#1 Clinical Trials Search in Europe

Study on Stopping Esomeprazole in Patients with Liver Cirrhosis

3 1 1

What is this study about?

This clinical trial is focused on studying the effects of stopping a type of medication called proton-pump inhibitors (PPIs) in patients with liver cirrhosis. Liver cirrhosis is a condition where the liver becomes severely scarred and is unable to function properly. The medication being studied is called Nexium, which contains the active ingredient esomeprazole magnesium trihydrate. This study will compare patients who stop taking Nexium with those who continue taking it, using a placebo for comparison.

The purpose of the study is to determine the time it takes for patients to experience their first unplanned re-hospitalization or death over a period of 12 months. Participants will be randomly assigned to either stop or continue their PPI treatment. The study will monitor various health outcomes, including any infections, liver-related complications, and changes in the gut bacteria over time.

Throughout the study, participants will be closely observed to gather information on their health status and any changes that occur. The trial aims to provide valuable insights into the effects of discontinuing long-term PPI therapy in individuals with liver cirrhosis, potentially guiding future treatment decisions for this condition.

1 joining the study

Upon joining the study, the patient must have a confirmed diagnosis of liver cirrhosis. This can be determined through medical tests or a combination of clinical signs.

The patient must have been treated with a proton-pump inhibitor (PPI) for at least 28 days before the study begins, with a standard dose taken daily for at least 7 days before the screening.

2 randomization

The patient will be randomly assigned to one of two groups: the intervention group or the control group.

The intervention group will stop taking the PPI, while the control group will continue the PPI treatment.

3 medication administration

The medication used in the study includes esomeprazole magnesium trihydrate and a placebo. Both are administered orally in the form of gastro-resistant tablets.

The dosage for the PPI, if continued, is 20 mg per day.

4 monitoring period

The study will monitor the patient for a period of 12 months (360 days) to observe the time to first unplanned re-hospitalization or death.

Regular assessments will be conducted to track any infections, liver-related complications, or gastrointestinal bleeding events.

5 end of study

At the end of the 12-month period, the study will conclude, and the patient’s health outcomes will be evaluated.

The primary focus will be on the time to first unplanned re-hospitalization or death, while secondary outcomes include any infections and changes in intestinal microbiota.

Who Can Join the Study?

  • Must be an adult, meaning 18 years or older.
  • Must have given written permission to participate, known as informed consent.
  • Must have liver cirrhosis, which is a condition diagnosed by tests or signs from the body.
  • Must have been in the hospital or recently hospitalized (within the last 42 days) due to complicated liver cirrhosis.
  • Must have been taking a type of medication called a proton-pump inhibitor (PPI) for at least 28 days before the study starts. PPIs are medicines that reduce stomach acid.
  • Must have been taking a single standard dose or less of PPI each day for at least 7 days before the study starts.
  • If female or male, must agree to follow the study’s rules about preventing pregnancy.
  • If female, must not be pregnant or breastfeeding.
  • Must be able to understand the study information and personally sign and date the consent form before any study activities begin.
  • Must be willing to cooperate and be available for the entire duration of the study.

Who Cannot Join the Study?

  • Patients who do not have liver cirrhosis cannot participate. Liver cirrhosis is a condition where the liver is damaged and scarred.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Patients who are not willing to stop or continue their current proton-pump inhibitor (PPI) therapy as required by the study cannot participate. PPI therapy involves medications that reduce stomach acid.
  • Patients who are part of a vulnerable population, such as those with additional health conditions that make them more at risk, may not be eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Hochschule Hannover Hanover Germany
University Hospital Jena KöR Jena Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Technische Universitaet Dresden Dresden Germany

Other Sites

Site Name City Country Status
Universitaetsklinikum Aachen AöR Aachen Germany
Universitaetsklinikum Brandenburg an der Havel GmbH Brandenburg An Der Havel Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Saarland University Hospital Homburg Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Universitaetsklinikum Leipzig AöR Leipzig Germany
Uimoxaeemi Mbvobgd Chwsak Hjtgpunrncwotobvv Hamburg Germany
Upokqssecannkkuqezdwd Eygbk Ahn Essen Germany
Zcqqnfk Fmnh Ixzuzr Mgltdws Rostock Germany
Uhfmnsskqvxvsnffwcvwt Mbfzmeqp Aux Munster Germany
Goaclv Uxducmueoh Favuzduyg Frankfurt Germany
Mvtgxgjuxdktjvzqelfmthyvbq Hnkxonjkigoszyxm Halle (Saale) Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
01.09.2020

Trial locations

Investigated drugs:

Proton-Pump Inhibitors (PPIs) are medications that reduce the amount of acid produced in the stomach. They are commonly used to treat conditions like acid reflux, stomach ulcers, and other digestive issues. In this clinical trial, patients with liver cirrhosis are either continuing or discontinuing their long-term use of PPIs to see how it affects their health, specifically looking at the time to first unplanned re-hospitalization or death.

Liver cirrhosis – Liver cirrhosis is a condition where the liver gradually becomes scarred and loses its ability to function properly. This scarring is often the result of long-term damage from factors like chronic alcohol use or viral hepatitis. As the disease progresses, the liver’s ability to filter toxins, produce proteins, and store energy is impaired. Symptoms may include fatigue, jaundice, and swelling in the legs and abdomen. Over time, complications such as fluid buildup, infections, and bleeding can occur. The progression of cirrhosis can lead to liver failure if the underlying cause is not addressed.

Trial ID:
2023-509863-26-00
Protocol code:
STOPPIT
Trial Phase:
Human Pharmacology (Phase I) – Other

Other Trials to Consider

  • A Study Comparing Human Albumin and Saline Solution for Treating Kidney Injury in Patients with Advanced Liver Cirrhosis

    Recruiting

    3 1 1 1
    Investigated drugs:
    Spain

  • Study on the Effect of Carvedilol for Patients with Cirrhotic Portal Hypertension

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France