UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004162
Receipt number R000004987
Scientific Title The efficacy of Mizoribine for scleroderma of systemic sclerosis.
Date of disclosure of the study information 2010/09/05
Last modified on 2015/01/22 13:48:38

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Basic information

Public title

The efficacy of Mizoribine for scleroderma of systemic sclerosis.

Acronym

The efficacy of Mizoribine for scleroderma of systemic sclerosis.

Scientific Title

The efficacy of Mizoribine for scleroderma of systemic sclerosis.

Scientific Title:Acronym

The efficacy of Mizoribine for scleroderma of systemic sclerosis.

Region

Japan


Condition

Condition

systemic sclerosis

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The efficacy of Mizoribine for scleroderma is compared to the existing treatment by steroid.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

skin screlosis

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

a group of Mizoribine

Interventions/Control_2

a group of the existing treatment

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The cases of severe systemic screlosis and intractable skin screlosis by the existing treatment.

Key exclusion criteria

The cases of hypersensitivity for Mizoribine.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hironobu Ihn

Organization

Faculty of Life Sciences, Kumamoto University

Division name

Department of Dermatology and Plastic Surgery

Zip code


Address

1-1-1 Honjo Kumamoto city

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Takamitsu Makino

Organization

Faculty of Life Sciences, Kumamoto University

Division name

Department of Dermatology and Plastic Surgery

Zip code


Address

1-1-1 Honjo Kumamoto city

TEL


Homepage URL


Email



Sponsor or person

Institute

Faculty of Life Sciences, Kumamoto University

Institute

Department

Personal name



Funding Source

Organization

No

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2010 Year 09 Month 05 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

2010 Year 08 Month 17 Day

Date of IRB


Anticipated trial start date

2010 Year 09 Month 01 Day

Last follow-up date

2014 Year 11 Month 30 Day

Date of closure to data entry

2014 Year 12 Month 31 Day

Date trial data considered complete

2014 Year 12 Month 31 Day

Date analysis concluded

2014 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2010 Year 09 Month 05 Day

Last modified on

2015 Year 01 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004987


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name