A Prospective, Non-Intervention, Multi-Center Observational Study to Evaluate the Efficacy and Safety of FEXUCLUE Tablet in Patients With Erosive Gastroesophageal Reflux Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9,846
- 试验地点
- 1
- 主要终点
- Change in the average score of the degree of individual symptoms of subjective symptoms (RDQ)
研究概览
简要总结
This observational study is a large-scale, prospective, and multi-institutional observational study.
Patients from 19 to 75 years of age, will take a self-assessment (PRO) during the study period before and after administration of Pexuclue tablet.
详细描述
Data will be collected based on patient's medical records from daily visit. Enrolled subjects will take a Patient Reported Outcome (PRO) survey including Quality of life evaluation (GERD-HRQL) and self-awareness symptom (RDQ).
The survey will be done twice (before and after the administration of Fexuclue tablet) electronically through an application (e-PRO).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult aged 19 years to 75 years (on registration date)
- •Patient scheduled to administer Fexuclue tablet based on the medical judgment of investigator.
- •Patient who has not taken a treatment for gastroesophageal reflux disease within two weeks from baseline visit.
- •Patient who agreed to participate in this observation study and signed Informed Consent Form
排除标准
- •A person who falls under the prohibition of administration according to the permission for Fexuclue Tablet
- •Patients with hypersensitivity to the components of Fexuclue tablet or Fexuclue tablet and a history thereof
- •Patients undergoing Atazanavir, Nelfinavir or Lilpivirin-containing preparations
- •Pregnant and lactating women
- •Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabortion
- •A person who has taken a treatment for gastroesophageal reflux disease within two weeks from baseline visit.
- •In addition to the above, a person who has determined that the researcher (the doctor in charge) is not suitable for participation in this observation study
结局指标
主要结局
Change in the average score of the degree of individual symptoms of subjective symptoms (RDQ)
时间窗: at least 4 weeks (up to 8 weeks)
Average score change in Reflux Disease Questionnaire (0 \~5) from baseline
Change in the average score of the frequency of individual symptoms of subjective symptoms (RDQ)
时间窗: at least 4 weeks (up to 8 weeks)
Average score change in Reflux Disease Questionnaire (0 \~5) from baseline
次要结局
- RDQ validity rate(at least 4 weeks (up to 8 weeks))
- RDQ loss rate(at least 4 weeks (up to 8 weeks))
- Quality of Life (GERD-HRQL) Total score change(at least 4 weeks (up to 8 weeks))
- Changes in average score of the degree by symptoms (reflux, heartburn, indigestion)(at least 4 weeks (up to 8 weeks))
- Overall improvement evaluated by the subjects(at least 4 weeks (up to 8 weeks))
- Overall improvement evaluated by the researchers(at least 4 weeks (up to 8 weeks))
- Changes in average score of the frequency by symptoms (reflux, heartburn, indigestion)(at least 4 weeks (up to 8 weeks))