Clinical trial • Phase III • Gastroenterology

LINAPRAZAN GLURATE for Erosive esophagitis due to gastroesophageal reflux disease (GERD)

Phase III trial of LINAPRAZAN GLURATE for Erosive esophagitis due to gastroesophageal reflux disease (GERD).

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Erosive esophagitis due to gastroesophageal reflux disease (GERD)
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
19-12-2025
First CTIS Authorization Date
28-04-2026

Trial design

Randomised, lansoprazole; dose and schedule not specified in english documentation-controlled Phase III trial across 71 sites in Bulgaria, Czechia, Germany and others.

Randomised
Yes
Comparator
Lansoprazole; dose and schedule not specified in English documentation
Target Sample Size
96
Trial Duration For Participant
378

Eligibility

Recruits 96 No vulnerable population selected. Participants must understand and voluntarily sign an Informed Consent Form (ICF) prior to initiation of any trial-related assessments/procedures. No assent/consent procedures for minors are described..

Pregnancy Exclusion
11. Women who are pregnant or breast feeding
Vulnerable Population
No vulnerable population selected. Participants must understand and voluntarily sign an Informed Consent Form (ICF) prior to initiation of any trial-related assessments/procedures. No assent/consent procedures for minors are described.

Inclusion criteria

  • {"criterion_text":"- An individual who has participated in a preceding linaprazan glurate healing trial will be asked to participate in this trial if the following criteria apply: 1. The participant understands and voluntarily signs an Informed Consent Form (ICF) prior to initiation of any trial-related assessments/procedures.\n- 2. The participant has a healed EE as assessed by central review of endoscopic examination either from the last regular visit in a preceding phase 3 healing trial OR from the Run-in Period to the present maintenance trial.\n- 3. The participant is willing and able to comply with all aspects of the protocol (including endoscopies, tablet and capsule swallowing, electronic device [e-device] completion, etc.)."}

Exclusion criteria

  • {"criterion_text":"- An individual who has participated in a preceding linaprazan glurate phase 3 healing trial can be enrolled in this maintenance trial unless they meet any of the following exclusion criteria: 1. EE as graded from the endoscopy during the Run-in Period (only applicable for participants with previous endoscopy >14 days before the last regular visit in the preceding healing trial).\n- 10. Current or history of alcohol, drug abuse, and/or use of androgens/anabolic steroids (testosterone and testosterone esters [enanthate, undecanoate, cypionate], methyltestosterone, oxandrolone, stanozolol, fluoxymesterone, danazol, tetrahydrogestrinone, 7α-methyl-19-nortestosterone) within 2 years prior to Run-in Period. Stable androgen substitution treatment for male hypogonadism is allowed.\n- 11. Women who are pregnant or breast feeding\n- 12. Individual is an employee of the Investigator, trial site, Sponsor, or Contract Research Organization (CRO) with direct involvement in the proposed trial or other trials under the direction of that Investigator, trial site, Sponsor, or CRO, as well as family members of the employee of the Investigator, trial site, Sponsor, or CRO.\n- 13. Individuals who have previously participated (completed or withdrawn) in this trial.\n- 14. A female participant of childbearing potential who is or may be sexually active with a non-sterilized male partner and who is unwilling to routinely use highly effective contraception from the signing of the ICF until 7 days after the last dose of IP.\n- 15. A male participant with a partner of childbearing potential who is unwilling to routinely use highly effective contraception and is unwilling to agree to not father a child from the signing of the ICF until at least 7 days after the last dose of IP.\n- 2. Solitary esophageal ulcer in the proximal two-thirds of the esophagus, untreated Barrett’s esophagus or any other condition affecting the esophagus, including eosinophilic esophagitis; esophageal varices; viral or fungal infection; esophageal stricture.\n- 3. Significant noncompliance with protocol-specified procedures or treatment in the preceding healing trial as judged by the Investigator.\n- 4. Adverse event (AE) resulting in premature discontinuation of IP in the preceding healing trial.\n- 5. History or presence of any clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, neurological disease or disorder, or psychiatric diagnosis which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or influence the trial results or the participant’s ability to participate in the trial. The following examples are conditions that would exclude the participant from participating: a. History of myocardial infarction/ acute coronary syndrome within 3 months prior to the M0 visit b. History of ventricular arrhythmia or implanted cardioverter defibrillator c. Symptomatic congestive heart failure (New York Heart Association [NYHA] class 3-4) d. Family history of/ diagnosis of hereditary arrhythmia syndrome\n- 6. History of adult asthma that required intensive treatment in an emergency room\n- 7. Any planned major surgery within 52 weeks of the Run-in Period.\n- 8. Any clinically significant laboratory parameter outside reference value that has occurred since Screening or Baseline values in the preceding healing trial and which, in the opinion of the Investigator, may suggest a new or insufficiently understood disease, may present an unreasonable risk to the participant as a result of his/her participation in the trial, or may interfere with trial assessments. The below laboratory test results during the Run-in Period* (HX/M0 visit) are exclusionary: a. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 × upper limit of normal (ULN) for the central laboratory conducting the test. b. Serum total bilirubin (TBL) >1.5 × ULN for the central laboratory conducting the test. (individuals with Gilbert’s syndrome can be included). *Note: One retest is allowed during the Run-in Period.\n- 9. Enrollment in another interventional clinical trial, except for ongoing participation in an EE healing trial with linaprazan glurate."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 1.Maintained healing of EE after 24 weeks as assessed by central reading of endoscopy.","definition_or_measurement_approach":"Assessed by central reading of endoscopy."}

