Stop of proton-pump inhibitor treatment in patients with liver cirrhosis – a doubleblind, placebo-controlled trial (STOPPIT)

Phase 1

Recruiting

• Conditions: iver cirrhosis; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: CTIS2023-509863-26-00
• Lead Sponsor: niversity Medical Center Hamburg-Eppendorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-06
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 476

Inclusion Criteria

Male or female adult (18 years) patient., Provided written informed consent., Liver cirrhosis (diagnosed either histologically or by a combination of clinical, laboratory and/or radiological signs)., Hospitalized or recently hospitalized (0 to 42 days before baseline) with complicated liver cirrhosis., PPI treatment for at least 28 days prior to screening, PPI treatment with a single standard dose/day or less for a minimum of 7 days prior to screening., Females/Males who agree to comply with the applicable contraceptive requirements of the protocol., Non-pregnant, non-lactating females., 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., The patient is co-operative and available for the entire study.

Exclusion Criteria

Severe esophageal reflux disease (LA grade C or D) diagnosed by esophago-gastro-duodenoscopy (EGD) < 2 months prior to screening without PPI treatment for at least 8 weeks prior to screening., 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 or for up to 5 days after the last scheduled dose of IMP., Peptic ulcers diagnosed by EGD < 28 days prior to screening., Endoscopic therapy for varices < 14 days prior to screening., Life-expectancy < 1 year (at the discretion of the investigator) due to extrahepatic malignancies, metastasized hepatocellular carcinoma (HCC), or other severe extrahepatic-diseases. Importantly, HCC without extrahepatic metastases or a reduced life-expectancy < 1 year due to liver cirrhosis are not regarded as exclusion criteria., Regular intake of non-steroidal anti-inflammatory drugs on a daily basis with the exemption of acetylsalicylic acid in a dosage of up to 100mg/day., Patients with one or more of the following measurements at the time of screening or documented during 48 hours before screening: a. Body temperature > 38.5°C, or b. systolic blood pressure < 90 mmHg and tachycardia > 100 beats per minute, or c. ongoing catecholamine treatment higher than low dose norepinephrine ( 0.1 µg/kg/minute) (NB: terlipressin treatment for possible hepatorenal syndrome is not regarded as an exclusion criterion), or d. respiratory rate 22/minute., Hypersensitivity or intolerance to esomeprazole, substituted benzimidazoles or other excipients of the investigational medicinal product (IMP; Nexium mups or Placebo)., Ongoing therapy with nelfinavir., Participating 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 receive the first dose within this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified