Unique ID issued by UMIN | UMIN000004237 |
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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 |
Efficacy and safety of mizoribine for patients with Sjogren's syndrome in pediatric age
Mizoribine for Sjogren's syndrome in pediatric age
Efficacy and safety of mizoribine for patients with Sjogren's syndrome in pediatric age
Mizoribine for Sjogren's syndrome in pediatric age
Japan |
Sjogren's syndrome in pediatric age
Clinical immunology | Pediatrics |
Others
NO
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.
Safety,Efficacy
Confirmatory
Phase II
Change of saliva production
Change of data of laboratory examinations
Change of salivary function, change of subjective symptoms, change of data of laboratory examinations, gastrointestinal symptoms
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Mizoribine 10 mg/kg (up to 500 mg) will be administered once daily twice a week.
10 | years-old | <= |
20 | years-old | > |
Male and Female
Patients with primary Sjogren's syndrome fulfill the revised diagnostic criteria for Sjogren's syndrome of the Ministry of Health and Welfare (1999)
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
5
1st name | |
Middle name | |
Last name | Takayasu Arima |
Graduate School of Medicine, Chiba University
Department of Pediatrics
1-8-1 Inohana, Chuo-ku, Chiba city
043-226-2144
tarima@faculty.chiba-u.jp
1st name | |
Middle name | |
Last name | Minako Tomiita |
Graduate School of Medicine, Chiba Universitity
Department of Pediatrics
1-8-1 Inohana, Chuo-ku, Chiba city
043-226-2144
m.tomiita@gmail.com
Graduate School of Medicine, Chiba University
none
Self funding
NO
2010 | Year | 09 | Month | 19 | Day |
Partially published
Completed
2010 | Year | 07 | Month | 20 | Day |
2013 | Year | 03 | Month | 31 | Day |
2014 | Year | 05 | Month | 22 | Day |
2015 | Year | 03 | Month | 31 | Day |
2015 | Year | 03 | Month | 31 | Day |
2015 | Year | 03 | Month | 31 | Day |
2010 | Year | 09 | Month | 19 | Day |
2015 | Year | 03 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004933
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