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

Официальное название

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.

Обзор

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.

Вмешательства

• Препарат Hydrotalcite (Talcid, BAYX002833)
  Talcid Chewable Tablet (500 mg hydrotalcite) taken on-demand for acid-related symptoms.

Первичные конечные точки

• 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 [Срок оценки: 4 weeks]

Вторичные конечные точки (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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline and at the end of the 4-week treatment]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Германия · 2 центра

• Bayer Vital GmbH — Leverkusen
• Bayer Germany — Wuppertal

Идентификаторы

NCT: NCT07291700 · 22800

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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