Study on Hydrotalcite for Relief of Acid Symptoms Due to Acid Rebound After Stopping Long-Term PPI Therapy

Bayer

Status

Enrolling

Conditions

Gastroesophageal Reflux

Treatments

Drug: Hydrotalcite (Talcid, BAYX002833)

Study type

Observational

Funder types

Industry

Identifiers

NCT07291700

22800

Details and patient eligibility

About

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.

Enrollment

167 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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%