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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001087
Receipt No. 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

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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
Email 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
Email kenji-oki@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University Hospital Department of Endocrinology and Metabolism
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001319

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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