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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014383
Receipt No. R000016742
Scientific Title A prospective randomized control study of combination therapy with low-dose methimazole and a cholesterol absorption inhibitor as for the initial treatment of childhood-onset Graves disease
Date of disclosure of the study information 2014/06/27
Last modified on 2021/01/07

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Basic information
Public title A prospective randomized control study of combination therapy with low-dose methimazole and a cholesterol absorption inhibitor as for the initial treatment of childhood-onset Graves disease
Acronym A prospective randomized control study of combination therapy with low-dose methimazole and a cholesterol absorption inhibitor as for the initial treatment of childhood-onset Graves disease
Scientific Title A prospective randomized control study of combination therapy with low-dose methimazole and a cholesterol absorption inhibitor as for the initial treatment of childhood-onset Graves disease
Scientific Title:Acronym A prospective randomized control study of combination therapy with low-dose methimazole and a cholesterol absorption inhibitor as for the initial treatment of childhood-onset Graves disease
Region
Japan

Condition
Condition Graves disease
Classification by specialty
Endocrinology and Metabolism Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study was to examine the efficacy and safety of combination therapy with methimazole and a cholesterol absorption inhibitor as for the initial treatment of childhood-onset Graves disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The normalization rate of levels of free T4 and free T3 at the 4 weeks treatment.
Key secondary outcomes Time to relief of hyperthyroid symptoms
The normalization rate of levels of free T4 and free T3 at the 8, 12, and 24 weeks treatment.
Change of levels of TRAb, Total cholesterol, CPK and 25 hydroxy vitamin D

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 methimazole
Interventions/Control_2 methimazole and a cholesterol absorption inhibitor (colestimide)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
10 years-old <=
Age-upper limit
16 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients with newly diagnosed Graves' disease
2) Serum FT4 value more than 5.0 ng/dl
3) Written informed consent from the patients' parents or legal guardians.
Key exclusion criteria 1) Patients with thyrotoxic crisis
2) Patients who receive pharmacotherapy for diabetes, hepatic and renal disease
3) Medical history of Graves disease. Patients who have already used cholesterol absorption inhibitor.
4) Use of coumarin anticoagulants, digitalis, and bile acids preparations
5) Judged inappropriate for this study by the physicians.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keisuke Nagasaki
Organization Niigata University Medical & Dental Hospital
Division name Pediatrics
Zip code
Address 1-757 Asahimachi-Dori, Chu-Ou-Ku, Niigata city, Niigata
TEL 025-227-2222
Email nagasaki@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keisuke Nagasaki
Organization ABC Tx Group
Division name Department of Pediatrics, Niigata University
Zip code
Address 1-757 Asahimachi-Dori, Chu-Ou-Ku, Niigata city, Niigata
TEL 025-227-2222
Homepage URL
Email nagasaki@med.niigata-u.ac.jp

Sponsor
Institute ABC Tx group
Institute
Department

Funding Source
Organization MEXT(Japan)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 新潟大学医歯学総合病院、都立小児総合医療センター、宮崎大学医学部附属病院、大阪大学医学部附属病院、あいち小児保健医療総合センター、久留米大学病院、群馬大学医学部附属病院、長崎大学病院、金沢医科大学病院、順天堂大学医学部附属順天堂医院、聖マリアンナ医科大学病院、東京医科歯科大学医学部附属病院、東邦大学医療センター大森病院、山形大学医学部附属病院、住友別子病院、川崎市立川崎病院、名古屋市立大学病院、京都府立医科大学附属病院、信州大学医学部附属病院、磐田市立総合病院、北里大学病院、神奈川県立こども医療センター、北海道大学病院、慶応義塾大学病院、国立病院機構 四国こどもとおとなの医療センター、岩手医科大学附属病院、東北大学病院、愛媛大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 27 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2014 Year 05 Month 12 Day
Date of IRB
2013 Year 11 Month 13 Day
Anticipated trial start date
2014 Year 06 Month 27 Day
Last follow-up date
2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 06 Month 26 Day
Last modified on
2021 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016742

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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