UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014383 |
|---|---|
| Receipt number | 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 08:16:11 |
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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
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
nagasaki@med.niigata-u.ac.jp
Sponsor or person
Institute
ABC Tx group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016742
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| Registered date | File name |
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