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Comparing 7-Day and 4-Week Esomeprazole Treatment in Patients with Unexplained Dyspepsia

Registered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study looks at dyspepsia, which is a condition that causes discomfort or pain in the upper part of the stomach, often described as indigestion. People with dyspepsia may experience symptoms such as bloating, feeling full quickly, nausea, or a burning sensation in the stomach area. The treatment being used in this study is esomeprazole, a medication that reduces the amount of acid produced in the stomach. This type of medication is commonly used to help relieve symptoms related to stomach acid. In addition to esomeprazole, the study also includes a product called Rennie, which contains calcium carbonate and magnesium carbonate and is used as a rescue medication for quick relief of symptoms when needed.

The purpose of this study is to compare two different lengths of treatment with esomeprazole to see if a shorter treatment period works as well as a longer one in reducing dyspepsia symptoms. Some people in the study will take esomeprazole for seven days, while others will take it for four weeks. The study will measure changes in symptoms using a scoring system called the Glasgow Dyspepsia Severity Score, which tracks how severe the symptoms are over time. The study aims to determine whether the shorter treatment is not worse than the longer treatment, meaning it provides similar relief.

During the study, participants will take esomeprazole by mouth according to their assigned treatment schedule. They will record their symptoms daily so that researchers can track any changes. The maximum daily dose of esomeprazole will be 40 milligrams, and participants may use Rennie as needed for additional symptom relief. The study will last for several weeks, during which time participants will continue to monitor their symptoms. If symptoms do not improve or worsen, participants may be referred for an upper gastrointestinal endoscopy, which is a procedure that allows doctors to look inside the stomach and upper digestive tract using a thin tube with a camera.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment period assignment

    Upon joining the study, you will be randomly assigned to one of two treatment groups. One group will receive esomeprazole treatment for 7 days, while the other group will receive the same treatment for 4 weeks.

    Esomeprazole is a medication that reduces the amount of acid produced in the stomach. It is used to treat symptoms of indigestion.

  2. Step 2

    Daily medication intake

    You will take esomeprazole 40 mg capsules by mouth. The capsules are designed to resist stomach acid and release the medication in the intestine.

    The duration of your treatment will depend on which group you are assigned to: either 7 days or 4 weeks (28 days).

    You will also have access to Rennie tablets, which contain calcium carbonate and magnesium carbonate. These are chewable tablets that can be used as needed for symptom relief. Each tablet contains 680 mg of calcium carbonate and 80 mg of magnesium carbonate.

  3. Step 3

    Daily symptom tracking during weeks 1 to 4

    From day 1 through day 28 (weeks 1 to 4), you will record your indigestion symptoms daily using a modified version of the Glasgow Dyspepsia Severity Score.

    This scoring system helps measure the severity of your symptoms such as pain, discomfort, heartburn, and other digestive issues.

    Your daily scores from the first week (days 1-7) will be compared to your scores from weeks 2-4 (days 8-28) to assess how your symptoms change over time.

  4. Step 4

    Follow-up period

    After the initial 4-week period, you will continue to be monitored during weeks 5 to 7.

    During this time, you will continue to track your daily symptoms using the same scoring system.

    This follow-up period allows for assessment of your symptoms after the treatment period has ended.

  5. Step 5

    Monitoring for additional procedures

    Throughout the study period (weeks 1 through 7), any need for an upper gastrointestinal endoscopy will be recorded.

    An upper gastrointestinal endoscopy is a procedure where a thin tube with a camera is used to examine the inside of the esophagus, stomach, and upper part of the small intestine.

Who can join the trial?

6 criteria

  • You must be between 18 and 60 years old when you join the study
  • You must have unexplained dyspepsia, which means you have symptoms like stomach pain, burning, or discomfort in your upper belly that doctors cannot explain
  • You must have a negative test for H. pylori, which is a type of bacteria that can live in your stomach and cause problems
  • You must not have taken PPI therapy in the last three months. PPIs are medicines called proton pump inhibitors that reduce the amount of acid your stomach makes
  • You must have had a previous upper endoscopy that showed normal results. An upper endoscopy is a test where a doctor uses a thin tube with a camera to look inside your throat, food pipe, and stomach
  • You must be able to understand Icelandic or English language

Who cannot join the trial?

2 criteria

  • The study does not list specific reasons why patients cannot participate
  • If you have concerns about whether you can join this study, you should discuss your individual health situation with the study doctor
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Investigated drugs

Esomeprazole is a medication that reduces the amount of acid produced in the stomach. It belongs to a group of medicines called proton pump inhibitors (PPIs). In this trial, it is being used to treat symptoms of unexplained dyspepsia, which includes discomfort or pain in the upper stomach area. The study compares different lengths of treatment with this medication to see which works better for relieving these symptoms.

What is already known about the treatment

Esomeprazole – Esomeprazole is a medication that belongs to a group called proton pump inhibitors, which work by reducing the amount of acid produced in the stomach by blocking tiny pumps in the stomach lining cells that release acid. It is widely approved and commonly used in medical practice for treating conditions related to excess stomach acid, such as heartburn, acid reflux, and stomach ulcers. In this clinical trial, esomeprazole is being studied for treating unexplained dyspepsia (indigestion), comparing whether a short 7-day treatment works as well as a longer 4-week treatment course. The medication is typically taken as a tablet or capsule by mouth, usually once daily before a meal.

Investigated diseases

Dyspepsia – Dyspepsia is a condition characterized by recurring pain or discomfort in the upper abdomen. Patients typically experience symptoms such as bloating, feeling uncomfortably full after eating, nausea, or burning sensations in the stomach area. The symptoms may occur during or after meals and can vary in intensity from mild to severe. Dyspepsia can be caused by various factors including stomach acid irritation, inflammation of the stomach lining, or problems with how the stomach processes food. The condition may be persistent or occur in episodes over time. Some people experience symptoms daily while others have periods where symptoms improve or worsen.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524044-35-00Estimated enrolment128 patientsSponsorLandspitali

sourced from the EU Clinical Trials Register and site verification

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