An Exploratory Study of Rebamipide to Evaluate Efficacy and Safety in the Treatment of Dry Mouth in Patients With Sjögren's Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Overall Improvement Rate in Dry Mouth Symptoms
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
- •Patients aged 20 years or older at time of consent
- •Patients with dry mouth
- •Patients with decreased salivation
排除标准
- •Patients who have developed dry mouth clearly due to a cause other than Sjögren's syndrome
- •Patients in whom Saxon test cannot be performed (artificial tooth, tooth implant, etc.)
- •Patients who have received rebamipide within 3 months prior to obtaining informed consent
- •Patients who are pregnant, possibly pregnant, or lactating
- •Patients with a history of hypersensitivity to rebamipide
- •Patients who have received any other investigational drug within 3 months prior to obtaining informed consent
- •Patients who are otherwise judged inappropriate for inclusion in the study by the investigator or subinvestigator
结局指标
主要结局
Overall Improvement Rate in Dry Mouth Symptoms
时间窗: 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.
次要结局
未报告次要终点