An observational study in Gastroesophageal Reflux, sponsored by Bayer. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Bayer · Observational
This observational study aims to explore the effectiveness of hydrotalcite, marketed as Talcid, in alleviating acid-related symptoms that occur due to an acid rebound after discontinuing a non-/no-longer-indicated long-term proton pump inhibitor (PPI) therapy. PPIs are commonly prescribed to reduce stomach acid to alleviate symptoms such as heartburn and for the treatment of, for example, duodenal and stomach ulcers. Discontinuation after prolonged use can lead to a rebound effect where dyspeptic complaints such as heartburn occur once the medication is stopped. This study is conducted in Germany and involves adult participants who have stopped using non-/no-longer-indicated PPIs and are experiencing these rebound symptoms.
Hydrotalcite is recommended by physicians as an on-demand treatment for managing acid-related symptoms. The study seeks to gather real-world evidence on its effectiveness, consumer experience, and acceptance to support claims about its use to relieve acid related symptoms due to an acid rebound. Participants will use hydrotalcite as needed (on demand when symptoms occur) over a four-week period, and will record information about symptom relief, the time it takes for relief to occur, and overall satisfaction with the treatment. Additionally, their doctors rate the suitability, tolerability, and effectiveness of the treatment.
The primary objective of the study is to assess the effectiveness of hydrotalcite by the number and percentage of patients not having used PPIs during the study period. Secondary objectives include evaluating relief from specific symptoms (heartburn, reflux, epigastric pain, feeling of fullness, and nausea, as well as improvements in quality of life due to hydrotalcite treatment. The study will also assess participants' satisfaction with hydrotalcite as an on-demand treatment and its suitability for managing these symptoms.
Participants will be adults aged 18 and older who have discontinued a long-term PPI therapy (≥8 weeks) for which there is no current indication according to indication and guidelines and who are experiencing acid rebound symptoms after stopping the PPI therapy. The study will exclude individuals with endoscopically diagnosed gastroesophageal reflux disease (GERD) (LA grade C/ D esophagitis) or those with hydrotalcite contraindications or warnings, such as pregnancy, severe renal impairment, or allergies to its ingredients.
Data will be collected through standardized questionnaires completed by participants after they consent to join the study. The study aims to enroll approximately 167 participants, anticipating a 40% drop-out rate, to ensure around 100 completed questionnaires. Statistical analyses will be exploratory and descriptive, focusing on categorical and continuous variables.
The study is designed to be observational, meaning there will be no direct intervention or randomization of participants. Instead, it will collect primary data directly from participants and investigators across approximately twenty sites in Germany. The results will provide valuable insights into the effectiveness of hydrotalcite in managing acid rebound symptoms and may inform future treatment recommendations for participants discontinuing long-term PPI therapy.
1,211 studies on the registry are indexed under Gastroesophageal Reflux; 202 are open to participants now.
This study's planned enrollment of 167 is close to the median of 178 across 348 observational studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult subjects aged 18 years and older for whom there is not/no longer an indication for a daily PPI therapy according to approval status and guidelines, and who suffer from acid related symptoms due to an acid rebound after discontinuation of a non/no longer indicated long-term PPI-therapy (≥8 weeks).
Eligibility Criteria:
Adult female or male subjects aged ≥ 18
Subjects who have discontinued daily PPI therapy (≥ 8 weeks of therapy) for which there is no current indication according to guidelines and approval status, e.g.
Examples for guideline recommendations for a PPI-therapy:
No Talcid® or warnings as:
to the ingredients of Talcid®
No contraindications according to the local marketing authorization
* Warning signals:
Exclusion Criteria: not applicable
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Talcid (hydrotalcite) 500mg chewable tablet
Drug: Hydrotalcite (Talcid, BAYX002833)
Talcid Chewable Tablet (500 mg hydrotalcite) taken on-demand for acid-related symptoms.
Number and percentage of subjects successfully discontinued proton pump inhibitor (PPI) therapy defined as no intake of PPI within a period of 4 weeks after start of treatment
Number and percentage of subjects successfully discontinued PPI therapy defined as no intake of PPI within a period of 4 weeks after start of hydrotalcite (500 mg Talcid chewable tablets) as on-demand treatment to treat symptoms due to acid-rebound.
