KCT0001704尚未招募未知
A Multicenter, Randomized, Double-blind, Placebo-controlled Dose-finding Phase 2 Trial to Evaluate the Efficacy and Safety of YH12852 in Patients with Functional Dyspepsia
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- Yuhan
- 入组人数
- 420
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •Subjects must be willing to and able to provide written informed consent.
- •- Patients experiencing one or more of the following symptom(s): early satiation, postprandial fullness, upper abdominal discomfort and upper abdominal pain beginning at least 6 months prior according to Rome III criteria, with the symptom(s) evident over the last 3 months at the time of screening.
- •- Patients with no evidence of organic lesions based on upper GI(gastrointestinal) endoscopy, which could be the cause of dyspeptic symptoms
- •- Body mass index (BMI) of < 35 kg/m2 at screening.
- •- Men and women aged 19 years and older
排除标准
- •- Patients with organic lesions (GERD(gastroesophageal reflux disease) ; =LA Grade A, erosion, ulcer, hiatal hernia, bleeding, malignancy or Barrett’s esophagus, etc.) based on upper GI endoscopy
- •- Subjects with a history of surgery that could affect gastrointestinal motility
- •- Women who are pregnant or breastfeeding.
- •- History of malignancy (unless there has been no reoccurrence of the disease for = 10 years, or the tumor is confined as a basal carcinoma in situ).
- •- Subjects who are deemed unsuitable, in the investigator’s opinion, to participate in the study for other reasons (any condition which in the investigator’s opinion may render the subject unable to complete the study or which may pose a significant risk to the subject.)
研究者
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