A Multi-center, Prospective, Observational Study to Evaluate the Safety and Efficacy of K-CAB Tab./K-CAB ODT(Tegoprazan) in GERD Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,384
- 试验地点
- 1
- 主要终点
- Symptom improvement rate at 4 weeks after administration of K-CAB Tablet/K-CAB ODT.
研究概览
简要总结
This study aims to evaluate the status of AE and improvement effect of K-CAB Tab/K-CAB ODT(Tegoprazan) 50mg in patients with GERD.
详细描述
This is a multi-center, prospective, non-interventional, observational study. Subjects will be prescribed in one of the two formulation groups (K-CAB Tab 50 mg or K-CAB ODT 50 mg).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects over 19 years of age as of the date of consent
- •Subjects with a total score of 8 or more in the Korean Gastroesophageal Reflux Disease Questionnaire (GerdQ) based on Visit 1
- •Subjects who voluntarily decides to participate and agrees in writing to the consent form of the study
排除标准
- •Subjects who have hypersensitivity reactions and a medical history of Benzimidazole or components of the investigational drug
- •Subjects on Atazanavir, Nelfinavir, or Rilpivirine-containing medications
- •Pregnant and lactating women
结局指标
主要结局
Symptom improvement rate at 4 weeks after administration of K-CAB Tablet/K-CAB ODT.
时间窗: From enrollment to the end of treatment at 4 weeks. If symptoms do not disappear at the time of 4 weeks, F/U is added for an additional 4 weeks.
After administering the K-CAB Tablet/K-CAB ODT for 4 weeks, heartburn and gastric acid reflux symptoms are evaluated using the symptom evaluation score, and the proportion of subjects whose sum of symptom evaluation scores has improved by more than 50%(50% Overall Responder).
次要结局
未报告次要终点