Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

COMPLETED

NCT05055128

PHASE2

A Study in Patients With Erosive Esophagitis to Investigate Safety, Tolerability, and Healing Rates After 4 Weeks Treatment of X842 or Lansoprazole and Symptom Pattern During Subsequent 4 Weeks Treatment With Lansoprazole

Sponsor: Cinclus Pharma Holding AB

View on ClinicalTrials.gov

Summary

This study will be conducted in patients with erosive esophagitis due to gastro-esophageal reflux disease (GERD) Los Angeles (LA) grades C or D, and in patients with at least partial symptom response but still endoscopically unhealed (LA grades A or B) after 8 weeks history of standard treatment healing course with PPI, designed to support dose selection for Phase 3 and to investigate safety, tolerability, and healing rates after 4 weeks treatment of X842 or Lansoprazole, and symptom pattern during subsequent 4 weeks treatment with Lansoprazole.

Official title: A Randomized Double-blind, Double Dummy, Active Comparator-controlled Dose-finding Study in Patients With Erosive Esophagitis Due to Gastro-esophageal Reflux Disease (GERD) Los Angeles Grade C or D, and Patients With at Least Partial Symptom Response But Endoscopically Still Unhealed After 8 Weeks History of Standard Treatment Healing Course With Proton-pump Inhibitor (PPI), to Investigate Safety, Tolerability, and Healing Rates After 4 Weeks Treatment of X842 or Lansoprazole, and Symptom Pattern During Subsequent 4 Weeks Treatment With Lansoprazole

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

248

Start Date

2021-08-11

Completion Date

2022-09-01

Last Updated

2026-07-01

Healthy Volunteers

Conditions

Erosive Esophagitis

Interventions

DRUG

X842

Patients will receive X842 tablets.

DRUG

X842 Dummy

Patients will receive matching placebo tablets for X842.

DRUG

Lansoprazole

Patients will receive Lansoprazole capsule.

DRUG

Lansoprazole Dummy

Patients will receive matching placebo capsules for Lansoprazole.

Inclusion Criteria: 1. Body mass index (BMI) ≥ 18 and ≤ 40 kg/m\^2 at screening. 2. Gastro-esophageal reflux disease with endoscopically confirmed esophagitis: * LA grade C or D ≤7 days before randomization (with or without historical PPI treatment) or * LA grade A or B ≤7 days before randomization and history of treatment with the standard healing course of PPI for minimum of 8 weeks prior to screening and ≤7 days of non-treatment during this period and at least partial symptom response during the minimum of 8 weeks of PPI treatment. 3. Willing and able to comply with all aspects of the protocol (including capsule swallowing, diary completion, etc.). 4. Capable of signing informed consent form. Exclusion Criteria: 1. History or presence of any clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disease or disorder. 2. Patients with so-called "alarm features" in symptomatology, like odynophagia, severe dysphagia, bleeding, weight loss, anemia, and blood in stool pointing to a possible malignant disease of the gastrointestinal (GI) tract. 3. Present clinically significant psychiatric diagnosis. 4. History of malignancy of any organ system. 5. Presence of esophageal ulcer, stricture, Barrett´s esophagus or suspected esophagitis secondary to infection, inflammatory disease, ingestion of erosive chemicals or history of any surgical or medical condition which might significantly alter the Gastro-oesophageal reflux disease (GERD) status or the absorption, distribution, metabolism or excretion of drugs. 6. Known severe atrophic gastritis. 7. Any planned major surgery within the duration of the study. 8. History of a positive result for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), antibody to Hepatitis B core antigen (anti-HBcAg), or antibody to Hepatitis C virus (anti-HCV) or presence of these findings on screening. 9. History of long QTc syndrome (e.g. QTc ≥450 ms for males and ≥470 ms for females). 10. Cardiac arrhythmias or any clinically significant abnormalities in the resting 12-lead ECG at the time of screening, as judged by the Investigator. 11. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity. 12. Current or history of alcohol, drug abuse and/or use of anabolic steroids within 2 years prior to screening. 13. Women who are pregnant or breastfeeding. 14. Patients who have previously participated (completed or withdrawn) in this study CX842A2201.