Time frame: 4 weeks
Score (5-point rating scale) of overall relief from acid-related symptoms due to an acid rebound when used as an on-demand treatment
Overall relief from acid-related symptoms (by subject): Assessed using a 5-point rating scale (1 = Very Poor, 2 = Poor, 3 = Moderate, 4 = Good, 5 = Very Good) in the evening after Talcid® Chewable tablet intake.
Time frame: Daily during 4-week treatment period
Number and percentage of subjects satisfied with hydrotalcite (Talcid® Chewable Tablets) as an on-demand treatment for treating their acid-related symptoms due to an acid-rebound
Overall satisfaction assessment (by subject): Assessed at the end of the 4-week on-demand Talcid® Chewable Tablets treatment period using a 7-point rating scale (1 = Strongly Dissatisfied, 2 = Dissatisfied, 3 = Slightly Dissatisfied; 4 = Neither Satisfied nor Dissatisfied, 5 = Slightly Satisfied, 6 = Satisfied, 7= Strongly Satisfied).
Time frame: once at the end of the 4-week treatment period
Number and percentage of investigators considering hydrotalcite (Talcid® Chewable tablets) being suitable as an on-demand treatment for treating acid-related symptoms due to an acid-rebound
Suitability assessment (by Investigator): Assessed at the final data collection timepoint using a 5-point rating scale (1 = Not Suitable, 2 = Not Very Suitable, 3 = Neutral, 4 = Suitable, 5 = Very Suitable).
Time frame: once at final data collection timepoint at the end of the 4-week treatment period
Number and percentage of investigators considering hydrotalcite (Talcid® Chewable tablets) being well tolerated as an on-demand treatment for treating acid-related symptoms due to an acid-rebound
Tolerability assessment (by Investigator): Assessed at final data collection timepoint using a 5-point rating scale (1 = Very Poor Tolerability, 2 = Poor Tolerability, 3 = Neutral, 4 = Well Tolerated, 5 = Very Well Tolerated).
Time frame: once at final data collection timepoint at the end of the 4-week treatment period
Number and percentage of investigators considering hydrotalcite (Talcid® Chewable tablets) being effective as an on-demand treatment for treating acid-related symptoms due to an acid-rebound
Effectiveness assessment (by Investigator): Assessed at the final data collection timepoint using a 5-point rating scale (1 = Not Effective at All, 2 = Not Very Effective, 3 = Neutral, 4 = Effective, 5 = Very Effective).
Time frame: once at final data collection timepoint at the end of the 4-week treatment period
Scores (5-point rating scale) of relief from heartburn, reflux, epigastric pain, feeling of fullness, and nausea due to an acid-rebound when used as an on-demand treatment (Talcid® Chewable tablets)
Specific symptom relief assessments (by subject): Assessment of relief of heartburn, reflux, epigastric pain, feeling of fullness, nausea in the evening after Talcid® Chewable Tablets intake using a 5-point rating scale (1 = Very Poor, 2 = Poor, 3 = Moderate, 4 = Good, 5 = Very Good).
Time frame: Daily during 4-week treatment period
Time to relief of heartburn, reflux, epigastric pain, feeling of fullness, and nausea following intake of hydrotalcite (Talcid® Chewable tablets) when used on-demand
Time to relief assessments (by subject): Assessment of time to relief from each of the following symptoms heartburn, reflux, epigastric pain, feeling of fullness, nausea in the evening after Talcid® Chewable Tablets intake using pre-specified time frames (\<5, 5- 10, 10-15, 15-30, 30-60, 60-90 and \>90 minutes).
Time frame: Daily during 4-week treatment period
Change in scores (5-point rating scale) of quality of life due to hydrotalcite (Talcid® Chewable tablets) on-demand treatment towards baseline
Quality of Life Assessment (by subject): Assessed at baseline and at the end of the 4-week ondemand Talcid® Chewable Tablets treatment period using a 5-point category scale (1 = Very Poor, 2 = Poor, 3 = Moderate, 4 =Good , 5 = Very Good )
Time frame: Baseline and at the end of the 4-week treatment
Plan to share: No — Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Oct 2027, 23 months after the start.
Of 116 observational studies under Gastroesophageal Reflux, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 167. This study's planned 23 months is below that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 10, 2026: primary completion Oct 2026 → Oct 2027 and completion Oct 2026 → Oct 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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