Secondary endpoints

  • {"endpoint_text":"- 1. Maintained healing of EE after 24 weeks as assessed by central reading of endoscopy","definition_or_measurement_approach":"Assessed by central reading of endoscopy."}
  • {"endpoint_text":"- 2. Maintained healing from EE as assessed by central reading of endoscopy after 24 weeks in participants with Baseline EE due to GERD of LA grades C/D.","definition_or_measurement_approach":"Assessed by central reading of endoscopy in subgroup with baseline LA grades C/D."}
  • {"endpoint_text":"- 3. Percentage of heartburn-free days from Baseline to Week 24 based on electronic Diary","definition_or_measurement_approach":"Participant-reported via electronic diary; percentage of 24-hour heartburn-free days from baseline to Week 24."}
  • {"endpoint_text":"- 4. Maintained healing of EE comparing linaprazan glurate ‘high dose’ with lansoprazole after 52 weeks as assessed by central reading of endoscopy.","definition_or_measurement_approach":"Assessed by central reading of endoscopy at Week 52 comparing linaprazan glurate high dose vs lansoprazole."}
  • {"endpoint_text":"- 5. Maintained healing of EE comparing linaprazan glurate ‘low dose’ with lansoprazole after 52 weeks as assessed by central reading of endoscopy","definition_or_measurement_approach":"Assessed by central reading of endoscopy at Week 52 comparing linaprazan glurate low dose vs lansoprazole."}

Recruitment

Planned Sample Size
96
Recruitment Window Months
44
Consent Approach
Participants must 'understand and voluntarily sign an Informed Consent Form (ICF) prior to initiation of any trial-related assessments/procedures.' ICF and related documents (including pregnancy follow-up ICF) are available in multiple languages (EN, DE, PL, HU, RO, BUL and others) as indicated in the submitted documents.

