NCT07028671已完成不适用
Exploratory Pilot Investigation of Motilium's Effectiveness and Safety for the OTC Treatment of Dyspepsia-related Symptoms Among Chinese Suffers Using Real-world Evidence: A Non-interventional, Prospective, Observational Study
Johnson & Johnson Consumer and Personal Products Worldwide1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年12月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Effectiveness of Motilium
研究概览
简要总结
This study aims to understand the effectiveness and safety of Motilium among study participants with dyspepsia-related symptoms in real-world settings in China.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals purchased OTC Motilium at pharmacies for themselves for the treatment of one or more dyspepsia-related symptoms including postprandial fullness, early satiation, epigastric pain, epigastric burning, belching, epigastric bloating, nausea, and vomiting
- •Provided signed and dated informed consent
排除标准
- •Individuals who suffered from dyspepsia-related symptoms ≥ 3 days/week for at least 3 months prior to joining the study
- •Individuals who suffered exclusively from heartburn
- •Individuals taking or planning to take dyspepsia-related medication, including but not limited to proton pump inhibitors, hydrotalcite, Talcid, Sanjiu Weitai, JianWeiXiaoShiPian, Jiangzhong Jianwei, Digestive enzyme, Itopride, Mosapride, and Famotidine
- •History of, or current, cardiac disease or cardiac arrhythmias including QT prolongation, ventricular tachycardia, ventricular fibrillation and Torsades de Pointes
- •Any of the following warning signs: black stool, unintended weight loss, progressive dysphagia, persistent vomiting, abdominal mass, and fever
- •Diagnosed with accompanying GI or other disease (e.g., GI tumors, peptic ulcer, and hiatal hernia)
- •Conditions with elevated health risk if having increased gastric motility (e.g., GI hemorrhage, mechanical obstruction or perforation)
- •Hepatic dysfunction and renal insufficiency
- •Concomitant use with oral ketoconazole, erythromycin, or other potent inhibitors of CYP3A4 enzymes that may prolong the QTc interval (refer to Chinese OTC label. e.g., fluconazole, voriconazole, clarithromycin, amiodarone, telithromycin, itraconazole, posaconazole, ritonavir, saquinavir, and telaprevir)
- •Known allergies to Motilium (domperidone) or any other ingredient of Motilium
- •Pregnant, breast feeding female or planning to become pregnant (either potential participant or potential participant's partner)
- •Individuals who are currently taking Motilium
- •Individuals who did not get relieved from dyspepsia-related symptoms after taking Motilium
- •Individuals participating in any other clinical trials during this study
结局指标
主要结局
Effectiveness of Motilium
时间窗: Day 7
To evaluate the effectiveness of Motilium for treating dyspepsia-related symptoms among adult study participants who purchase OTC Motilium in China
Safety of Motilium
时间窗: Day 7
To evaluate safety of treatments, based on adverse event (AE) reporting throughout the study period
次要结局
未报告次要终点
研究者
研究点 (1)
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