A Study Comparing the Effect and Safety of Linaprazan Glurate to Lansoprazole in Participants With Erosive Esophagitis (EE) Due to Gastroesophageal Reflux Disease (GERD)

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

August 31, 2026

Study Completion Date

September 30, 2026

Conditions
GERD (Gastroesophageal Reflux Disease)
Interventions
DRUG

Linaprazan glurate 50 mg Twice Daily (BID)

"Participants in this group will receive a total daily dose of 100 mg of linaprazan glurate, administered as 50 mg in the morning and 50 mg in the evening.~In the morning, they take one 50 mg linaprazan glurate tablet along with a placebo capsule that matches the appearance of the lansoprazole capsule. In the evening, they take another 50 mg linaprazan glurate tablet, without any additional placebo."

DRUG

Linaprazan Glurate 50 mg Once Daily (QD)

"Participants in this group will receive a total daily dose of 50 mg of linaprazan glurate, taken once daily in the morning.~In the morning, they take one 50 mg linaprazan glurate tablet along with a placebo capsule that mimics the lansoprazole capsule. In the evening, they take a placebo tablet that mimics the appearance of the linaprazan glurate tablet."

DRUG

Lansoprazole 30 mg Once Daily (QD)

"Participants in this group will receive a total daily dose of 30 mg of lansoprazole, taken once daily in the morning.~In the morning, they take one 30 mg lansoprazole capsule along with a placebo tablet that mimics the linaprazan glurate tablet. In the evening, they take another placebo tablet resembling linaprazan glurate."

Trial Locations (75)

1036

G1 Institute, Budapest

1343

"Medical Center Orange", Sofia

1407

"Multiprofile Hospital for Active Treatment - Vita", Sofia

1431

Diagnostic and Consulting Center Alexandrovska, Sofia

1463

Diagnostic Consultative Center - Focus-5, Sofia

1510

Medical Center Hera, Sofia

1527

"University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL", Sofia

1606

"University Multiprofile Hospital for Active Treatment and Emergency Medicine N.I. Pirogov", Sofia

1618

20th Diagnostic Consultancy Center, Sofia

2500

Medical Center Hera, Kyustendil

2600

"Multiprofile Hospital for Active Treatment Sv. Ivan Rilski - 2003 OOD", Dupnitsa

3000

First Private Hospital Vratsa, Vratsa

LTD Aversi Clinic, Marneuli

4000

"Multiprofile Hospital for Active Treatment Sveti Panteleymon", Plovdiv

4600

JSC Georgian Clinics, Kutaisi

5100

Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD, Gorna Oryahovitsa

5800

"University Multiprofile Hospital for Active Treatment Sveta Marina", Pleven

6000

Khozrevanidze's Clinic, Batumi

38301

Hospital Prachatice a.s., Prachatice

53003

Gastromedic s.r.o., Pardubice

68163

Diakonie Hospital, Mannheim

78901

Endohope Morava s.r.o., Zábřeh

81379

Clinic for Internal Medicine Munich-Sued, Munich

85221

Medical Care Unit Dachau, Dachau

400006

Cluj Napoca County Emergency Clinical Hospital, Internal Medicine III, Cluj-Napoca

400061

TVM MED SERV SRL, Medical Center for Gastroenterology, Hepatology and Digestive Endoscopy, Cluj-Napoca

Unknown

Diagnosis - Consulting Centre 1, Sliven

602 00

SurGal Clinic s.r.o., Brno

615 00

Military Hospital Brno, Internal Department, Brno

625 00

University Hospital Brno, Brno

779 00

PreventaMed s.r.o., Olomouc

0101

LTD Krol Medical Corporation, Tbilisi

0114

The New Hospitals, Tbilisi

0119

Israeli - Georgian Medical Research Clinic Healthycore LLC, Tbilisi

0144

Janmrtelobis Sakhli LLC, Tbilisi

LLC Geo Hospitals, Tbilisi

0160

LTD Aversi Clinic, Tbilisi

0178

LEPL The First University Clinic of Tbilisi State Medical University, Tbilisi

0180

Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC, Tbilisi

H-5600

Bekes County Central Hospital Dr. Rethy Pal Member Hospital, 4th Department of Internal Medicine - Gastroenterology - Hepatology, Békéscsaba

H-1033

Clinexpert Ltd. Budapest, Budapest

H-1036

Obuda Healthcare Center Ltd., Budapest

Synexus Hungary Ltd., Budapest

H-1062

Central Hospital of Northern Pest - Military Hospital, Department of Gastroenterology, Budapest

H-4025

Main Railway Outpatient Clinic Debrecen, Department of Gastroenterology, Debrecen

H-3300

Heves County Markhot Ferenc Teaching Hospital and Clinic, Department of General and Vascular Surgery, Eger

H-6720

University of Szeged, Department of Internal Medicine- Western Site, Szeged

H-8000

Fejer County St. Gyorgy University Teaching Hospital, Department of Internal Medicine I, Székesfehérvár

H-2600

Javorszky Odon Hospital Vac, Department of Gastroenterology, Vác

15-322

NZOZ Specialist Gastrology Centre GASTROMED, Bialystok

85-229

"MEDIS Medical Center", Bydgoszcz

85-231

NZOZ KERmed Medical Centre, Bydgoszcz

85-794

CLINSANTE Clinical Research Centre Ewa Galczak-Nowak, Malgorzata Trzaska, Bydgoszcz

82-300

St. John Paul 2nd Municipal Hospital in Elblag, Department of Internal Diseases, Elblag

80-382

Synexus Polska Sp. z o.o. Branch in Gdansk, Gdansk

40-040

Synexus Polska Sp. z o.o. Branch in Katowice, Katowice

40-748

"Vita Longa Non-Public Healthcare Facility, Limited Liability Company", Katowice

30-688

Independent Public Healthcare Facility University Hospital in Krakow, NSSU Endoscopy Department, Krakow

31-501

FutureMeds Krakow, Krakow

90-153

Independent Public Healthcare Facility, Norbert Barlicki University Teaching Hospital No. 1 of the Medical University in Lodz, Clinical Department of General Gastroenterology and Oncology, Lodz

93-357

Hospital of Brothers Hospitallers of Saint John of God In Lodz, Endoscopy Lab, Lodz

32-600

Oswiecim Clinical Trial Centre, Oświęcim

60-309

EMC Medical Institute Joint Stock Company, CERTUS Private Healthcare Facility Hospital No. 1, CERTUS Private Healthcare Facility Ambulatories, Poznan

60-702

Synexus Polska Sp. z o.o. Branch in Poznan, Poznan

28-200

New health-CK, Kieltucki and partners g.p., Staszów

87-100

Gastromed Sp. z o.o. (LLC), Torun

00-215

FutureMeds Warsaw Center, Warsaw

01-595

Therapia Nova, Warsaw

02-677

ETG Warszawa, Warsaw

03-291

Futuremeds Targowek, Warsaw

04-501

WIP Warsaw IBD Point Profesor Kierkus, Warsaw

52-416

Medical Centre Oporow, Wroclaw

53-673

FutureMeds Wroclaw, Wroclaw

22-400

ETG Zamosc, Zamość

020125

Colentina Clinical Hospital, Department of Gastroenterology, Bucharest

Sponsors
All Listed Sponsors
lead

Cinclus Pharma Holding AB

INDUSTRY