Stop of proton-pump inhibitor treatment in patients with liver cirrhosis - a double-blind, placebo-controlled trial
- Conditions
- K74K65R18K72K72.79R17A49K76.7Fibrosis and cirrhosis of liverPeritonitis
- Registration Number
- DRKS00021290
- Lead Sponsor
- niversitätsklinikum Hamburg-Eppendorf
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 476
1. Male or female patient, at least 18 years old.
2. Patients with liver cirrhosis (diagnosed either histologically or by a combination of clinical, laboratory and/or radiological signs).
3. Hospitalized or recently hospitalized (0 to 42 days before baseline) with complicated liver cirrhosis.
4. Treatment with proton pump inhibitors (PPI) for at least 28 days prior to screening.
5. PPI treatment with a single standard dose/day or less for at least 7 days prior to screening.
6. Females/males who agree to comply with the applicable contraceptive requirements of the protocol.
7. Non-pregnant, non-lactating females.
8. 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.
9. The patient is co-operative and available for the entire study.
10. Provided written informed consent.
1. Severe reflux esophagitis (LA grade C or D) diagnosed by EGD < 2 months prior to screening without PPI-therapy for at least 8 weeks prior to the screening visit.
2. Peptic ulcers diagnosed by EGD < 28 days prior to screening.
3. Endoscopic therapy for esophageal varices < 14 days prior to screening.
4. Life-expectancy < 1 year (at the discretion of the investigator) due to extrahepatic malignancies, metastasized hepatocellular carcinoma (HCC), or other severe extrahepatic diseases. HCC without extrahepatic metastases or a reduced life-expectancy < 1 year due to liver cirrhosis are not regarded as exclusion criteria.
5. Regular intake of non-steroidal anti-inflammatory drugs on a daily basis with the exemption of acetylsalicylic acid 100mg/day.
6. Patients with one or more of the following measurements at screening or documented 48 hours before screening:
a) Body temperature > 38.5°C, or
b) systolic blood pressure < 90mmHg and tachycardia > 100 bpm, or
c) ongoing catecholamine treatment higher than low dose norepinephrine (max. 0.1 µg/kg/minute allowed; terlipressin for possible hepatorenal syndrome is allowed, too), or
d) respiratory rate of 22/minute or higher.
7. Hypersensitivity or intolerance to esomeprazole, substituted benzimidazoles or other excipients of the IMP.
8. Ongoing therapy with nelfinavir.
9. Participation in a clinical trial or use of an IMP within 30 days or five times the half-life of the IMP - whichever is longer - prior to receiving the first dose within this study.
10. Positive urine pregnancy test at screening or positive serum pregnancy test before the first treatment or is breast feeding.
11. Patient is not willing to use adequate contraceptive precautions during the study and for up to 5 days after the last scheduled dose of IMP.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to first unplanned re-hospitalization* or death (whatever occurs first) within 12 months (360 days) after randomization (composite endpoint).<br>* Exception: expected re-hospitalization for paracentesis during a period of 30 days after discharge of patients with a history of refractory ascites (without any other complication of cirrhosis) is not defined as an unplanned re-hospitalization” with regard to the primary endpoint criteria.<br>
- Secondary Outcome Measures
Name Time Method