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

Completed · Phase 2 · Has a placebo group

Conditions studied: Erosive Esophagitis

In brief

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.

Key facts

Study ID: NCT05055128
Run by: Cinclus Pharma Holding AB
People needed: 248
Starts: 2021-08-11
Expected to finish: 2022-09-01
Last updated by the study team: 2026-07-01

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Body mass index (BMI) ≥ 18 and ≤ 40 kg/m\^2 at screening.
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.
Willing and able to comply with all aspects of the protocol (including capsule swallowing, diary completion, etc.).
Capable of signing informed consent form.

You may not qualify if…

History or presence of any clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disease or disorder.
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.
Present clinically significant psychiatric diagnosis.
History of malignancy of any organ system.
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.
Known severe atrophic gastritis.
Any planned major surgery within the duration of the study.
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.
History of long QTc syndrome (e.g. QTc ≥450 ms for males and ≥470 ms for females).
Cardiac arrhythmias or any clinically significant abnormalities in the resting 12-lead ECG at the time of screening, as judged by the Investigator.
History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity.
Current or history of alcohol, drug abuse and/or use of anabolic steroids within 2 years prior to screening.
Women who are pregnant or breastfeeding.
Patients who have previously participated (completed or withdrawn) in this study CX842A2201.

Where it is running

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

Full record on ClinicalTrials.gov

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