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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000004825 |
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Date of registration:
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06/01/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A randomized comparative study of Celecoxib and Limaprost alfadex on the patients with lumber spinal stenosis for the effectiveness for symptoms and QOL
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Scientific title:
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A randomized comparative study of Celecoxib and Limaprost alfadex on the patients with lumber spinal stenosis for the effectiveness for symptoms and QOL - A randomized comparative study of medications for patients with lumber spinal stenosis |
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Date of first enrolment:
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2011/01/01 |
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Target sample size:
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134 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005745 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Phase III
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Countries of recruitment
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Japan
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Contacts
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Name:
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Koichi Hashimoto |
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Address:
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1-1-1, Tennodai, Tsukuba, Ibaraki
Japan |
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Telephone:
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029-853-3076 |
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Email:
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Affiliation:
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University of Tsukuba Tsukuba Critical Path Research and Education Integrated Leading Center, Course of life-style related |
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Name:
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Naotaka Mamizuka |
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Address:
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3-2-7, Miyamachi, Mito, Ibaraki
Japan |
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Telephone:
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029-231-2371 |
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Email:
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Affiliation:
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Mito Medical Center University of Tsukuba Orthopedics |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1.Congenital lumbar spinal stenosis 2.Operation for lumbar spinal stenosis before three months 3.Indication for operation 4.Taking NSAIDs, Limaprost and Steroids before a week 5.Exclusion criteria a)ASO and below 0.9 of ABI b)Cerebral infarction c)Gait disturbance with Knee and hip osteoarthritis d)Diabetes (HbA1c>10% or diabetic neuropathy) 6. Severe low back pain and vertebral body fracture 7. Severe systemic past history such as heart, liver or kidney disease 8. Peptic ulcer 9. Severe abnormal symptom of blood 10. Pregnant or intend to become pregnant during the study period 11. History of hypersensitivity to Limaprost, celecoxib and sulfonamide 12. Aspirin-induced asthma 13. Patients who were recognized unsuitable for this study by primary physician
Age minimum:
40years-old
Age maximum:
85years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Lumbar spinal stenosis
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Intervention(s)
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15ug/day Limaprost arfadex for 8 weeks
200mg/day Celecoxib for 8 weeks
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Primary Outcome(s)
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Zurich claudication questionnaire
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Secondary Outcome(s)
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6-minute walk test JOA back pain evaluation questionnaire SF-36 Lumber extension test Safety: adverse events
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Source(s) of Monetary Support
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JA Ibaraki Public Welfare Federation
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General Incorporated Association Orthopedics Network Tsukuba
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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