UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022261
Receipt number R000025185
Scientific Title Hyperthyroidism controlled by administration of blocking and replacement therapy before inpatient radioisotope therapy for the patient of Graves' disease
Date of disclosure of the study information 2016/05/18
Last modified on 2016/04/15 23:43:09

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Basic information

Public title

Hyperthyroidism controlled by administration of blocking and replacement therapy before inpatient radioisotope therapy for the patient of Graves' disease

Acronym

Thyroid function control in Graves' disease during 131I therapy

Scientific Title

Hyperthyroidism controlled by administration of blocking and replacement therapy before inpatient radioisotope therapy for the patient of Graves' disease

Scientific Title:Acronym

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



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



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

1st name
Middle name
Last name Koichi Ito

Organization

Ito Hospital

Division name

Surgery

Zip code


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

1st name
Middle name
Last name Miho Suzuki

Organization

Ito Hospital

Division name

Internal medicine

Zip code


Address

4-3-6 Jingumae, Shibuya-ku, Tokyo, Japan

TEL

03-3402-7411

Homepage URL


Email

miho-suzuki@ito-hospital.jp


Sponsor or person

Institute

Ito Hospital

Institute

Department

Personal name



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)



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



Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 18 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

Completed

Date of protocol fixation

2014 Year 04 Month 23 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025185


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name