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
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
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
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
