Gastroesophageal RefluxNCT07291700
Study on Hydrotalcite for Relief of Acid Symptoms Due to Acid Rebound After Stopping Long-Term PPI Therapy
An observational study of Gastroesophageal Reflux, run by Bayer at 2 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- Hydrotalcite (Talcid, BAYX002833)
- Type of treatment
- Pill or oral medicine
- How many people
- 167 participants
- Where
- 2 sitesGermany
- Study dates
- 18 Nov 2025to 31 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
- irritable bowel syndrome
- subjects who receive Non-Steroidal Anti-Inflammatory drug (NSAID) treatment with no warning signals* regarding ulcers
- polymedication** with no warning signals* or side effects regarding ulcers
- unclarified upper abdominal discomfort
- mild forms of GERD; like Non-Erosive Reflux Disease (NERD), Los Angeles (LA) grade A/B esophagitis
- Suffer from acid-rebound due to a discontinuation of a non/no longer indicated long-term PPI therapy (≥ 8 weeks of therapy)
- No endoscopically diagnosed GERD***
- No indication for a PPI-therapy according to guidelines.
Examples for guideline recommendations for a PPI-therapy:
- moderate - severe forms of reflux esophagitis
- gastric ulcer, duodenal ulcer
- Helicobacter pylori eradication
- moderate/severe forms of GERD - Los Angeles (LA) grade C/D esophagitis
- Zollinger-Ellison-Syndrome
No Talcid® contraindications or warnings as:
- pregnancy and lactation
- severe renal impairment
- hypophosphatemia
- existing myasthenia gravis
- impaired renal function
- Alzheimer's disease or other forms of dementia
- patients under low-phosphate diet
- hypersensitivity to the ingredients of Talcid®
- Subjects who voluntarily agree to use Talcid® Chewable Tablets for relief of acid-related symptoms due to acid-rebound
- Decision to initiate on-demand treatment of acid-related symptoms due to acid-rebound with Talcid® was made as per investigator's routine recommendation practice and by the subject
- Subject purchases Talcid® for her/his own use
- Signed informed consent
- No participation in an investigational program with interventions outside of routine clinical practice
- No contraindications according to the local marketing authorization
- Warning signals:
- Age > 60 (with one additional warning signal)
- Previous history or family history of ulcers
- Helicobacter pylori positive status Polymedication: defined as at least five medicinal products at the same time for a continuous therapy * Endoscopy: LA grade C/ D esophagitis, Barrett esophagus, peptic stricture; pH- Impedance measurement: acid exposure > 6%
Exclusion Criteria: not applicable
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
Bayer Vital GmbH
Leverkusen, 51373
- Not yet recruiting
Bayer Germany
Wuppertal, 42096
About this study
Official title: A Non-Interventional Study to Investigate the Effectiveness of Hydrotalcite to Relieve Acid-Related Symptoms Due to an Acid Rebound After Discontinuation of a Non/No Longer Indicated Long-Term PPI Therapy.
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.
Read more
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.
- Conditions
- Gastroesophageal Reflux
- Being tested
- Hydrotalcite (Talcid, BAYX002833)
- Keywords
- Heartburn,, Gastroesophageal Reflux,, Nausea,, Epigastric Pain,, Feeling of Fullness,, Acid-related Symptoms,, Acid Rebound
- Medical subject headings
- Gastroesophageal Reflux, Heartburn, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrotalcite (Talcid, BAYX002833)Drug
Talcid Chewable Tablet (500 mg hydrotalcite) taken on-demand for acid-related symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Talcid (hydrotalcite) 500mg chewable tablet Receives: Drug: Hydrotalcite (Talcid, BAYX002833) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (8)
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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 )
Measured: Baseline and at the end of the 4-week treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start18 Nov 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 167 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07291700
- Sponsor's protocol ID
- 22800
- Status last verified
- Jul 2026
- First submitted
- 17 Nov 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Interventional Study to Investigate the Effectiveness of Hydrotalcite to Relieve Acid-Related Symptoms Due to an Acid Rebound After Discontinuation of a Non/No Longer Indicated Long-Term PPI Therapy.
- ClinicalTrials.gov ID
- NCT07291700
- Acronym / sponsor ID
- 22800
- Conditions
- Gastroesophageal Reflux
- Keywords
- Heartburn,, Gastroesophageal Reflux,, Nausea,, Epigastric Pain,, Feeling of Fullness,, Acid-related Symptoms,, Acid Rebound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 167 participants (estimated)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Hydrotalcite (Talcid, BAYX002833)Talcid (hydrotalcite) 500mg chewable tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrotalcite (Talcid, BAYX002833)Talcid Chewable Tablet (500 mg hydrotalcite) taken on-demand for acid-related symptoms. | Drug | Group 1 |
Primary outcome
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
Time frame: 4 weeks
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.
8 secondary outcomes
Score (5-point rating scale) of overall relief from acid-related symptoms due to an acid rebound when used as an on-demand treatment
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
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
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
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
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)
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 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
Time frame: Baseline and at the end of the 4-week treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux, run by Bayer at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bayer Clinical Trials Contact ((+)1-888-84 22937, clinical-trials-contact@bayer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.