A prospective randomized control study of combination therapy with methimazole and a cholesterol absorption inhibitor as for the initial treatment of childhood-onset Graves disease
| Project/Area Number |
15K09616
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Multi-year Fund |
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| Section | 一般 |
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| Research Field |
Pediatrics
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| Research Institution | Niigata University |
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Principal Investigator |
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| Co-Investigator(Kenkyū-buntansha) |
高桑 聖 大阪大学, 医学系研究科, 招へい教員 (00313643)
田久保 憲行 順天堂大学, 医学部, 准教授 (20306583)
澤田 浩武 宮崎大学, 医学部, 教授 (40332895)
長谷川 行洋 東京都立小児総合医療センター(臨床研究部), なし, その他 (70172898)
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| Project Period (FY) |
2015-04-01 – 2018-03-31
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| Project Status |
Completed (Fiscal Year 2017)
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| Budget Amount *help |
¥4,550,000 (Direct Cost: ¥3,500,000、Indirect Cost: ¥1,050,000)
Fiscal Year 2017: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000)
Fiscal Year 2016: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
Fiscal Year 2015: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
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| Keywords | バセドウ病 / ランダム化比較試験 / 介入研究 / メチマゾール / コレステロール吸収阻害剤 / Basedow病 / 小児期発症 |
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| Outline of Final Research Achievements |
For the first time worldwide, a randomized controlled trial was initiated to determine whether the combination therapy of methimazole, an antithyroid agent, and a cholesterol absorption inhibitor was useful as an initial therapy for patients with a new onset of childhood Graves’ disease with moderate-to-severe hyperthyroidism.
The target number of patients was 70 patients, with 51 patients having been enrolled so far. At the beginning of the trial, 26 facilities were included for participation, but currently, 41 facilities are included, and the research protocol is in place. However, the target number of patients has not been reached. Therefore, we plan to extend the research period, without continuing the interim analysis.
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Report
(4 results)
Research Products
(5 results)
