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
- Conditions
- HeartburnR12
- Registration Number
- DRKS00029344
- Lead Sponsor
- Hälsa Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 100
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
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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Due to the exploratory approach of the PMCF study, all parameters are listed here without differentiation into primary and secondary outcomes:<br>- Time to onset of symptom relief (Event Questionnaire filled in at every event)<br>- Severity score and the frequency score of the RESQ-7 (day 0, 7, 14, 21 and 28)<br>- Duration of action (per event)<br>- Global assessment of performance (day 28)<br>- Global assessment of satisfaction and quality of life (day 28)<br>- Study participant’s willingness to recommend product to a friend (day 28)<br>- Documentation of safety-related findings (day 14, day 28)<br>- Global assessment of tolerability by study participant and investigator (day 28)<br>- Global assessment of application / user-friendliness (day 28)<br>
- Secondary Outcome Measures
Name Time Method Due to exploratory approach of the PMCF study all parameters are listed in primary outcomes without differentiation in primary and secondary outcomes.