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

3 1 1

What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Spitalul Clinic Judetean De Urgenta Cluj Cluj Napoca Romania
Futuremeds Sp. z o.o. Wroclaw Poland
Zaniewski Bilski Sp. z o.o. Olsztyn Poland

Other Sites

Site Name City Country Status
Central Hospital Of Northern Pest Military Hospital Budapest Hungary
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov Sofia Bulgaria
Medical Center Hera EOOD Sofia Bulgaria
Medical Centre Futuremeds EOOD Plovdiv Bulgaria
PreventaMed s.r.o. Olomouc Czechia
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j. Bydgoszcz Poland
Nowe Zdrowie-Ck Kieltucki I Wspolnicy Sp. j. Staszow Poland
Centrum Medyczne Oporow Wroclaw Poland
Vita Longa Sp. z o.o. Katowice Poland
Vasutegeszseguegyi Nonprofit Koezhasznu Kft. Debrecen Hungary
Szpital Miejski Sw. Jana Pawla II W Elblagu Elblag Poland
Eugastro GmbH Leipzig Germany
Multiprofile Hospital For Active Treatment Sveti Ivan Rilski 2003 OOD Dupnitsa Bulgaria
SurGal Clinic s.r.o. Brno-Sever Czechia
Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD Gorna Oryahovitsa Bulgaria
Tvm Med Serv S.R.L. Cluj Napoca Romania
MVZ CCB Frankfurt Und Main-Taunus GbR Frankfurt Germany
MBAL Sveta Karidad EAD Plovdiv Bulgaria
Bonifraterskie Centrum Medyczne Sp. z o.o. Lodz Poland
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz Szekesfehervar Hungary
Etg Neuroscience Sp. z o.o. Warsaw Poland
Clinexpert Kft. Budapest Hungary
Dkc Fokus-5 Lzip OOD Sofia Bulgaria
Spitalul Clinic Colentina Bucuresti Bucharest Romania
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Fakultni Nemocnice Brno Brno Czechia
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD Sofia Bulgaria
Synexus Polska Sp. z o.o. Poznan Poland
Diagnostic Consultation Center XX-Sofia EOOD Sofia Bulgaria
Vojenska Nemocnice Brno Brno-Zidenice Czechia
Javorszky Odon Korhaz Vac Hungary
University Multiprofile Hospital For Active Treatment Eurohospital Plovdiv Ltd. Plovdiv Bulgaria
Gastromed Sp. z o.o. Torun Poland
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ Lodz Poland
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
University Of Szeged Szeged Hungary
Multiprofile Hospital For Active Treatment Vita Ltd. Sofia Bulgaria
G1 Intezet Kft. Budapest Hungary
Wielkopolskie Centrum Medyczne Sp. z o.o. Poznan Poland
Jst Sp. z o.o. Czestochowa Poland
Gwiwafimo Ktxvqjb Rjwhfnzurh Szefymghtc Sjd jx Bialystok Poland
Tbiwcodp Nzgg Sms z ooqj Warsaw Poland
Mxpvinf cxhhtb Osmtdk Lmau Sofia Bulgaria
Dcohqqfisj Cwbinwhctx Cbhzlt 1 Souxey Ehbd Sliven Bulgaria
Pcxll Chtkasw Mgfi Euxv Vlydsv Vratsa Bulgaria
Euyoddkj Mkpylr sbnasf Zabreh Czechia
Nphjrfhbd Ppfbdoeoby alcn Prachatice Czechia
Gtnqzugvokg sqfrih Pardubice Czechia
Dvupj Mqgownxy gqfxe Mannheim Germany
Pxfilqe Prpncxec fgg Gmgmdgomnkrdicsi Heidelberg Germany
Swdksbq Carbhmaxxobzi Smw z onwa Warsaw Poland
Oiypipp Bsfel Kicadrqyxrd Cstcgbqap Sacd Etn Gsfcjtegyhihw Mqfuegtpdy Tvmkrxq Bydgoszcz Poland
Mgemwhj Celhtn Dur Mxepddyi Eudq Kyustendil Bulgaria
Pryucmgrohx Ezqukikonqdq Wroclaw Poland
Mcoiitkd Sd z ocxu Bydgoszcz Poland
Ezp Zbnith Zamosc Poland
Stqoeagqovicoo Mlc Dytrrc Dachau Germany
Ukftp Sjxvm Msfojd Pqmgdi Ogb Pleven Bulgaria
Wmb Wctckl Ive Pclgm Piwlvcfk Kqditoi Warsaw Poland
Mxhgkghe Svk z ofre Oświęcim Poland

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

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Recruiting
15.08.2025
Czechia Czechia
Recruiting
15.08.2025
Germany Germany
Recruiting
15.08.2025
Hungary Hungary
Recruiting
15.08.2025
Poland Poland
Recruiting
15.08.2025
Romania Romania
Recruiting
15.08.2025

Trial locations

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).

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 ID:
2024-518714-31-00
Protocol code:
CX842A2301
Trial Phase:
Therapeutic confirmatory (Phase III)

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