hyogo |
| Zip Code : 673-1462 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Sagamihara-shi |
| State : Kanagawa |
| Zip Code : 673-1462 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Yokohama-shi |
| State : Kanagawa |
| Zip Code : 673-1462 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Yokohama |
| State : Kanagawa |
| Zip Code : 673-1462 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Tokorozawa |
| State : Saitama |
| Zip Code : 673-1462 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Minamisaitama-gun |
| State : Saitama |
| Zip Code : 673-1462 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Saitama-shi |
| State : Saitama |
| Zip Code : 673-1462 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Hatogaya-shi |
| State : Saitama |
| Zip Code : 673-1462 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Kumagayashi |
| State : Saitama |
| Zip Code : 3600854 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Kumagaya-shi |
| State : Saitama |
| Zip Code : 3600012 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Adachi-Ku |
| State : Tokyo |
| Zip Code : 3600012 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Itabashi-ku |
| State : Tokyo |
| Zip Code : 3600012 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Sumida-ku |
| State : Tokyo |
| Zip Code : 131-0043 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Bunkyou-ku |
| State : Tokyo |
| Zip Code : 131-0043 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Edogawa-ku |
| State : Tokyo |
| Zip Code : 131-0043 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Setagaya-ku |
| State : Tokyo |
| Zip Code : 131-0043 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Suginami-ku |
| State : Tokyo |
| Zip Code : 131-0043 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Ota-Ku |
| State : Tokyo |
| Zip Code : 131-0043 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Meguro-Ku |
| State : Tokyo |
| Zip Code : 131-0043 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Shinjyuku-ku |
| State : Tokyo |
| Zip Code : 131-0043 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Meguro-ku |
| State : Tokyo |
| Zip Code : 131-0043 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Shibuya-ku |
| State : Tokyo |
| Zip Code : 131-0043 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Nerima-ku |
| State : Tokyo |
| Zip Code : 131-0043 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : ,Shinjyuku-ku |
| State : Tokyo |
| Zip Code : 131-0043 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Nakano-ku |
| State : Tokyo |
| Zip Code : 131-0043 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Toyoshima-ku |
| State : Tokyo |
| Zip Code : 131-0043 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : koito-ku |
| State : Tokyo |
| Zip Code : 131-0043 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Shinagawa-ku |
| State : Tokyo |
| Zip Code : 140-0001 |
| Country : Japan |
| Facility Name : Pfizer Investigational Site |
| City : Ota-Ku |
| State : Tokyo |
| Zip Code : 145-0066 |
| Country : Japan |
| OutComes |
| Primary OutComes |
| Measure : Patient's pain assessment (VAS: Visual Analogue Scale) |
| Secondary OutComes |
| Measure : Patient's global assessment (VAS), Physician's global assessment (VAS), Roland Morris Disability Questionnaire (RDQ) |
| Interventions |
| Type : Drug |
| Name : Celecoxib |
| Type : Drug |
| Name : Placebo |
| Type : Drug |
| Name : Loxoprofen |
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