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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-518714-31-00 | EU Trial (CTIS) Number | ||
| UTN U1111-1315-2237 | Other Identifier | World Health Organization |
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The goal of this clinical trial is to find out how well linaprazan glurate can heal erosive esophagitis (EE) caused by gastroesophageal reflux disease (GERD), compared to lansoprazole, a commonly used medication. Researchers will also evaluate whether linaprazan glurate:
Participants must be between 18 to 80 years old and have EE due to GERD confirmed by an endoscopy. Participants cannot join if they have an active Helicobacter pylori (HP) infection or were treated for HP in the past 6 weeks or have taken antibiotics or bismuth-containing drugs in the past 6 weeks.
The study is a randomized, double-blind, active comparator-controlled trial lasting up to 4 months. Randomized means that participants are assigned by chance (like flipping a coin) to one of the treatment groups and double-blind means neither the participants nor the study team will know which treatment is given. Participants will be placed into one of three groups (about 167 people in each group):
Everyone will take 2 tablets and 1 capsule by mouth daily for 8 weeks. Some tablets or capsules will be placebos (look like medicine but contain no active drug). Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Linaprazan glurate 50 mg BID | Experimental |
| |
| Group 2: Linaprazan glurate 50 mg QD | Experimental |
| |
| Group 3: Lansoprazole 30 mg QD | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linaprazan glurate 50 mg Twice Daily (BID) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Healing of EE at Week 4 as assessed by endoscopy in participants with Baseline EE LA grades C/D. | From enrollment to the end of treatment at 4 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
Ongoing infection with HP or diagnosis and treatment of HP infection within 6 weeks of randomization OR any treatment with antibiotics or bismuth containing drugs within 6 weeks of randomization.
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 study, or influence the study results or the participant's ability to participate in the study. The following examples are conditions that would exclude the patient from participating:
History of malignancy of any organ system (other than completely treated localized basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin or in situ cervical carcinoma), within the past 5 years.
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*; a history of radiation therapy, radiofrequency ablation, endoscopic mucosal resection, or cryotherapy to the esophagus; or any history of caustic or physiochemical trauma.
*Note: Patients with diagnosis of Schatzki's ring (mucosal tissue ring around lower esophageal sphincter) are eligible to participate, unless history of dilatation within 3 months of Screening.
History of any surgical or medical condition which might significantly alter the GERD status or the absorption, distribution, metabolism, or excretion of drugs. The Investigator is to be guided by evidence of any of the following: history of major GI surgery such as gastrectomy, gastroenterostomy, any bariatric surgery, bowel resection, or transjugular intrahepatic portosystemic shunt. Nissen fundoplication is not exclusionary as long as the patient is eligible according to other criteria.
Known severe atrophic gastritis as assessed from medical history or upper endoscopy during Screening.
Zollinger-Ellison syndrome or other gastric acid hypersecretory conditions.
History of treatment course with lansoprazole within 2 months prior to Screening.
Current peptic ulcer.
Body mass index (BMI) ≤ 18 and ≥ 40 kg/m² at Screening.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rikard Reneland, MD, PhD | Contact | +46 70 300 40 88 | rikard.reneland@cincluspharma.com | |
