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Table 1 In- and exclusion criteria. Patients can be included in the trial, if they fulfil all the inclusion and none of the exclusion criteria

From: Stop of proton-pump inhibitor treatment in patients with liver cirrhosis (STOPPIT): study protocol for a prospective, multicentre, controlled, randomized, double-blind trial

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.

  1. EGD oesophago-gastro-duodenoscopy, PPI proton-pump inhibitors, HCC hepatocellular carcinoma, NSAID non-steroidal anti-inflammatory drugs, ASA acetylsalicylic acid, IMP investigational medicinal product