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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004237
Receipt No. 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

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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
Email 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
Email m.tomiita@gmail.com

Sponsor
Institute Graduate School of Medicine, Chiba University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004933

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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