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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00029344

Enrollment

100

Registered

2022-07-04

Start date

2022-07-21

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

R12

Interventions

Group 1: Refluthin® chewable tablets up to 4 tablets/day over a maximum period of 30 days (with interruption)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Due to the exploratory approach of the PMCF study, all parameters are listed here without differentiation into primary and secondary outcomes: - Time to onset of symptom relief (Event Questionnaire filled in at every event) - Severity score and the frequency score of the RESQ-7 (day 0, 7, 14, 21 and 28) - Duration of action (per event) - Global assessment of performance (day 28) - Global assessment of satisfaction and quality of life (day 28) - Study participant’s willingness to recommend product to a friend (day 28) - Documentation of safety-related findings (day 14, day 28) - Global assessment of tolerability by study participant and investigator (day 28) - Global assessment of application / user-friendliness (day 28)	—

Measure

Time frame

Due to the exploratory approach of the PMCF study, all parameters are listed here without differentiation into primary and secondary outcomes: - Time to onset of symptom relief (Event Questionnaire filled in at every event) - Severity score and the frequency score of the RESQ-7 (day 0, 7, 14, 21 and 28) - Duration of action (per event) - Global assessment of performance (day 28) - Global assessment of satisfaction and quality of life (day 28) - Study participant’s willingness to recommend product to a friend (day 28) - Documentation of safety-related findings (day 14, day 28) - Global assessment of tolerability by study participant and investigator (day 28) - Global assessment of application / user-friendliness (day 28)

—

Secondary

Measure	Time frame
Due to exploratory approach of the PMCF study all parameters are listed in primary outcomes without differentiation in primary and secondary outcomes.	—

Countries

Germany

Contacts

Public ContactCarina Nitschinger

BioTeSys GmbH

studienzentrum@biotesys.de071131057152

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026