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

Phase 2

Completed

• Conditions: Xerostomia; Sjogren's Syndrome

• Registration Number: NCT00233363
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief Summary

The purpose of this study is to exploratively investigate the clinical efficacy of rebamipide on dry mouth in patients with Sjögren's syndrome in comparison with placebo.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04-15
• Study First Submitted: 2005-10-04
• Study First Submitted QC: 2005-10-04
• Study First Posted: 2005-10-05
• Primary Completion: 2006-01-19
• Study Completion: 2006-01-27
• Status Verified: 2021-05
• Results First Submitted: 2021-05-11
• Results First Submitted QC: 2021-05-11
• Last Update Submitted: 2021-05-11
• Results First Posted: 2021-06-04
• Last Update Posted: 2021-06-04

Recruitment & Eligibility

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

Inclusion Criteria

1. Patients with Sjögren's syndrome (Revised Japanese criteria for Sjögren's syndrome (1999): 1998 research report on immunological intractable diseases specified by the Japanese Ministry of Health and Welfare)
2. Patients aged 20 years or older at time of consent
3. Patients with dry mouth
4. Patients with decreased salivation

Exclusion Criteria

1. Patients who have developed dry mouth clearly due to a cause other than Sjögren'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: PARALLEL

Primary Outcome Measures

Name	Time	Method
Overall Improvement Rate in Dry Mouth Symptoms	Weeks 2, 4, and 8	At visits to the study site at two, four, and eight weeks after the start of administration, subjects self-assessed the overall change in their dry mouth symptoms in comparison with their symptoms before the start of treatment on the following four-grade scale: (1) Markedly improved (clearly better), (2) Improved (better) , (3) Unchanged (almost no difference), and (4) Aggravated (worse).; The improvement rate was calculated by defining improvement as an assessment of either (1) Markedly improved or (2) Improved.

Trial Locations

Locations (1)

Otsuka Pharmaceutical Co., Ltd.; 🇯🇵 Tokyo, Japan