Exploratory Study for Dry Mouth in Patients With Sjogren's Syndrome

Exploratory study of rebamipide to evaluate the efficacy and safety in treatment of dry mouth in patients with Sjogren's syndrome

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080220036

Enrollment

100

Registered

2005-09-06

Start date

2005-04-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry mouth in patients with Sjogren's syndrome

Interventions

investigational material(s) Generic name etc : Rebamipide INN of investigational material : Rebamipide Therapeutic category code : 226 Gargles Dosage and Administration for Investigational material :

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with Sjogren's syndrome, 2) patients with dry mouth, 3) patients with decreased salivation, 4) patients aged 20 years or older at time of consent

Exclusion criteria

Exclusion criteria: 1. Patients who have developed dry mouth clearly due to a cause other than Sjogren's syndrome 2. Patients in whom Saxon test cannot be performed (artificial tooth, tooth implant, etc.) 3. Patients who have received rebamipide within 3 months prior to obtaining informed consent 4. Patients who are pregnant, possibly pregnant, or lactating 5. Patients with a history of hypersensitivity to rebamipide 6. Patients who have received any other investigational drug within 3 months prior to obtaining informed consent 7. Patients who are otherwise judged inappropriate for inclusion in the study by the investigator or subinvestigator

Design outcomes

Primary

Measure	Time frame
safety efficacy Efficacy/safety	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026