A Multicenter, Double-blind, Randomized, Investigator-initiated Trial to Evaluate the Degree of Symptom Relief of Zastaprazan and Esomeprazole in Patients With Erosive Reflux Disease With Night-time Heartburn Symptoms
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 10
- 主要终点
- Proportion of participants without sleep disturbance related to nighttime heartburn during the last 7 days
研究概览
简要总结
Gastroesophageal reflux disease (GERD) is a condition caused by the reflux of stomach contents into the esophagus, presenting with typical symptoms such as heartburn and acid regurgitation.
GERD is a chronic condition that affects quality of life, and patients with this condition are known to have a lower quality of life compared to healthy individuals. In particular, nocturnal heartburn can lead to sleep deprivation and affect daily life, as well as overall quality of life.
This study aims to evaluate the efficacy of alleviating nocturnal heartburn symptoms in patients with erosive reflux disease (ERD).
详细描述
This multicenter, double-blind, randomized, active-controlled Phase 4 study aims to exploratorily evaluate the comparative effects and safety of zastaprazan 20 mg and esomeprazole 40 mg in subjects with gastroesophageal reflux disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
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
- •Korean adults aged 19 years or older as of the date of written consent
- •Those diagnosed with erosive gastroesophageal reflux disease based on upper gastrointestinal endoscopy (EGD)
- •Those who reported nighttime heartburn for more than 3 months at the time of screening (Visit 1)
- •Those who voluntarily decided to participate and provide written informed consent
排除标准
- •Those who cannot undergo upper gastrointestinal endoscopy (EGD)
- •Individuals with a history of drug or alcohol abuse (within the past year)
- •Individuals who have received other investigational products within one month prior to the screening visit (Visit 1)
- •In addition to the above, individuals with clinically significant findings that the investigator deems medically inappropriate for the present study
研究组 & 干预措施
Zastaprazan
Zastaprazan 20 mg, once daily, preferably administered orally in the morning before breakfast for four weeks
干预措施: Zastaprazan (Drug)
Esomeprazole
Esomeprazole 40 mg, once daily, preferably administered orally in the morning before breakfast for four weeks
干预措施: Esomeprazole (Drug)
结局指标
主要结局
Proportion of participants without sleep disturbance related to nighttime heartburn during the last 7 days
时间窗: Week 2
This measure is based on participant-reported information collected by subject diary during the study and reflects whether sleep disturbance related to heartburn was noted over the period evaluated. Symptom severity ranges from 0 to 4, with higher scores indicating worse sleep disturbance.
次要结局
- Proportion of participants without sleep disturbance related to nighttime heartburn during the last 7 days(Week 4)
- Mean change from baseline in Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) score(Baseline, Week 2, Week 4)
- Mean change from baseline in Gastrointestinal Symptom Rating Scale (GSRS) score(Baseline, Week 2, Week 4)
- Change from baseline in Gastroesophageal Reflux Disease Questionnaire (GerdQ) score(Baseline, Week 2, Week 4)
研究者
Byung-Wook Kim
Professor
Incheon St.Mary's Hospital