| Kajsa Larsson, MD, PhD | Contact | +46 70 675 01 28 | kajsa.larsson@cincluspharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski - 2003" OOD | Not yet recruiting | Dupnitsa | Dupnitsa | 2600 | Bulgaria |
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|
| Linaprazan Glurate 50 mg Once Daily (QD) | Drug | 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. |
|
| Lansoprazole 30 mg Once Daily (QD) | Drug | 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. |
|
| Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD | Recruiting | Gorna Oryahovitsa | Gorna Oryahovitsa | 5100 | Bulgaria |
| Diagnosis - Consulting Centre 1 | Not yet recruiting | Sliven | Sliven | Bulgaria |
| Medical Center "Orange" | Not yet recruiting | Sofia | Sofia City Province | 1343 | Bulgaria |
| Multiprofile Hospital for Active Treatment - "Vita" | Not yet recruiting | Sofia | Sofia City Province | 1407 | Bulgaria |
| Diagnostic and Consulting Center Alexandrovska | Recruiting | Sofia | Sofia City Province | 1431 | Bulgaria |
| Diagnostic Consultative Center - Focus-5 | Not yet recruiting | Sofia | Sofia City Province | 1463 | Bulgaria |
| Medical Center Hera | Recruiting | Sofia | Sofia City Province | 1510 | Bulgaria |
| University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna - ISUL" | Not yet recruiting | Sofia | Sofia City Province | 1527 | Bulgaria |
| University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov | Not yet recruiting | Sofia | Sofia City Province | 1606 | Bulgaria |
| 20th Diagnostic Consultancy Center | Recruiting | Sofia | Sofia City Province | 1618 | Bulgaria |
| Medical Center Hera | Not yet recruiting | Kyustendil | 2500 | Bulgaria |
| University Multiprofile Hospital for Active Treatment "Sveta Marina" | Not yet recruiting | Pleven | 5800 | Bulgaria |
| Multiprofile Hospital for Active Treatment "Sveti Panteleymon" | Recruiting | Plovdiv | 4000 | Bulgaria |
| First Private Hospital Vratsa | Recruiting | Vratsa | 3000 | Bulgaria |
| Military Hospital Brno, Internal Department | Not yet recruiting | Brno | Brno | 615 00 | Czechia |
| SurGal Clinic s.r.o. | Not yet recruiting | Brno | 602 00 | Czechia |
| University Hospital Brno | Not yet recruiting | Brno | 625 00 | Czechia |
| PreventaMed s.r.o. | Not yet recruiting | Olomouc | 779 00 | Czechia |
| Gastromedic s.r.o. | Recruiting | Pardubice | 53003 | Czechia |
| Hospital Prachatice a.s. | Recruiting | Prachatice | 38301 | Czechia |
| Endohope Morava s.r.o. | Not yet recruiting | Zábřeh | 78901 | Czechia |
| Khozrevanidze's Clinic | Recruiting | Batumi | 6000 | Georgia |
| JSC Georgian Clinics | Not yet recruiting | Kutaisi | 4600 | Georgia |
| LTD Aversi Clinic | Not yet recruiting | Marneuli | 3000 | Georgia |
| LTD Krol Medical Corporation | Recruiting | Tbilisi | 0101 | Georgia |
| The New Hospitals | Not yet recruiting | Tbilisi | 0114 | Georgia |
| Israeli - Georgian Medical Research Clinic Healthycore LLC | Recruiting | Tbilisi | 0119 | Georgia |
| Janmrtelobis Sakhli LLC | Recruiting | Tbilisi | 0144 | Georgia |
| LLC Geo Hospitals | Not yet recruiting | Tbilisi | 0144 | Georgia |
| LTD Aversi Clinic | Recruiting | Tbilisi | 0160 | Georgia |
| LEPL The First University Clinic of Tbilisi State Medical University | Recruiting | Tbilisi | 0178 | Georgia |
| Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC | Not yet recruiting | Tbilisi | 0180 | Georgia |
| Diakonie Hospital | Not yet recruiting | Mannheim | Baden-Wurttemberg | 68163 | Germany |
| Medical Care Unit Dachau | Not yet recruiting | Dachau | Bavaria | 85221 | Germany |
| Clinic for Internal Medicine Munich-Sued | Not yet recruiting | Munich | Bavaria | 81379 | Germany |
| Bekes County Central Hospital Dr. Rethy Pal Member Hospital, 4th Department of Internal Medicine - Gastroenterology - Hepatology | Recruiting | Békéscsaba | H-5600 | Hungary |
| G1 Institute | Not yet recruiting | Budapest | 1036 | Hungary |
| Clinexpert Ltd. Budapest | Not yet recruiting | Budapest | H-1033 | Hungary |
