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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

Research Project

Project/Area Number 15K09616
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Research Field Pediatrics
Research InstitutionNiigata University

Principal Investigator

Nagasaki Keisuke  新潟大学, 医歯学総合病院, 講師 (70419315)

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)
Project Period (FY) 2015-04-01 – 2018-03-31
Project Status Completed (Fiscal Year 2017)
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)
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
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.

Report

(4 results)
  • 2017 Annual Research Report   Final Research Report ( PDF )
  • 2016 Research-status Report
  • 2015 Research-status Report
  • Research Products

    (5 results)

All 2017 2016 Other

All Presentation (2 results) (of which Invited: 1 results) Remarks (3 results)

  • [Presentation] 小児バセドウ病に対する多施設共同臨床研究~小児バセドウ病に対するコレステロール吸収阻害剤併用療法の多施設ランダム化比較試験~2017

    • Author(s)
      長崎啓祐
    • Organizer
      第60回日本甲状腺学会学術集会
    • Related Report
      2017 Annual Research Report
    • Invited
  • [Presentation] 小児バセドウ病に対する多施設共同臨床研究(~小児バセドウ病に対するコレステロール吸収阻害剤併用療法の多施設ランダム化比較試験~)2016

    • Author(s)
      長崎啓祐
    • Organizer
      第59回日本甲状腺学会学術集会
    • Place of Presentation
      虎ノ門ヒルズフォーラム(東京都港区)
    • Related Report
      2016 Research-status Report
  • [Remarks] 小児期発症の新規バセドウ病を対象とした 多施設共同非盲検ランダム化比較試験

    • URL

      http://www.basedowabctx.org/index.html

    • Related Report
      2017 Annual Research Report
  • [Remarks] 小児期発症の新規バセドウ病を対象とした ランダム化比較試験

    • URL

      http://www.basedowabctx.org/index.html

    • Related Report
      2016 Research-status Report
  • [Remarks] 小児期発症の新規バセドウ病を対象とした多施設共同非盲検ランダム化比較試験

    • URL

      http://www.basedowabctx.org/index.html

    • Related Report
      2015 Research-status Report

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Published: 2015-04-16   Modified: 2019-03-29  

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