Inclusion criteria | Exclusion criteria |
---|---|
Male and female patients, at least 18 years old. | Diagnosis of reflux esophagitis LA grade C or D by EGD < 2 months prior to the screening visit without PPI therapy for at least 8 weeks prior to the screening visit. |
Patients with liver cirrhosis. The diagnosis of liver cirrhosis may be based on (i) histology or (ii) a combination of clinical, laboratory and radiological criteria. | Peptic ulcers diagnosed by EGD < 28 days prior to the screening visit. |
Hospitalization or recent hospitalization (0 to 42 days prior to the baseline visit) with complications of liver cirrhosis. | History of endoscopic therapy for oesophageal varices < 14 days prior to the screening visit. |
Treatment with PPI for at least 28 days prior to screening. | Life-expectancy < 1 year (at the discretion of the investigator) due to extrahepatic malignancies, metastasized HCC, or other severe extrahepatic diseases (HCC without extrahepatic metastases or reduced life-expectancy < 1 year due to cirrhosis are not regarded as exclusion criteria). |
Treatment with a PPI single standard dose/day or less for at least 7 days prior to screening. | Regular intake of NSAID on a daily basis (except for ASA 100 mg/day orally) |
Females/males who agree to comply with the applicable contraceptive requirements. | One or more of the following measurements at the time of screening or documented up to 48 h before: ● Temperature > 38.5 °C ● Systolic blood pressure < 90 mmHg and heart rate > 100 bpm ● Catecholamine treatment > 0.1 μg/kg/min (terlipressin is allowed) ● Respiratory rate ≥ 22/min |
Non-pregnant, non-lactating females. | Hypersensitivity or intolerance to esomeprazole, substituted benzimidazoles or other excipients of the IMP. |
Ability to understand the patient information and to personally sign and date the informed consent to participate in the study, before completing any study-related procedures. | Ongoing therapy with nelfinavir. |
The patient is co-operative and available for the entire study. | Participation in a clinical trial or use of an IMP within 30 days or five times the half-live of the IMP—whichever is longer—prior to receiving the first dose within this study. |
Provided written informed consent. | Positive urine pregnancy test at screening or positive serum pregnancy test before the first treatment or is breast feeding. |
Patient is not willing to use adequate contraceptive precautions during the study and up for 5 days after the last scheduled dose of IMP. |