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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000004237 |
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Date of registration:
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19/09/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy and safety of mizoribine for patients with Sjogren's syndrome in pediatric age
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Scientific title:
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Efficacy and safety of mizoribine for patients with Sjogren's syndrome in pediatric age - Mizoribine for Sjogren's syndrome in pediatric age |
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Date of first enrolment:
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2013/03/31 |
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Target sample size:
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5 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004933 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Phase II
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Countries of recruitment
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Japan
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Contacts
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Name:
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Minako Tomiita |
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Address:
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1-8-1 Inohana, Chuo-ku, Chiba city
Japan |
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Telephone:
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043-226-2144 |
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Email:
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m.tomiita@gmail.com |
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Affiliation:
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Graduate School of Medicine, Chiba Universitity Department of Pediatrics |
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Name:
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Takayasu Arima |
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Address:
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1-8-1 Inohana, Chuo-ku, Chiba city
Japan |
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Telephone:
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043-226-2144 |
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Email:
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tarima@faculty.chiba-u.jp |
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Affiliation:
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Graduate School of Medicine, Chiba University Department of Pediatrics |
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Key inclusion & exclusion criteria
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Inclusion criteria:
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
Age minimum:
10years-old
Age maximum:
20years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Sjogren's syndrome in pediatric age
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Intervention(s)
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Mizoribine 10 mg/kg (up to 500 mg) will be administered once daily twice a week.
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Primary Outcome(s)
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Change of saliva production Change of data of laboratory examinations
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Secondary Outcome(s)
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Change of salivary function, change of subjective symptoms, change of data of laboratory examinations, gastrointestinal symptoms
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Source(s) of Monetary Support
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none
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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22/05/2014 |
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URL:
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