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

Phase 2

Completed

• Conditions: Dry mouth in patients with Sjogren's syndrome

• Registration Number: JPRN-jRCT2080220036
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief Summary

With the ability to moderately increase salivation and a good safety profile in patients with Sjogren's syndrome, rebamipide appears to be a promising treatment for dry mouth symptoms in these patients.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-06
• Study Completion: 2006-01-19
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 104

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety<br>efficacy<br>Efficacy/safety