Geography

Total Number Of Sites
71
Total Number Of Participants
96

Bulgaria

Earliest CTIS Part Ii Submission Date
27-03-2026
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
38
Number Of Sites
18
Number Of Participants
18

Sites

Site Name
Multiprofile Hospital For Active Treatment Vita Ltd.
Department Name
Department of Gastroenterology
Principal Investigator Name
Vasil Koynarski
Principal Investigator Email
v.koynarski_2024@abv.bg
Contact Person Name
Vasil Koynarski
Contact Person Email
v.koynarski_2024@abv.bg
Site Name
Diagnostic Consultation Center XX-Sofia EOOD
Principal Investigator Name
Dimitar Dimitrov
Principal Investigator Email
dr.dimitar.dimitrov.mg@gmail.com
Contact Person Name
Dimitar Dimitrov
Site Name
Multiprofile Hospital For Active Treatment Sveti Ivan Rilski 2003 OOD
Department Name
Department of Internal Medicine
Principal Investigator Name
Vasil Bachev
Principal Investigator Email
vas_bachev@abv.bg
Contact Person Name
Vasil Bachev
Contact Person Email
vas_bachev@abv.bg
Site Name
Diagnostic Consulting Center 1 Sliven EOOD
Principal Investigator Name
Dimitar Pavlov
Principal Investigator Email
dr.pavlov.dimitar@gmail.com
Contact Person Name
Dimitar Pavlov
Contact Person Email
dr.pavlov.dimitar@gmail.com
Site Name
Dkc Fokus-5 Lzip OOD
Principal Investigator Name
Naiden Kandilarov
Principal Investigator Email
naidenk@mail.bg
Contact Person Name
Naiden Kandilarov
Contact Person Email
naidenk@mail.bg
Site Name
Medical Center Hera - Kyustendil EOOD
Principal Investigator Name
Kameliya Grigorova-Georgieva
Principal Investigator Email
dr.kameliyageorgieva@mail.bg
Contact Person Name
Kameliya Grigorova-Georgieva
Contact Person Email
dr.kameliyageorgieva@mail.bg
Site Name
MBAL Sveta Karidad EAD
Department Name
Department of Gastroenterology
Principal Investigator Name
Simon Sariyan
Principal Investigator Email
dr.s.sarian@abv.bg
Contact Person Name
Simon Sariyan
Contact Person Email
dr.s.sarian@abv.bg
Site Name
Medical Centre Futuremeds EOOD
Principal Investigator Name
Vesela Georgieva
Principal Investigator Email
vesela.georgieva@futuremeds.bg
Contact Person Name
Vesela Georgieva
Contact Person Email
vesela.georgieva@futuremeds.bg
Site Name
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
Department Name
Gastroenterology Clinic
Principal Investigator Name
Mila Kovacheva – Slavova
Principal Investigator Email
kovacheva.mila@gmail.com
Contact Person Name
Mila Kovacheva – Slavova
Contact Person Email
kovacheva.mila@gmail.com
Site Name
Medical Center Hera EOOD
Principal Investigator Name
Ivan Popadiyn
Principal Investigator Email
ivan.popadiin@heraclinics.com
Contact Person Name
Ivan Popadiyn
Contact Person Email
ivan.popadiin@heraclinics.com
Site Name
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
Department Name
Department of Gastroenterology
Principal Investigator Name
Kamen Danov
Principal Investigator Email
dr.danov@main.bg
Contact Person Name
Kamen Danov
Contact Person Email
dr.danov@main.bg
Site Name
UMHAT Sveta Marina Pleven OOD
Department Name
Department of Gastroenterology
Principal Investigator Name
Zornitsa Gorcheva
Principal Investigator Email
gorcheva@fhsmo.com
Contact Person Name
Zornitsa Gorcheva
Contact Person Email
gorcheva@fhsmo.com
Site Name
Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD
Department Name
First Department of Internal Medicine
Principal Investigator Name
Ilko Kosturkov
Principal Investigator Email
ikosturkov@mcmedicaplus.com
Contact Person Name
Ilko Kosturkov
Contact Person Email
ikosturkov@mcmedicaplus.com
Site Name
Purva Chastna Mbal EOOD Vratsa
Department Name
Department of Internal Medicine
Principal Investigator Name
Dobromir Dragoychev
Principal Investigator Email
dr_dragoichev@abv.bg
Contact Person Name
Dobromir Dragoychev
Contact Person Email
dr_dragoichev@abv.bg
Site Name
Diagnostic-Consultative Center Alexandrovska EOOD
Principal Investigator Name
Diana Stefanova– Petrova
Principal Investigator Email
prof.petrova@mail.bg
Contact Person Name
Diana Stefanova– Petrova
Contact Person Email
prof.petrova@mail.bg
Site Name
Medical center Orange Ltd.
Principal Investigator Name
Dimitar Stoyanov
Principal Investigator Email
stoyanov.md@mail.bg
Contact Person Name
Dimitar Stoyanov
Contact Person Email
stoyanov.md@mail.bg
Site Name
Multiprofile Hospital For Active Treatment St Panteleimon Plovdiv Ltd.
Department Name
Department of Gastroenterology
Principal Investigator Name
Dimitar Terziev
Principal Investigator Email
dr.dimitar.terziev@gmail.com
Contact Person Name
Dimitar Terziev
Contact Person Email
dr.dimitar.terziev@gmail.com
Site Name
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Department Name
Gastroenterology Clinic
Principal Investigator Name
Rosen Nikolov
Principal Investigator Email
roskinlk@gmail.com
Contact Person Name
Rosen Nikolov
Contact Person Email
roskinlk@gmail.com

