💬In plain words
What the trial is, and whether it could suit you
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 effectiv
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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