UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000016742