DRKS00029344已完成不适用
Post-Market Clinical Follow-up Study to endorse the performance and safety of Refluthin® chewable tablets in the rapid and lasting relief of heartburn and acid-related gastric discomfort - BTS1821/21
Hälsa Pharma GmbH0 个研究点目标入组 100 人开始时间: 2022年7月4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
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1. Adult study participants (= 18 years) with symptomatic heartburn, acid regurgitation
- •and/or recurrent acid related gastric discomfort
- •2. Indication for use of Refluthin® chewable tablets, according to the IFU and the
- •investigator’s judgement
- •3. Written informed consent
- •4. Willingness, not to use any other prescription and non-prescription medication or medical
- •device for treatment of heartburn and acid reflux symptoms during the Post-Market
- •Clinical Follow-up Study
排除标准
- •1. History of gastroesophageal reflux disease (GERD) that requires or has previously required treatment with prescription medications, surgery or endoscopic therapy including Transoral incisionless fundoplication (TIF).
- •2. History of heartburn or acid reflux symptoms caused by prescription medication, Barrett's esophagus, Hiatal hernia, esophagitis, cancer
- •3. Hypersensitivity or allergy to any of the product ingredients
- •4. Hereditary fructose intolerance
- •5. Renal disorders such as kidney stones or renal dysfunction
- •6. Known high blood or urine calcium concentrations
- •7. Known low blood phosphate level
- •8. Study participants taking thiazide diuretics (indicated for high blood pressure or cardiac insufficiency)
- •9. Study participants not able to follow study procedures, e.g. due to language barrier or mental /psychological disorders
- •10. Study participants under any clinical investigation in the last 30 days
研究者
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