A Multi-Center, Prospective, Observational Study to Evaluate the Improvement Effect on Subjective Symptom of FEXUCLUE Tab. 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
- 2,852
- 试验地点
- 1
- 主要终点
- Average score change in RDQ
研究概览
简要总结
This observation study is a large-scale, prospective, and multi-organ observation study to observe the improvement effect of the self-evaluation results (PRO) of erosive gastroesophageal reflux disease at least 4 to 8 weeks after administration of Fexuclue Tab.
详细描述
This observation study is a large-scale, prospective, and multi-organ observation study to observe the improvement effect of the self-evaluation results (PRO) of erosive gastroesophageal reflux disease at least 4 to 8 weeks after administration of Fexuclue Tab.
Subjects who met the inclusion/exclusion criteria will administer Fexuclue Tablet once a day for four weeks after registration, regardless of their meals. If esophagitis is not treated or symptoms continue after 4 weeks of administration, the subject will continue to administer Fexuclue Tablet for 4 more weeks (maximum administration period: 8 weeks).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult men and women aged 19 to 75 years of age at the time of registration.
- •A patient with erosive gastroesophageal reflux disease who is scheduled to administer Fexuclue Tab. for the first time based on the medical judgement of the researcher based on the medication authorization.
- •A person who voluntarily agrees to participate in this observation study and signed the 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 participates in another clinical trial and is administering (applying) clinical trial drugs or clinical trial medical devices;
- •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
研究组 & 干预措施
Treatment group
patients with gastroesophageal reflux disease
干预措施: Fexuprazan Hydrochloride (Drug)
结局指标
主要结局
Average score change in RDQ
时间窗: at 4 weeks (up to 8 weeks)
Average score change in RDQ at 4 weeks (up to 8 weeks) from baseline
次要结局
- Overall improvement evaluated by the researchers(at 4 weeks (up to 8 weeks))
- RDQ validity rate(at 4 weeks (up to 8 weeks))
- Average individual score change in RDQ(at 4 weeks (up to 8 weeks))
- Overall improvement evaluated by the subjects(at 4 weeks (up to 8 weeks))