UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021482 |
|---|---|
| Receipt number | R000024780 |
| Scientific Title | Prospective study on the efficacy of intravenous glucocorticoid therapy in Japanese patients with Graves' ophthalmopathy. |
| Date of disclosure of the study information | 2016/03/15 |
| Last modified on | 2016/03/15 20:43:56 |
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Basic information
Public title
Prospective study on the efficacy of intravenous glucocorticoid therapy in Japanese patients with Graves' ophthalmopathy.
Acronym
Steroid pulse therapy for Graves' ophthalmopathy
Scientific Title
Prospective study on the efficacy of intravenous glucocorticoid therapy in Japanese patients with Graves' ophthalmopathy.
Scientific Title:Acronym
Steroid pulse therapy for Graves' ophthalmopathy
Region
| Japan |
Condition
Condition
Graves' ophthalmopathy
(Active, and moderate, severe or sight threatening type)
Classification by specialty
| Endocrinology and Metabolism | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of dose of invravenous glucocorticoid in efficacy and safety for Graves' ophthalmopathy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Efficacy: ophthalmological signs 1, 3, 6 and 12 months after pulse therapy.
Key secondary outcomes
Efficacy: CAS and MRI findings 1, 3, 6 and 12 months after pulse therapy.
Safety: liver function test, glucose intolerance, peptic ulcer, psychiatric symptoms during and 1, 3, 6, 12 months after pulse therapy.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
GO patients were randomly divided two groups. One group received 1.0g of methylprednisolone intravenously for 3 successive days and repeated every week up to 3 cycles.
Interventions/Control_2
The other group received 0.5g of methylprednisolone intravenously for 3 successive days and repeated every week up to 3 cycles.
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
| 35 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with active and moderate, severe, sight threatening Graves' ophthalmopathy (GO). The activity of GO was assessed by CAS (more than 3 scores) or MRI.
Key exclusion criteria
Hepatitis B virus infection (carrier or HBcAb positive)
Hepatitis C virus infection (HCVAb positive)
Severe hypertension, heart disease, Psychiatric disease,
HbA1c>8.0%
Active tuberculosis
Pregnancy
Lactation
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Hiromatsu |
Organization
Kurume University Medical Center
Division name
Division of Endocrinology and Metabolism
Zip code
Address
155-1 Kokubumachi, Kurume, Fukuoka, 839-0863 Japan
TEL
0942-22-6111
yuji@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuji Hiromatsu |
Organization
Kurume University Medical Center
Division name
Division of Endocrinology and Metabolism
Zip code
Address
155-1 Kokubumachi, Kurume, Fukuoka, 839-0863 Japan
TEL
0942-22-6111
Homepage URL
yuji@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University Medical Center
Institute
Department
Personal name
Funding Source
Organization
MHLW(Japan)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
久留米大学医療センター （福岡県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 15 | 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 | 03 | Month | 15 | Day |
Last modified on
| 2016 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024780
