Actively Recruiting
Observational Study of Hydrotalcite Talcid for Treating Acid Rebound Symptoms After Stopping Long-Term Proton Pump Inhibitor PPI Therapy
Led by Bayer · Updated on 2026-07-07
167
Participants Needed
2
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
This observational study investigates the use of hydrotalcite, marketed as Talcid, to relieve acid-related symptoms caused by acid rebound after stopping long-term proton pump inhibitor PPI therapy that is no longer indicated. PPIs are commonly prescribed to reduce stomach acid for conditions like heartburn and ulcers, but stopping long-term use can lead to symptoms such as heartburn returning. The study focuses on adults in Germany who have discontinued non-indicated PPI therapy and are experiencing these rebound symptoms. Participants will use hydrotalcite as an on-demand treatment over a four-week period when symptoms occur. They will take Talcid chewable tablets and record symptom relief, the time it takes for relief, and overall satisfaction. Doctors will also evaluate the treatments suitability, tolerability, and effectiveness. The study does not involve randomization or intervention but collects real-world data from about twenty sites. During the study, participants will complete standardized questionnaires to report their symptoms and satisfaction. Researchers will measure how many participants successfully stop PPI use during the four weeks and assess relief from heartburn, reflux, pain, fullness, and nausea. Quality of life changes and investigators ratings of the treatment will also be recorded. The study plans to enroll around 167 participants to ensure about 100 complete the study by October 2026.
CONDITIONS
Brief Title
Study on Hydrotalcite for Relief of Acid Symptoms Due to Acid Rebound After Stopping Long-Term PPI Therapy
Research Team
B
Bayer Clinical Trials Contact
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