NCT06668506已完成不适用
A Multi-center, Prospective, Observational Study to Evaluate Improvement Effect of Subjective Symptoms of Mucotra SR Tablet in Patients With Gastritis
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 2,814 人开始时间: 2022年3月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,814
- 试验地点
- 1
- 主要终点
- Change in total subjective symptom score compared to baseline
研究概览
简要总结
This study aims to evaluate the improvement effect on subjective symptoms of gastritis and adverse events through patient self-assessment results (PRO) by conducting follow-up observations for patients with gastritis at 2 to 4 weeks after administration of Mucotra® SR tablets.
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
- •Men or women aged ≥ 19 years
- •Subjects with acute or chronic gastritis, requiring treatment with Mucotra® SR tab
- •Subjects with subjective symptoms
- •Subjects who voluntarily consent to participate in this observational study
排除标准
- •Subjects who have had a hypersensitivity reaction to the components of Mucotra® SR tab
- •Subject with genetic disorders such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
结局指标
主要结局
Change in total subjective symptom score compared to baseline
时间窗: 2 weeks (up to 4 weeks)
Change in total subjective symptom score compared to baseline at 2 weeks (up to 4 weeks) on a scale of 0 to 3 points for 8 items (epigastric pain, severe pain, nausea/vomiting, acid reflux, bloating, poor appetite, heartburn, burping). Higher scores are indicative of more severe symptoms.
次要结局
- Change in individual subjective symptom score compared to baseline(2 weeks (maximum 4 weeks))
- The effective rate of subjective symptoms compared to baseline(2 weeks (maximum 4 weeks))
- Overall change assessed by study subjects after administration of the study drug(2 weeks (maximum 4 weeks))
- Overall change assessed by the researcher after administration of the drug under study(2 weeks (maximum 4 weeks))
- Adverse events that occurred after administration of Mucotra® extended-release tablets(2 weeks (maximum 4 weeks))
研究者
研究点 (1)
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