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Comparison of linaprazan glurate versus lansoprazole for healing of erosive esophagitis in adults with gastroesophageal reflux disease

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What is this trial about?

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

This study focuses on treating erosive esophagitis, a condition where the lining of the food pipe becomes damaged due to gastroesophageal reflux disease (GERD). GERD occurs when stomach acid frequently flows back into the tube connecting the mouth and stomach. The study will compare two medications: linaprazan glurate and lansoprazole, which are both drugs that reduce stomach acid production.

The purpose of this research is to determine if linaprazan glurate is more effective than lansoprazole in healing erosive esophagitis. Some participants will receive linaprazan glurate tablets, while others will receive lansoprazole capsules. Some participants will receive placebo. The treatment will continue for up to 8 weeks.

During the study, doctors will examine the healing of the food pipe using a thin, flexible tube with a camera that allows them to see the condition of the esophagus. Participants will also need to keep track of their symptoms, particularly heartburn, using an electronic diary. The study will monitor any side effects that occur during the treatment period.

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

    Initial examination and medication assignment

    You will undergo an endoscopy examination to confirm the presence of erosive esophagitis (EE), a condition where the esophagus becomes inflamed due to acid reflux.

    You will be randomly assigned to receive either linaprazan glurate tablets (50mg) or lansoprazole for treatment.

  2. Step 2

    First treatment period

    You will take the assigned medication orally for 4 weeks.

    During this period, you will need to complete an electronic diary each day to record any heartburn symptoms.

    The diary will help track how many days you are free from heartburn symptoms.

  3. Step 3

    Week 4 assessment

    After 4 weeks of treatment, you will undergo another endoscopy to check if your condition has improved.

    The medical team will evaluate the healing of your esophagus.

    Your electronic diary entries will be reviewed to assess changes in heartburn symptoms.

  4. Step 4

    Extended treatment period

    If needed, treatment will continue for an additional 4 weeks (8 weeks total).

    You will continue recording daily symptoms in your electronic diary.

  5. Step 5

    Final assessment

    At week 8, you will have a final endoscopy to evaluate the overall healing of your esophagus.

    The medical team will review your complete symptom diary and assess any side effects experienced during the treatment.

    Your participation in the study will end after this assessment.

Who can join the trial?

9 criteria

  • Must sign an Informed Consent Form showing understanding of the study procedures
  • Age between 18 and 80 years old at the time of signing the consent form
  • Must be able to:
    • undergo endoscopy procedures (examination of the esophagus using a flexible camera)
    • provide blood samples for analysis
    • swallow tablets and capsules
    • use electronic devices for study documentation
    • Must have confirmed erosive esophagitis (damage to the lining of the esophagus) due to gastroesophageal reflux disease (GERD) of grades A to D, as confirmed by endoscopy examination and reviewed by independent specialists
    • Can be either male or female
    • Must be willing to follow all study requirements and procedures

Who cannot join the trial?

14 criteria

  • History of surgery that could affect how the stomach and food pipe work (like stomach reduction or bypass surgery)
  • Current or past cancer of the food pipe or stomach
  • Active bleeding in the stomach or intestines
  • Severe liver problems
  • Severe kidney problems
  • Pregnancy or breastfeeding
  • Known allergies to the study medications (linaprazan glurate or lansoprazole)
  • Taking medications that might interact with the study drugs
  • Current participation in another clinical trial
  • Inability to follow study procedures
  • Untreated H. pylori infection (a type of bacteria that can live in the digestive tract)
  • History of serious heart problems in the last 6 months
  • Alcohol or drug abuse within the past year
  • Any condition that the study doctor believes would make participation unsafe
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Investigated drugs

  • Linaprazan glurate

    is a new medication being studied for treating erosive esophagitis, a condition where stomach acid damages the esophagus. It belongs to a class of drugs that reduce stomach acid production through a different mechanism than traditional acid-reducing medications.

  • Lansoprazole

    is a well-established medication commonly used to reduce stomach acid production. It belongs to a class of medications called proton pump inhibitors (PPIs), which help heal damage to the esophagus caused by acid reflux. It is often used to treat conditions like erosive esophagitis and GERD (gastroesophageal reflux disease).

What is already known about the treatment

  • Linaprazan glurate

    An investigational medication administered orally twice daily (BID) that belongs to a class of potassium-competitive acid blockers (P-CABs) designed to treat erosive esophagitis caused by gastroesophageal reflux disease (GERD). This drug works by directly blocking the acid-producing proton pumps in the stomach, providing rapid and potent acid suppression. Currently undergoing Phase 3 clinical trials, it is being studied at a 50 mg dosage against lansoprazole to demonstrate superior healing effects in patients with severe forms of erosive esophagitis.

  • Lansoprazole

    A well-established proton pump inhibitor (PPI) medication taken orally that reduces stomach acid production by blocking the proton pump in gastric cells. This medication is commonly prescribed for treating erosive esophagitis, GERD, and other acid-related conditions, working by decreasing the amount of acid produced in the stomach to allow healing of damaged tissue. It has been approved by regulatory authorities and has been in clinical use for many years as a standard treatment option for acid-related disorders.

Investigated diseases

  • Erosive Esophagitis (EE)

    A condition where stomach acid causes inflammation and damage to the lining of the esophagus, resulting in erosions or ulcers in the esophageal tissue. It occurs as a complication of gastroesophageal reflux disease (GERD), where stomach contents flow back into the esophagus. The condition typically develops gradually, with the esophageal lining becoming increasingly damaged over time. Symptoms include burning pain in the chest, difficulty swallowing, and discomfort when eating.

  • Gastroesophageal Reflux Disease (GERD)

    A digestive disorder that occurs when stomach acid frequently flows back into the esophagus, causing irritation of the esophageal lining. The condition develops due to weakness or improper functioning of the lower esophageal sphincter, which normally prevents stomach contents from moving upward. Common symptoms include heartburn, chest pain, regurgitation of food or sour liquid, and difficulty swallowing. The condition can be chronic, with symptoms occurring regularly over time.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518714-31-00Protocol codeCX842A2301Estimated enrolment514 patientsSponsorCinclus Pharma Holding AB (publ)

sourced from the EU Clinical Trials Register and site verification

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