Locations (42)

Genesis Clinical Research - Tampa

Tampa, Florida, United States

Medical Centre Asklepii

Dupnitsa, Dupnitsa, Bulgaria

Medical Center Medconsult Pleven

Pleven, Pleven, Bulgaria

DCC-1 Sliven

Plovdiv, Plovdiv, Bulgaria

MHAT "Kaspela"

Plovdiv, Plovdiv, Bulgaria

Medical Center Prolet EOOD

Rousse, Ruse, Bulgaria

Diagnostive Consultative Center-1 Sliven

Sliven, Sliven, Bulgaria

Medical Center Hera - Gastroenterology office

Sliven, Sliven, Bulgaria

2-nd MHAT

Sofia, Sofia, Bulgaria

Medical Center Excelsior

Sofia, Sofia, Bulgaria

MHAT "Sveti Ivan Rilski" - Sofia

Sofia, Sofia, Bulgaria

Medical Center Hera - Gastroenterology office

Sofia, Sofia, Bulgaria

Medical Center Excelsior

Sofia, Sofia-Grad, Bulgaria

DCC XIV Sofia

Sofia, Sofia-Grad, Bulgaria

DCC XIV Sofia

Sofia, Sofia-Grad, Bulgaria

Medical Center New Rehabilitation Center EOOD

Stara Zagora, Stara Zagora, Bulgaria

Mhat "Hristo Botev"

Vratsa, Vratsa, Bulgaria

Medical Center "Biomed 99" Ltd

Vidin, Bulgaria

ResTrial GastroEndo s.r.o.

Prague, Czechia

LTD"Brothers"

Batumi, Adjara, Georgia

A. Aladashvili clinic LLC

Tbilisi, K'alak'i T'bilisi, Georgia

LTD Israeli-Georgian Medical Research Clinic "Helsicore"

Tbilisi, K'alak'i T'bilisi, Georgia

LTD TSMU and Ingorokva High Medical Technology University Clinic

Tbilisi, K'alak'i T'bilisi, Georgia

Emergency Cardiology Center named by acad. G. Chapidze

Tbilisi, K'alak'i T'bilisi, Georgia

Bekes Megyei Kozponti Korhaz, Dr.Rethy Pal Tagkorhaz

Békéscsaba, Bekes County, Hungary

Pannonia Maganorvosi Centrum Kft

Budapest, Budapest, Hungary

Szegedi Tudomanyegyetem Általános Orvostudományi Kar

Szeged, Csongrád megye, Hungary

ClinExpert Kft.

Budapest, Pest County, Hungary

NZOZ "Centrum Medyczne KERMED"

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Centrum Medyczne Melita Medical

Wroclaw, Lower Silesian Voivodeship, Poland

Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi

Lodz, Lódzkie, Poland

Oswiecimskie Centrum Badan Klinicznych Medicome Sp. z o.o.

Oświęcim, Poland

ETG Skierniewice

Skierniewice, Poland

Twoja Przychodnia - Szczecinskie Centrum Medyczne

Szczecin, Poland

EuroMediCare Szpital Specjalistyczny z Przychodnia

Wroclaw, Poland

EuroMediCare Szpital Specjalistyczny z Przychodnia

Wroclaw, Poland

ETG Zamosc

Zamość, Poland

Zvezdara University Medical Center

Belgrade, Belgrade, Serbia

Oblasna komunalna ustanova "Chernivetska oblasna klinichna likarnia"

Chernivtsi, Chernivtsi Oblast, Ukraine

KNP "Odeska oblasna klinichna likarnia" Odeskoi oblasnoi rady"

Odesa, Odesa Oblast, Ukraine

Medychnyi Tsentr TOV "KHELS KLINIK" - viddil Gasrtroenterology, Hepatology and Endocrinology

Vinnytsia, Vinnytsia Oblast, Ukraine

KU "6-A miska klinichna likarnia"

Zaporizhzhia, Zaporizhzhia Oblast, Ukraine

Clinical Research Directory

A Study in Patients With Erosive Esophagitis to Investigate Safety, Tolerability, and Healing Rates After 4 Weeks Treatment of X842 or Lansoprazole and Symptom Pattern During Subsequent 4 Weeks Treatment With Lansoprazole

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (42)