A Multi-center Prospective Observational Study to Evaluate the Effectiveness and Safety of JAQBO® Tab. 20 mg(Zastaprazan Citrate) in Erosive Gastroesophageal Reflux Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 7,150
- 主要终点
- Change in Reflux Disease Questionnaire (RDQ) at Week 8
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and safety of JAQBO® Tab. 20 mg(Zastaprazan citrate) patients who have been prescribed the investigational drug.
详细描述
Multi-center prospective observational study
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 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 aged 19 years or older who have been diagnosed with erosive reflux disease (ERD)
- •subjects who have voluntarily decided to participate in this observational study and have provided written informed consent after receiving the study information and consent form
排除标准
- •Subjects who fall under the contraindications listed in the precautions for use section of the approved labeling for Fexuclu tablets:
- •Subjects with hypersensitivity or a history of hypersensitivity to the investigational drug or any of its components
- •Subjects currently taking medications containing atazanavir, nelfinavir, or rilpivirine
- •Pregnant women, women who may be pregnant, or breastfeeding women
- •Subjects with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- •Subjects deemed inappropriate for participation in the study at the investigator's discretion.
结局指标
主要结局
Change in Reflux Disease Questionnaire (RDQ) at Week 8
时间窗: Week 8
This questionnaire is a self-reported instrument designed to assess the main symptoms of gastroesophageal reflux disease (GERD), including heartburn, acid regurgitation, and dyspepsia. It consists of a total of 12 items, each evaluating the frequency and severity of symptoms using a 6-point scale (0 to 5). In this observational study, only heartburn and acid regurgitation symptoms are assessed. The questionnaire is completed by the study participants themselves, and higher total scores indicate more severe symptoms.
次要结局
未报告次要终点