The efficacy and safety of pirocarpine hydrochloride for juvenile Sjogren's syndrome

UMIN ID: UMIN000001460

Registered date:29/10/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Sjogren's syndrome
• Date of first enrollment: 2008/10/01
• Target sample size: 10
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Oral pilocarpine hydrochloride for 4 weeks.

Outcome(s)

• Primary Outcome: Change of salivary production, change of pulse rate and blood pressure
• Secondary Outcome: Change of oral symptoms: oral abnormality, cracker sign, abnormal feeling of oral cavity at morning, mouth odor, total water intake, xerostomia.

Key inclusion & exclusion criteria

• Age minimum: 6years-old
• Age maximum: 16years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Department of Pediatrics, Graduate School of Medicine, Chiba Univerity
• Source(s) of Monetary Support: none