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
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
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
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
