UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001087 |
|---|---|
| Receipt number | R000001319 |
| Scientific Title | A randomized open-labelled controlled prospective study to investigate the effect of inactive iodine and lithium carbonate on radioiodine therapy in patients with Graves' disease |
| Date of disclosure of the study information | 2008/03/19 |
| Last modified on | 2019/04/23 18:21:59 |
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Basic information
Public title
A randomized open-labelled controlled prospective study to investigate the effect of inactive iodine and lithium carbonate on radioiodine therapy in patients with Graves' disease
Acronym
A clinical study to investigate the effect of inactive iodine and lithium carbonate in radioiodine therapy of Graves' disease
Scientific Title
A randomized open-labelled controlled prospective study to investigate the effect of inactive iodine and lithium carbonate on radioiodine therapy in patients with Graves' disease
Scientific Title:Acronym
A clinical study to investigate the effect of inactive iodine and lithium carbonate in radioiodine therapy of Graves' disease
Region
| Japan |
Condition
Condition
Graves' disease
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the effect of inactive iodine and lithium carbonate in radioiodine therapy of Graves' disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Proportion of patients who achieved an euthyroid or hypothyroid at 24 weeks after radioiodine therapy : free T4 level of less than upper limit of normal
Key secondary outcomes
Proportion of patients who achieved an euthyroid or hypothyroid at 24 weeks after radioiodine therapy : free T3 level of less than upper limit of normal and TSH level of more than lower limit of normal.
Changes in thyroid volume from 0 to 1 and 24 weeks.
Incidence and evaluation of adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Only radioiodine therapy
Interventions/Control_2
Radioiodine therapy and inactive iodine 0.1 mg tid for 5 days
Interventions/Control_3
Radioiodine therapy and lithium carbonate 600 mg tid for 8 days
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Graves' disease according to the guideline of the Japan Thyroid Association
Patient who hoped for radioiodine treatment after enough explanation about risk and benefit of this therapy.
Age>=19 years old when the consent is obtained.
Possible to attend a hospital regularly about 24 weeks.
No previous radioiodine therapy.
Possible to obtain written informed consent.
Key exclusion criteria
Pregnancy, suspected pregnancy or who won't avoid pregnancy within one year.
Nursing woman (possible when not nursing).
Active Graves' ophthalmopathy (CAS ) or deterioration in eye symptoms in the preceding months
Contraindication of inactive iodine and lithium carbonate.
Any other reason for which the investigator judged the patient to be unfit for study.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuhei Nakanishi |
Organization
Hiroshima University
Division name
Department of Molecular and Internal Medicine
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima-City, Hiroshima 734-8551, Japan
TEL
082-257-5196
atori@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Oki |
Organization
Hiroshima University
Division name
Department of Molecular and Internal Medicine
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima-City, Hiroshima 734-8551, Japan
TEL
082-257-5196
Homepage URL
kenji-oki@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital Department of Endocrinology and Metabolism
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
広島大学病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 03 | Month | 19 | 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
Terminated
Date of protocol fixation
| 2008 | Year | 01 | Month | 08 | Day |
Date of IRB
| 2008 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2008 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Additional study:
The effect of a decrease of the thyroid volume by first time radiation therapy on additional radioiodine therapy
Management information
Registered date
| 2008 | Year | 03 | Month | 19 | Day |
Last modified on
| 2019 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001319
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