Czechia

Earliest CTIS Part Ii Submission Date
27-03-2026
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
32
Number Of Sites
7
Number Of Participants
7

Sites

Site Name
Vojenska Nemocnice Brno
Department Name
Interní oddělení
Principal Investigator Name
David Štěpek
Principal Investigator Email
dstepek@vnbrno.cz
Contact Person Name
David Štěpek
Contact Person Email
dstepek@vnbrno.cz
Site Name
SurGal Clinic s.r.o.
Department Name
Oddělení chirurgie
Principal Investigator Name
Jan Ulbrych
Principal Investigator Email
ulbrych.jan@surgalclinic.cz
Contact Person Name
Jan Ulbrych
Contact Person Email
ulbrych.jan@surgalclinic.cz
Site Name
PreventaMed s.r.o.
Department Name
Interní ambulance
Principal Investigator Name
Jiří Pumprla
Principal Investigator Email
pumprla@vilazdravi.cz
Contact Person Name
Jiří Pumprla
Contact Person Email
pumprla@vilazdravi.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Interní gastroenterologická klinika a endoskopické centrum
Principal Investigator Name
Štefan Konečný
Principal Investigator Email
konecny.stefan@fnbrno.cz
Contact Person Name
Štefan Konečný
Contact Person Email
konecny.stefan@fnbrno.cz
Site Name
Endohope Morava s.r.o.
Department Name
Gastroenterologie
Principal Investigator Name
Evžen Machytka
Principal Investigator Email
machytka@endohope.cz
Contact Person Name
Evžen Machytka
Contact Person Email
machytka@endohope.cz
Site Name
Gastromedic s.r.o.
Principal Investigator Name
Václav Leksa
Principal Investigator Email
vaclav.leksa@seznam.cz
Contact Person Name
Václav Leksa
Contact Person Email
vaclav.leksa@seznam.cz
Site Name
Nemocnice Prachatice a.s.
Department Name
Gastroenterologická ambulance
Principal Investigator Name
Pavel Lipták
Principal Investigator Email
pavel.liptak@nempt.cz
Contact Person Name
Pavel Lipták
Contact Person Email
pavel.liptak@nempt.cz

Germany

Earliest CTIS Part Ii Submission Date
21-01-2026
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
98
Number Of Sites
5
Number Of Participants
5

