Systemic Sclerosis
Conditions
Interventions
Take three tablets after meal three times a day (9 tablets/day) for 24 weeks. The number of tablets can be reduced to one tablet after meal two times a day (2 tablets/day) based on the age, body weigh
Sponsors
The University of Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)systemic sclerosis patients (Ministry of Health, Labor and Welfare Japan, diagnostic criteria 2016) 2)Patients whose age ranges from 20 years to under 80 when acquiring consent 3)After receiving sufficient explanation for the participation of this study, patients who obtained document consent by the patient's free will with sufficient understanding
Exclusion criteria
Exclusion criteria: 1)Patients with aldosteronism, myopathy or hypokalemia 2)Patients with cirrhosis with more than 70 microgram/dL serum ammonia concentration 3)Patients less than 3 months after the final administration of the other test drugs or investigational drugs 4)Patients with more than 10 MRSS (modified Rodnan total skin thickness score) 5)Patients with not satisfy% VC 80% and % DLCO 70% in respiratory function test 6)Patients with eGFR less than 45 mL / min / 1.73 m2 7)Patients with more than RVSP>40mmHg pulmonary hypertension 8)Patients with complications of systemic lupus erythematosus or dermatomyositis 9)Patients with a history of malignant tumors 10)Patients with a history of severe hypersensitivity or anaphylactic reaction to the components of test drug 11)patient judged by doctor as inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of capillary vessels per unit length of posterior fingernail counted every 4 weeks from the start of administration | — |
Secondary
| Measure | Time frame |
|---|---|
| every 4 weeks from the start of administration 1.Number of enlarged or disarrangement capillary vessels or avascular areas per unit length of posterior fingernail counted every 4 weeks from the start of administration 2.Raynaud score 3.Health Assessment Questionnaire score 4.modified Rodnan total skin thickness score 5.Presence or absence of new ulcer on finger | — |
Countries
Japan
Contacts
Public ContactHAYAKAZU SUMIDA
The University of Tokyo Hospital Dermatology
Outcome results
None listed