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Stop of proton-pump inhibitor treatment in patients with liver cirrhosis – a doubleblind, placebo-controlled trial (STOPPIT)
EU CTIS ID: 2023-509863-26-00
What this study is testing
To determine the time to first unplanned re-hospitalization or death (composite endpoint) in patients with liver cirrhosis who discontinue long-term proton-pump inhibitor (PPI) therapy (intervention group) as compared to patients who continue PPI therapy (control group) over a period of 12 months (360 days).
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.