UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016040 |
|---|---|
| Receipt number | R000018645 |
| Scientific Title | Radioiodine Therapy Associated Exacerbation of Initially Inactive or Absent Graves' Ophthalmopathy: A Prospective Study in the Japanese Population: Is Low Dose Prednisolone Effective for Prevention? |
| Date of disclosure of the study information | 2014/12/25 |
| Last modified on | 2014/12/24 10:30:00 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Radioiodine Therapy Associated Exacerbation of Initially Inactive or Absent Graves' Ophthalmopathy: A Prospective Study in the Japanese Population: Is Low Dose Prednisolone Effective for Prevention?
Acronym
Graves' Ophthalmopathy After Radioiodine Therapy
Scientific Title
Radioiodine Therapy Associated Exacerbation of Initially Inactive or Absent Graves' Ophthalmopathy: A Prospective Study in the Japanese Population: Is Low Dose Prednisolone Effective for Prevention?
Scientific Title:Acronym
Graves' Ophthalmopathy After Radioiodine Therapy
Region
| Japan |
Condition
Condition
Graves' disese
Classification by specialty
| Endocrinology and Metabolism | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To describe the characteristics of the exacerbation of GO after RIT and examine the effectiveness of low-dose prednisone (PSL) prophylaxis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Outcomes of GO 1 year after RIT
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Intervention:Graves' disease with steroid prophylaxis for 6 weeks.In the PSL-On group, patients were initially given 15 mg per day of PSL, with the daily dose then reduced by 5 mg every 2 weeks for a cumulative 420 mg dose. Treatment was started on the day of RIT and lasted 6 weeks.
Interventions/Control_2
Control: Graves' disease without steroid prophylaxis.
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
| 18 | years-old | < |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Graves' disease with inactive or without GO
Key exclusion criteria
1) active GO and/ or a past history of treatment for GO
2) concomitant disease: diabetes mellitus, gastric ulcer, glaucoma, heart failure, hepatitis C, old age, and steroid treatment for other disease
Target sample size
133
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
n-watanabe@ito-hospital.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Natsuko Watanabe |
Organization
Ito Hospital
Division name
Internal medicine
Zip code
Address
4-3-6 Jingumae, Shibuya-ku, Tokyo, Japan
TEL
03-3402-7411
Homepage URL
n-watanabe@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
Ito Hospital(Tokyo), Olympia Eye Hospital(Tokyo)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 25 | 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
| 2011 | Year | 05 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 22 | 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
| 2014 | Year | 12 | Month | 24 | Day |
Last modified on
| 2014 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018645
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
