Sjogren'
Conditions
Interventions
Oral pilocarpine hydrochloride for 4 weeks.
Sponsors
Department of Pediatrics, Graduate School of Medicine, Chiba Univerity
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who are diagnosed as Sjogren's syndrome and met all of following inclusion criteria. 1) Patients who are 6~16 years of age and can provide the written informed consent. 2) Patients who have mouth abnormality including dryness of mouth 3) Patients who can discontinue use of any prohibited medication at least 14 days prior to admission to the study 4) Patients who can discontinue use of any medication requiring careful administration at least 14 days prior to admission to the study, if they discontinue them. 5) Patients who can be treated as outpatients throughout the study. 6) Patients who can undergo Saxon test.
Exclusion criteria
Exclusion criteria: Patients who fulfills any of following exclusion criteria will be excluded. 1) Secondary Sjogren's syndrome 2) Hypersensitivity to pilocarpine HCl or cevimeline HCl 3) Iritis 4) A condition predisposing to retinal detachment including having retinal breaks or history of retinal breaks 5) Serious gallbladder disease, biliary disease or biliary obstruction 6) Serious nephrolithiasis or ureterolithiasis 7) Bronchial asthma, chronic obstructive lung disease or interstitial pneumonia 8) Gastrointestinal obstruction or bladder neck obstruction 9) Epilepsy 10) Serious cardiac disease including ischemic heart disease, serious arrhythmia, cardiomyopathy or myocarditis 11) Serious vascular disease including aortic aneurysm, aortic dissection 12) Serious cerebrovascular disorder including brain hemorrhage after surgery, stroke, or aortic dissection 13) Serious hepatic disorder including fulminant hepatitis, hepatic cirrhosis, hepatic tumor or total bilirubin level 3.0mg/dL or higher or AST(GOT) or ALT(GPT) of at least 2.5 fold higher than the upper standard limit 14) Serious renal disease including nephritic syndrome, acute nephropathy, acute nephritis, chronic nephritis or serum creatinine level 1.5mg/dL or higher 15) Serious blood disease or hematopoietic system disorder 16) Patients who are considered ineligible for participation in the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of salivary production, change of pulse rate and blood pressure | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of oral symptoms: oral abnormality, cracker sign, abnormal feeling of oral cavity at morning, mouth odor, total water intake, xerostomia. | — |
Countries
Japan
Contacts
Public ContactMINAKO TOMIITA
Chiba University Graduate School of Medicine, Department of Pediatrics
Outcome results
None listed