| Obuda Healthcare Center Ltd. | Not yet recruiting | Budapest | H-1036 | Hungary |
| Synexus Hungary Ltd. | Not yet recruiting | Budapest | H-1036 | Hungary |
| Central Hospital of Northern Pest - Military Hospital, Department of Gastroenterology | Not yet recruiting | Budapest | H-1062 | Hungary |
| Main Railway Outpatient Clinic Debrecen, Department of Gastroenterology | Not yet recruiting | Debrecen | H-4025 | Hungary |
| Heves County Markhot Ferenc Teaching Hospital and Clinic, Department of General and Vascular Surgery | Not yet recruiting | Eger | H-3300 | Hungary |
| University of Szeged, Department of Internal Medicine- Western Site | Recruiting | Szeged | H-6720 | Hungary |
| Fejer County St. Gyorgy University Teaching Hospital, Department of Internal Medicine I | Not yet recruiting | Székesfehérvár | H-8000 | Hungary |
| Javorszky Odon Hospital Vac, Department of Gastroenterology | Recruiting | Vác | H-2600 | Hungary |
| NZOZ Specialist Gastrology Centre GASTROMED | Not yet recruiting | Bialystok | 15-322 | Poland |
| "MEDIS" Medical Center | Not yet recruiting | Bydgoszcz | 85-229 | Poland |
| NZOZ KERmed Medical Centre | Recruiting | Bydgoszcz | 85-231 | Poland |
| CLINSANTE Clinical Research Centre Ewa Galczak-Nowak, Malgorzata Trzaska | Not yet recruiting | Bydgoszcz | 85-794 | Poland |
| St. John Paul 2nd Municipal Hospital in Elblag, Department of Internal Diseases | Recruiting | Elblag | 82-300 | Poland |
| Synexus Polska Sp. z o.o. Branch in Gdansk | Recruiting | Gdansk | 80-382 | Poland |
| Synexus Polska Sp. z o.o. Branch in Katowice | Recruiting | Katowice | 40-040 | Poland |
| "Vita Longa" Non-Public Healthcare Facility, Limited Liability Company | Recruiting | Katowice | 40-748 | Poland |
| Independent Public Healthcare Facility University Hospital in Krakow, NSSU Endoscopy Department | Not yet recruiting | Krakow | 30-688 | Poland |
| FutureMeds Krakow | Not yet recruiting | Krakow | 31-501 | Poland |
| Independent Public Healthcare Facility, Norbert Barlicki University Teaching Hospital No. 1 of the Medical University in Lodz, Clinical Department of General Gastroenterology and Oncology | Not yet recruiting | Lodz | 90-153 | Poland |
| Hospital of Brothers Hospitallers of Saint John of God In Lodz, Endoscopy Lab | Not yet recruiting | Lodz | 93-357 | Poland |
| Oswiecim Clinical Trial Centre | Recruiting | Oświęcim | 32-600 | Poland |
| EMC Medical Institute Joint Stock Company, CERTUS Private Healthcare Facility Hospital No. 1, CERTUS Private Healthcare Facility Ambulatories | Not yet recruiting | Poznan | 60-309 | Poland |
| Synexus Polska Sp. z o.o. Branch in Poznan | Recruiting | Poznan | 60-702 | Poland |
| New health-CK, Kieltucki and partners g.p. | Recruiting | Staszów | 28-200 | Poland |
| Gastromed Sp. z o.o. (LLC) | Not yet recruiting | Torun | 87-100 | Poland |
| FutureMeds Warsaw Center | Not yet recruiting | Warsaw | 00-215 | Poland |
| Therapia Nova | Not yet recruiting | Warsaw | 01-595 | Poland |
| ETG Warszawa | Not yet recruiting | Warsaw | 02-677 | Poland |
| Futuremeds Targowek | Not yet recruiting | Warsaw | 03-291 | Poland |
| WIP Warsaw IBD Point Profesor Kierkus | Recruiting | Warsaw | 04-501 | Poland |
| Medical Centre Oporow | Not yet recruiting | Wroclaw | 52-416 | Poland |
| FutureMeds Wroclaw | Not yet recruiting | Wroclaw | 53-673 | Poland |
| ETG Zamosc | Recruiting | Zamość | 22-400 | Poland |
| Colentina Clinical Hospital, Department of Gastroenterology | Recruiting | Bucharest | 020125 | Romania |
| Cluj Napoca County Emergency Clinical Hospital, Internal Medicine III | Recruiting | Cluj-Napoca | 400006 | Romania |
| TVM MED SERV SRL, Medical Center for Gastroenterology, Hepatology and Digestive Endoscopy | Not yet recruiting | Cluj-Napoca | 400061 | Romania |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C494814 | BID protein, human |
| D064747 | Lansoprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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