Sjogren'
Conditions
Interventions
Pilocarpine / sodium alginate solution (0.32 mL, pilocarpine 0.96 mg) is administered intra-orally 3 times a day for 7 days.
Sponsors
Teikyo University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosed as Sjogren's syndrome 2. Aged 16 years-old or more 3. With Salivary flow lower than 2 grams or less per 2 minutes 4. Having symptoms of oral dryness 5. Having submitted written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with ischemic heart disease 2. Patients with asthma or chronic obstructive airway disease 3. Patients with gastrointestinal obstruction or bladder neck obstruction 4. Patients with epilepsy 5. Patients with parkinsonism or Parkinson's disease 6. Patients with iritis 7. Patients with hypersensitivity on pilocarpine or arginine 8. Patients administered with pilocarpine hydrochloride within 6.5 hours 9. Patients administered with cevimeline hydrochloride hydrate within 20 hours 10. Patients administered with anetholtrithion within 9.5 hours 11. Patients judged by a physician to be inappropriate for inclusion in the study for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Salivary flow before and 60 minutes after administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjective symptom of oral dryness Adverse events | — |
Countries
Japan
Contacts
Public ContactMachiko Watanabe
Teikyo University Faculty of Pharma-Science
Outcome results
None listed