Sites

Site Name
Diako Mannheim gGmbH
Principal Investigator Name
Dieter Schilling
Principal Investigator Email
d.schilling@bbtgruppe.de
Contact Person Name
Dieter Schilling
Contact Person Email
d.schilling@bbtgruppe.de
Site Name
Private Practice for Gastroenterology
Principal Investigator Name
Wolfgang Reindl
Principal Investigator Email
wr@hd-gastro.de
Contact Person Name
Wolfgang Reindl
Contact Person Email
wr@hd-gastro.de
Site Name
Eugastro GmbH
Principal Investigator Name
Ingolf Schiefke
Principal Investigator Email
ingolf.schiefke@eugastro.de
Contact Person Name
Ingolf Schiefke
Contact Person Email
ingolf.schiefke@eugastro.de
Site Name
Medical Care Unit Dachau
Principal Investigator Name
Wilfred Landry
Principal Investigator Email
landry@dachau-med.de
Contact Person Name
Wilfred Landry
Contact Person Email
landry@dachau-med.de
Site Name
MVZ CCB Frankfurt Und Main-Taunus GbR
Principal Investigator Name
Mate Knabe
Principal Investigator Email
knabe@gastroenterologie-frankfurt.de
Contact Person Name
Mate Knabe

Hungary

Earliest CTIS Part Ii Submission Date
21-01-2026
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
103
Number Of Sites
9
Number Of Participants
9

Sites

Site Name
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
Department Name
Department of Internal Medicine I
Principal Investigator Name
Roland Fejes
Principal Investigator Email
rfejes@mail.fmkorhaz.hu
Contact Person Name
Roland Fejes
Contact Person Email
rfejes@mail.fmkorhaz.hu
Site Name
Bekes Varmegyei Koezponti Korhaz
Department Name
4th Department of Internal Medicine - Gastroenterology - Hepatology
Principal Investigator Name
Marta Varga
Principal Investigator Email
gasztrobcs@bmkk.eu
Contact Person Name
Marta Varga
Contact Person Email
gasztrobcs@bmkk.eu
Site Name
Clinexpert Kft.
Principal Investigator Name
Zsanett Zsuzsanna Heringh
Principal Investigator Email
info@clinexpert.hu
Contact Person Name
Zsanett Zsuzsanna Heringh
Contact Person Email
info@clinexpert.hu
Site Name
Javorszky Oedoen Korhaz
Department Name
Department of Gastroenterology
Principal Investigator Name
Tibor Szaloki
Principal Investigator Email
szalokitdr@javorszky.hu
Contact Person Name
Tibor Szaloki
Contact Person Email
szalokitdr@javorszky.hu
Site Name
University Of Szeged
Department Name
Western Site Department of Internal Medicine
Principal Investigator Name
Andras Rosztoczy
Principal Investigator Email
rosztoczy.andras@med.u-szeged.hu
Contact Person Name
Andras Rosztoczy
Site Name
G1 Intezet Kft.
Principal Investigator Name
Levente Balint
Principal Investigator Email
info@g1intezet.hu
Contact Person Name
Levente Balint
Contact Person Email
info@g1intezet.hu
Site Name
Central Hospital Of Northern Pest Military Hospital
Department Name
Department of Gastroenterology Podmaniczky u. 111.
Principal Investigator Name
Tibor Gyokeres
Principal Investigator Email
epchk@epc-honvedkorhaz.hu
Contact Person Name
Tibor Gyokeres
Contact Person Email
epchk@epc-honvedkorhaz.hu
Site Name
Vasutegeszseguegyi Nonprofit Koezhasznu Kft.
Department Name
Department of Gastroenterology
Principal Investigator Name
Gyula G. Kiss
Principal Investigator Email
titkarsag@vasuteu.hu
Contact Person Name
Gyula G. Kiss
Contact Person Email
titkarsag@vasuteu.hu
Site Name
Clinexpert Kft. (additional site listing)
Principal Investigator Name
Zsanett Zsuzsanna Heringh
Principal Investigator Email
info@clinexpert.hu
Contact Person Name
Zsanett Zsuzsanna Heringh
Contact Person Email
info@clinexpert.hu

