JPRN-jRCT2080220390已完成2 期
An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 124
研究概览
简要总结
Clinical improvement rate, the primary endpoint, in the rebamipide 60-mg, 150-mg, and 300-mg groups was respectively 31.4%, 24.1%, and 44.4% versus 30.0% in the placebo group. This result showed no evident efficacy or dose-dependency for rebamipide within the dose range of up to 300 mg. No particular safety concerns emerged at any dose studied.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 16age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1)Patients aged 16 years or older
- •2)Patients having an insufficient response to ASA oral formulation
- •3)Patients shown via colonoscopy to have major lesions between the sigmoid colon and rectum
排除标准
- •1. Patients who have a history of intestinal resection (other than appendiceal resection)
- •2. Patients who have a complication of malignant tumor
- •3. Female patients who are pregnant, lactating, or possibly pregnant, or who hope to become pregnant during the study period
- •4. Patients who have complications of serious cardiac, hepatic or renal impairment
研究者
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