UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Hyperthyroidism controlled by administration of blocking and replacement therapy before inpatient radioisotope therapy for the patient of Graves' disease
Title of the study (Brief title)	Thyroid function control in Graves' disease during 131I therapy
Region	Japan

Condition
Condition	Graves' disease
Classification by specialty	Medicine in general Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to investigate an approach to RIT without exacerbating the hyperthyroidism in Graves' disease patients with giant goiters.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Free thyroxine (FT4) and free triiodothyronine (FT3) levels during RIT
Key secondary outcomes

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Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Intervention: the blocking and replacement therapy (BRT) group (BR group), which received twice the amount of previously given ATD and LT4 replacement starting 2 or more months prior to RIT.
Interventions/Control_2	Control: the control group (C group), which received ATD treatment alone prior to RIT.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	19 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	i) deemed difficult to achieve remission with ATD treatment; ii) patient requested RIT; iii) estimated thyroid gland volume of 80 ml or greater
Key exclusion criteria	Inorganic iodine administered in combination, poorly controlled cardiac disease, diabetes, kidney disease, severe liver disease, and active ocular disease. However, patients with concomitant controlled cardiac diseases and diabetes were treated in the BR group.
Target sample size	23

Research contact person
Name of lead principal investigator	Koichi Ito
Organization	Ito Hospital
Division name	Surgery
Address	4-3-6 Jingumae, Shibuya-ku, Tokyo, Japan
TEL	03-3402-7411
Email	miho-suzuki@ito-hospital.jp

Public contact
Name of contact person	Miho Suzuki
Organization	Ito Hospital
Division name	Internal medicine
Address	4-3-6 Jingumae, Shibuya-ku, Tokyo, Japan
TEL	03-3402-7411
Homepage URL
Email	miho-suzuki@ito-hospital.jp

Sponsor
Institute	Ito Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Ito Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 04 Month 23 Day
Anticipated trial start date	2014 Year 04 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 05 Month 10 Day
Last modified on	2016 Year 04 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025185