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

JRCT ID: jRCT2080220036

Registered date:06/09/2005

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Dry mouth in patients with Sjogren's syndrome
• Date of first enrollment: 15/04/2005
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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

control material(s)
Generic name etc : Placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Oral

Outcome(s)

Primary Outcome

safety
efficacy
Efficacy/safety

• Secondary Outcome: -

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Secondary Sponsor: -
• Source(s) of Monetary Support: -
• Secondary ID(s): NCT00233363,JapicCTI-050036