Romania

Earliest CTIS Part Ii Submission Date
10-03-2026
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
55
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Spitalul Clinic Judetean De Urgenta Cluj
Department Name
Internal Medicine III
Principal Investigator Name
Dan Lucian Dumitrascu
Principal Investigator Email
ddumitrascu@umfcluj.ro
Contact Person Name
Dan Lucian Dumitrascu
Contact Person Email
ddumitrascu@umfcluj.ro
Site Name
Tvm Med Serv S.R.L.
Department Name
Gastroenterology
Principal Investigator Name
Marcel Tantau
Principal Investigator Email
mtantau@gmail.com
Contact Person Name
Marcel Tantau
Contact Person Email
mtantau@gmail.com
Site Name
Spitalul Clinic Colentina Bucuresti
Department Name
Gastroenterology
Principal Investigator Name
Radu Bogdan Mateescu
Principal Investigator Email
bogmateescu@gmail.com
Contact Person Name
Radu Bogdan Mateescu
Contact Person Email
bogmateescu@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
30-03-2026
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
31
Number Of Sites
29
Number Of Participants
51

Sites

Site Name
Etg Zamosc Sp. z o.o.
Department Name
ETG Zamość
Principal Investigator Name
Katarzyna Wójcik
Principal Investigator Email
k.wojcik@etg-network.com
Contact Person Name
Katarzyna Wójcik
Contact Person Email
k.wojcik@etg-network.com
Site Name
Futuremeds Sp. z o.o. (Wroclaw)
Department Name
FutureMeds Wrocław
Principal Investigator Name
Rafał Wierzbicki
Principal Investigator Email
Rafal.wierzbicki@futuremeds.com
Contact Person Name
Rafał Wierzbicki
Site Name
Medical Network Sp. z o.o.
Department Name
WIP Warsaw IBD Point Profesor Kierkuś
Principal Investigator Name
Jarosław Kierkuś
Principal Investigator Email
j.kierkus@med-net.pl
Contact Person Name
Jarosław Kierkuś
Contact Person Email
j.kierkus@med-net.pl
Site Name
Etg Warszawa Sp. z o.o.
Department Name
ETG Warszawa
Principal Investigator Name
Marek Bugajski
Principal Investigator Email
m.bugajski@etg-network.com
Contact Person Name
Marek Bugajski
Contact Person Email
m.bugajski@etg-network.com
Site Name
Medicome Sp. z o.o.
Department Name
Oświęcimskie Centrum Badań Klinicznych
Principal Investigator Name
Iwona Kobielusz- Gembala
Principal Investigator Email
iwonagembala@wp.pl
Contact Person Name
Iwona Kobielusz- Gembala
Contact Person Email
iwonagembala@wp.pl
Site Name
Futuremeds Sp. z o.o. (Warsaw)
Department Name
FutureMeds Warszawa Centrum
Principal Investigator Name
Alina Walczak
Principal Investigator Email
alina.walczak@futuremeds.com
Contact Person Name
Alina Walczak
Contact Person Email
alina.walczak@futuremeds.com
Site Name
Manermed Sp. z o.o.
Department Name
Centrum Medyczne "MEDIS"
Principal Investigator Name
Maria Kłopocka
Principal Investigator Email
mariaklopocka@cm-medis.pl
Contact Person Name
Maria Kłopocka
Contact Person Email
mariaklopocka@cm-medis.pl
Site Name
Synexus Polska Sp. z o.o. (Gdansk)
Department Name
Oddział w Gdańsku
Principal Investigator Name
Marek Cesarz
Principal Investigator Email
marek.cesarz@trialmed.com
Contact Person Name
Marek Cesarz
Contact Person Email
marek.cesarz@trialmed.com
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 Im. Norberta Barlickiego Uniwersytetu Medycznego W Lodzi
