JPRN-jRCT2080220036已完成2 期
Exploratory study of rebamipide to evaluate the efficacy and safety in treatment of dry mouth in patients with Sjogren's syndrome
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 104
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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