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

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000001460
• Date of registration: 29/10/2008
• Prospective Registration: No
• Primary sponsor: Department of Pediatrics, Graduate School of Medicine, Chiba Univerity
• Public title: The efficacy and safety of pirocarpine hydrochloride for juvenile Sjogren's syndrome
• Scientific title: The efficacy and safety of pirocarpine hydrochloride for juvenile Sjogren's syndrome - Efficacy of pirocarpine for juvenile SS
• Date of first enrolment: 2008/10/01
• Target sample size: 10
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001776
• Study type: Interventional
• Study design: Single arm Non-randomized
• Phase: Not selected

Countries of recruitment

Japan

Contacts

• Name: MINAKO TOMIITA
• Affiliation: Chiba University Graduate School of Medicine, Department of Pediatrics

• Name: MINAKO TOMIITA
• Affiliation: Chiba University Graduate School of Medicine, Department of Pediatrics

Key inclusion & exclusion criteria

Inclusion 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

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

Health Condition(s) or Problem(s) studied

Sjogren's syndrome

Intervention(s)

Oral pilocarpine hydrochloride for 4 weeks.

Primary Outcome(s)

Change of salivary production, change of pulse rate and blood pressure

Secondary Outcome(s)

Change of oral symptoms: oral abnormality, cracker sign, abnormal feeling of oral cavity at morning, mouth odor, total water intake, xerostomia.

Source(s) of Monetary Support

none

Ethics review

Status: YES
Approval date:
Contact:

Results

• Results available: Yes
• Date Completed: 01/07/2009