Department Name
Oddział Kliniczny Gastroenterologii Ogólnej i Onkologicznej
Principal Investigator Name
Ewa Małecka-Wojciesko
Principal Investigator Email
ewa.malecka-panas@umed.lodz.pl
Contact Person Name
Ewa Małecka-Wojciesko
Contact Person Email
ewa.malecka-panas@umed.lodz.pl
Site Name
Therapia Nova Sp. z o.o.
Department Name
Therapia Nova
Principal Investigator Name
Jacek Wójtowicz
Principal Investigator Email
kontakt.therapianova@gmail.com
Contact Person Name
Jacek Wójtowicz
Contact Person Email
kontakt.therapianova@gmail.com
Site Name
Gastromed Sp. z o.o. (Torun)
Principal Investigator Name
Marcin Zmudziński
Principal Investigator Email
m.zmudek2@gmail.com
Contact Person Name
Marcin Zmudziński
Contact Person Email
m.zmudek2@gmail.com
Site Name
Osrodek Badan Klinicznych CLINSANTE S. C
Principal Investigator Name
Michał Walczak
Principal Investigator Email
michal.walczak@clinsante.pl
Contact Person Name
Michał Walczak
Contact Person Email
michal.walczak@clinsante.pl
Site Name
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.
Department Name
NZOZ CENTRUM MEDYCZNE KERmed
Principal Investigator Name
Patryk Korga
Principal Investigator Email
patryk.korga@kermed.pl
Contact Person Name
Patryk Korga
Contact Person Email
patryk.korga@kermed.pl
Site Name
Centrum Medyczne Oporow
Principal Investigator Name
Radosław Kempiński
Principal Investigator Email
radoslaw.kempinski@cmoporow.com
Contact Person Name
Radosław Kempiński
Site Name
Nowe Zdrowie-Ck Kieltucki I Wspolnicy Sp. j.
Principal Investigator Name
Jacek Kiełtucki
Principal Investigator Email
jacek.kieltucki@nowezdrowie-ck.pl
Contact Person Name
Jacek Kiełtucki
Site Name
Futuremeds Sp. z o.o. (Targówek)
Department Name
FutureMeds Targówek
Principal Investigator Name
Magda Fliszkiewicz
Principal Investigator Email
magda.fliszkiewicz@futuremeds.com
Contact Person Name
Magda Fliszkiewicz
Site Name
Synexus Polska Sp. z o.o. (Katowice)
Department Name
Oddział w Katowicach
Principal Investigator Name
Magdalena Olszanecka-Glinianowicz
Principal Investigator Email
magdalena.og@trailmed.com
Contact Person Name
Magdalena Olszanecka-Glinianowicz
Contact Person Email
magdalena.og@trailmed.com
Site Name
Wielkopolskie Centrum Medyczne Sp. z o.o.
Department Name
Szpital Św. Wojciecha; Poradania Gastroenterologiczna
Principal Investigator Name
Bartosz Cybułka
Principal Investigator Email
sekretariat@szpitalswwojciecha.pl
Contact Person Name
Bartosz Cybułka
Site Name
Zaniewski Bilski Sp. z o.o.
Department Name
Przychodnia Medicus filia w Olsztynie
Principal Investigator Name
Anna Woś- Zaniewska
Principal Investigator Email
kontakt@medicusolsztyn.pl
Contact Person Name
Anna Woś- Zaniewska
Contact Person Email
kontakt@medicusolsztyn.pl
Site Name
Futuremeds Sp. z o.o. (Krakow)
Department Name
FutureMeds Kraków
Principal Investigator Name
Ewelina Malec
Principal Investigator Email
ewelina.malec@futuremeds.com
Contact Person Name
Ewelina Malec
Contact Person Email
ewelina.malec@futuremeds.com
Site Name
Szpital Miejski Sw. Jana Pawla II W Elblagu
Department Name
Oddział Chorób Wewnętrznych
Principal Investigator Name
Krzysztof Niezgoda
Principal Investigator Email
sekretariat-wew@szpitalmiejski.elblag.pl
