UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004237 |
|---|---|
| Receipt number | R000004933 |
| Scientific Title | Efficacy and safety of mizoribine for patients with Sjogren's syndrome in pediatric age |
| Date of disclosure of the study information | 2010/09/19 |
| Last modified on | 2015/03/19 11:51:26 |
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Basic information
Public title
Efficacy and safety of mizoribine for patients with Sjogren's syndrome in pediatric age
Acronym
Mizoribine for Sjogren's syndrome in pediatric age
Scientific Title
Efficacy and safety of mizoribine for patients with Sjogren's syndrome in pediatric age
Scientific Title:Acronym
Mizoribine for Sjogren's syndrome in pediatric age
Region
| Japan |
Condition
Condition
Sjogren's syndrome in pediatric age
Classification by specialty
| Clinical immunology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Mizoribine improved salivary flow volume and subjective symptoms in adult Sjogren's syndrome. In this study, we will evaluate the efficacy and safety of mizoribine for pediatric patients with Sjogren's syndrome.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Change of saliva production
Change of data of laboratory examinations
Key secondary outcomes
Change of salivary function, change of subjective symptoms, change of data of laboratory examinations, gastrointestinal symptoms
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Mizoribine 10 mg/kg (up to 500 mg) will be administered once daily twice a week.
Interventions/Control_2
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
| 10 | years-old | <= |
Age-upper limit
| 20 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with primary Sjogren's syndrome fulfill the revised diagnostic criteria for Sjogren's syndrome of the Ministry of Health and Welfare (1999)
Key exclusion criteria
1. Patients with a history of mizoribine use
2. Patients with a white blood cell count of not more than 3,000 / mm3
3. Pregnant women or women who may become pregnant and women who wish to become pregnant during the course of the study
4. Patients who used cevimeline hydrochloride hydrate, pilocarpine hydrochloride and anetholtrithion within the 4 week period before the start of the study
5. Patients using other immunosuppressive drugs and anti-rheumatoid drugs
6. Other patients who were judged to be ineligible for the study by an attending physician
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayasu Arima |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Pediatrics
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba city
TEL
043-226-2144
tarima@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Minako Tomiita |
Organization
Graduate School of Medicine, Chiba Universitity
Division name
Department of Pediatrics
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba city
TEL
043-226-2144
Homepage URL
m.tomiita@gmail.com
Sponsor or person
Institute
Graduate School of Medicine, Chiba University
Institute
Department
Personal name
Funding Source
Organization
none
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 09 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2010 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2014 | Year | 05 | Month | 22 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 09 | Month | 19 | Day |
Last modified on
| 2015 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004933
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
