DRKS00021290招募中3 期
Stop of proton-pump inhibitor treatment in patients with liver cirrhosis - a double-blind, placebo-controlled trial - STOPPIT
niversitätsklinikum Hamburg-Eppendorf0 个研究点目标入组 476 人开始时间: 2021年3月12日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 476
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
研究者
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