Contact Person Name
Krzysztof Niezgoda
Site Name
Szpital Czerniakowski Sp. z o.o.
Department Name
Oddział Chorób Wewnętrznych
Principal Investigator Name
Kamil Wrzosek
Principal Investigator Email
kwrzosek07@gmail.com
Contact Person Name
Kamil Wrzosek
Contact Person Email
kwrzosek07@gmail.com
Site Name
Jst Sp. z o.o.
Department Name
Centrum Medyczne Klara
Principal Investigator Name
Zofia Jamrozik- Kruk
Principal Investigator Email
komorki@cm-klara.pl
Contact Person Name
Zofia Jamrozik- Kruk
Contact Person Email
komorki@cm-klara.pl
Site Name
Synexus Polska Sp. z o.o. (Poznan)
Department Name
Oddział w Poznaniu
Principal Investigator Name
Magdalena Andrzejewska
Principal Investigator Email
magdalena.andrzejewska@trailmed.com
Contact Person Name
Magdalena Andrzejewska
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
Zakład Endoskopii NSSU
Principal Investigator Name
Michał Kukla
Principal Investigator Email
mkukla@su.krakow.pl
Contact Person Name
Michał Kukla
Contact Person Email
mkukla@su.krakow.pl
Site Name
Vita Longa Sp. z o.o.
Department Name
NZOZ "Vita Longa" Sp. z o.o.
Principal Investigator Name
Przemysław Ramos
Principal Investigator Email
przemyslaw.ramos@researchsolutions.pl
Contact Person Name
Przemysław Ramos
Site Name
Bonifraterskie Centrum Medyczne Sp. z o.o.
Department Name
Szpital Zakonu Bonifratrów św. Jana Bożego w Łodzi; Dział Endoskopii
Principal Investigator Name
Wojciech Piotrowski
Principal Investigator Email
wojtekp4@wp.pl
Contact Person Name
Wojciech Piotrowski
Contact Person Email
wojtekp4@wp.pl
Site Name
EMC Instytut Medyczny S.A.
Department Name
Prywatna Lecznica "Certus" Szpital Nr 1, Prywatna Lecznica Certus Ambulatoria
Principal Investigator Name
Piotr Szabłowski
Principal Investigator Email
szapi@mp.pl
Contact Person Name
Piotr Szabłowski
Contact Person Email
szapi@mp.pl
Site Name
Gastromed Kralisz Romatowski Stachurska Sp. j.
Department Name
NZOZ Specjalistyczne Centrum Gastrologii GASTROMED
Principal Investigator Name
Jacek Romatowski
Principal Investigator Email
biuro@gastromed.info
Contact Person Name
Jacek Romatowski
Contact Person Email
biuro@gastromed.info

Sponsor

Primary sponsor

Full Name
Cinclus Pharma Holding AB (publ)
Organisation Type
Pharmaceutical company
Country Of Registered Address
Sweden

Contract research organisations

Name
Psi Cro AG
Responsibilities
Feasibility, Medical Monitoring, Translations, Trial Supply Management, Vendor Management

Third parties

  • {"country":"Switzerland","full_name":"Psi Cro AG","duties_or_roles":"Feasibility, Medical Monitoring, Translations, Trial Supply Management, Vendor Management (as listed in sponsor duties)","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Linaprazan glurate
Active Substance
LINAPRAZAN GLURATE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
prodAuthStatus=1 (as listed in productDictionaryInfo)
Dose Levels
High dose and Low dose arms described (exact mg not specified in English content)
Investigational Product Name
LANSOPRAZOLE
Active Substance
LANSOPRAZOLE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
prodAuthStatus=2 (as listed in productDictionaryInfo)

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