Europas førende søgning efter kliniske forsøg

Sodium Alginate

Clinical trials are studying Sodium Alginate in people with heartburn, reflux, and functional dyspepsi. These studies look at how well it works in treatment plans, especially when reducing or replacing long-term proton pump inhibitor (PPI) use. The goal is to measure success, patient satisfaction, and willingness to continue treatment.

Table of Contents

Trial overview

The main trial in this data set is NCT05629143, called the Primary carE PPi dEprescRibing (PEPPER) trial.[1] It is a completed Phase 3 interventional study with 745 participants.[1]

The study looked at treatment strategies for people with heartburn, functional dyspepsia, and reflux.[1] The trial specifically studied how Sodium Alginate could be used in a plan to reduce or replace long-term PPI treatment.[1]

Who was studied

The trial focused on patients who were chronically using PPIs but did not have a clear reason to keep using them long term.[1] This means the study was not about all people with reflux symptoms, but about a specific group already taking acid-suppressing medicine for a long time.[1]

The conditions listed in the trial were heartburn, functional dyspepsia, and reflux.[1] These are common upper stomach and food-pipe symptoms that can affect daily comfort and treatment choices.[1]

What was tested

The study compared two newer deprescribing strategies with a more traditional step-down approach for PPIs.[1] One strategy was on-demand PPI use, which means using the medicine only when needed.[1]

The other strategy was replacing PPI therapy with an alginate formulation.[1] In the trial data, this replacement approach is the one linked to Sodium Alginate.[1]

The comparison group used a classical approach, meaning gradual lowering of the PPI dose through fixed intermittent intake.[1] The researchers wanted to see whether the newer strategies would work better than the standard step-down method.[1]

Trial phase and design

This was a Phase 3 study, which usually means the treatment strategy is being tested in a larger group to see how well it works in real patient care.[1] The study was also interventional, meaning the researchers assigned treatment strategies and then measured the results.[1]

The trial was designed to compare success across different deprescribing approaches for long-term PPI users.[1] The study hypothesis was that the new strategies, including the Sodium Alginate replacement approach, would perform better than the standard gradual reduction approach.[1]

The trial also planned to compare the two newer strategies against each other.[1] In the study description, the on-demand PPI strategy was expected not to be worse than the alginate replacement strategy.[1]

Main endpoints

The main outcome was the percentage of randomized patients who achieved a successful therapeutic outcome by the end of follow-up.[1] This means the researchers did not look at only one symptom, but at an overall result for each patient.[1]

Success was based on three patient-reported points: PPI use, treatment satisfaction, and willingness to continue treatment.[1] These points were summed to decide whether the treatment strategy worked well for the patient.[1]

What the results measure

The outcome measure is patient-centered, which means it focuses on how the patient feels about the treatment and whether the treatment fits daily life.[1] This is important in deprescribing studies because the goal is not only to reduce medicine use, but also to keep symptoms controlled and maintain acceptable treatment satisfaction.[1]

Because the study used a follow-up period, the results reflect what happened over time rather than only at one visit.[1] The completed trial adds useful information about whether a Sodium Alginate-based replacement strategy can help in long-term PPI reduction plans for people with upper stomach symptoms.[1]

Trial IDPhaseCondition studiedStatusEnrollment
NCT05629143Phase 3Heartburn, functional dyspepsia, refluxCompleted745

FAQ

  • What are clinical trials of Sodium Alginate trying to find out? They are studying whether Sodium Alginate can help in treatment plans for people with heartburn, reflux, and functional dyspepsia. In the main trial, it is tested as a replacement strategy when reducing long-term PPI use.
  • Who can take part in these trials? The trial data describe patients who are chronically using PPIs without a clear reason for long-term use. The study focuses on people with heartburn, functional dyspepsia, or reflux.
  • What phase is the Sodium Alginate trial? The trial is listed as Phase 3. This means it is a later-stage study that looks at how well the treatment strategy works in a larger group of patients.
  • What is measured in the study? The main outcome is the percentage of patients with a successful therapeutic outcome at the end of follow-up. This is based on three patient-reported points: PPI use, treatment satisfaction, and willingness to continue treatment.
  • How many people are in the trial? The trial includes 745 participants. It is an interventional study, which means the researchers assign treatment strategies and compare the results.

Igangværende kliniske forsøg for Sodium Alginate

  • Undersøgelse af bedste måde at stoppe syrepumpehæmmere hos patienter med funktionel dyspepsi (mavesmerter uden kendt årsag)

    Rekrutterer ikke

    1 1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Belgien

Ordliste

  • Heartburn: A burning feeling in the chest or upper stomach, often linked to acid coming up from the stomach.
  • Reflux: When stomach contents move upward into the food pipe, which can cause burning or discomfort.
  • Functional dyspepsia: Ongoing upper stomach discomfort or pain without a clear structural cause found in tests.
  • Proton pump inhibitor (PPI): A medicine often used to lower stomach acid. In this trial, the focus is on reducing or replacing long-term PPI use.
  • Deprescribing: A planned way of reducing or stopping a medicine that may no longer be needed.
  • Randomized: Patients are assigned by chance to different treatment groups, so the groups can be compared fairly.
  • Interventional study: A study where researchers give a treatment strategy and then measure the results.
  • Phase 3: A later stage of clinical research that tests how well a treatment strategy works in a larger group of people.
  • Follow-up period: The time after treatment starts when patients are checked to see how they are doing.
  • Treatment satisfaction: How happy a patient is with the treatment they receive.
  • Willingness to continue: Whether the patient wants to keep using the treatment after the study period.

Referencer

  1. https://kliniske-forsoeg.dk/forsog/undersogelse-af-bedste-made-at-stoppe-syrepumpehaemmere-hos-patienter-med-funktionel-dyspepsi-mavesmerter-uden-kendt-arsag/