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

Sjogren's Syndrome Clinical Trial

Official title:

An Exploratory Study of Rebamipide to Evaluate Efficacy and Safety in the Treatment of Dry Mouth in Patients With Sjögren's Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00233363
• Other study ID #: 037-04-001
• Secondary ID: JapicCTI-050036
• Status: Completed
• Phase: Phase 2
• Start date: April 15, 2005
• Est. completion date: January 27, 2006

Study information

• Verified date: May 2021
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: January 27, 2006
• Est. primary completion date: January 19, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sjogren's Syndrome
• Syndrome
• Xerostomia

Intervention

Drug:
• Rebamipide

Locations

Country	Name	City	State
Japan	Otsuka Pharmaceutical Co., Ltd.	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Improvement Rate in Dry Mouth Symptoms	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.	Weeks 2, 4, and 8