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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name