NCT03416062已完成3 期
A Multicenter, Double-blind, Placebo-controlled, Randomized Trial of the Efficacy and Safety of Remaxol®, a Solution for Infusions Produced by STPF POLYSAN (Russia), in Patients With Malignant Mechanical Jaundice
POLYSAN Scientific & Technological Pharmaceutical Company18 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2017年4月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 18
- 主要终点
- Time to regression of jaundice
研究概览
简要总结
The trial intends to study the safety and efficacy of Remaxol® (succinate + methionine + inosine + nicotinamide; POLYSAN Ltd., Russia),solution for infusion for the reduction of hyperbilirubinemia in patients with obstructive jaundice caused by tumor (malignancy).
详细描述
The study will recruit in-hospital surgical patients with obstructive jaundice caused by malignancies of pancreatic and hepatobiliary zone.
The study consists of the following periods:
- Screening - preliminary examination of patients (duration up to 3 days).
- Period of therapy (including surgery and postoperative period) - treatment with the investigational product Remaxol®, solution for infusions, (NTFF POLYSAN Ltd., Russia) or placebo, as part of standard infusion therapy during the postoperative period of patients with mechanical jaundice of malignant origin (duration 10 days).
- The period of follow-up (duration - 3 weeks after the end of treatment).
After the screening, patients who meet the inclusion criteria and do not have exclusion criteria will be randomly assigned to three groups (1:1:1):
- Group I: treatment with Remaxol® 400 ml IV, and placebo (Ringer solution) 400 ml IV, once a day for 10 days, along with standard infusion therapy.
- Group II: treatment Remaxol® 800 ml IV, once a day for 10 days, along with standard infusion therapy.
- Group III: patients will receive placebo ((Ringer solution) 800 ml IV, once a day for 10 days, along with standard infusion therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of signed informed consent for participation in the study.
- •Men and women over 18 years of age (incl.).
- •Demonstrated by one or several instrumental methods (ultrasound, cholangiography, CT or MRI) enlargement of intrahepatic bile ducts with visualized obturation of the main bile ducts caused by tumor.
- •Duration of mechanical jaundice less than 30 days, including the first day of the screening period.
- •The status by the classifications Eastern Cooperative Oncology Group (ECOG) scale is 0-
- •Life expectancy of more than 3 months.
- •Laboratory data corresponding to the following cutoff limits :
- •hemoglobin ≥90 g / l; neutrophils ≥ 1.5x109 / l; Platelets ≥ 75 x 109 / L; AsAT and / or AlAT above 3 х normal but less than 25 х normal Serum creatinine not exceeding 2 × normal, Serum potassium within normal limits
- •Negative urine test for pregnancy in women of reproductive age.
- •For reproductive age: consent to use adequate methods of contraception or for complete abstinence from sexual activity for the period of the study.
排除标准
- •Radical surgery planned within 10 days from the date of randomization.
- •Liver metastases with the biliary block at the level of segmental ducts.
- •Suspicion of metastases in the central nervous system or metastatic arachnoiditis during physical examination; clinically significant ascites.
- •Acute destructive pancreatitis, diffuse peritonitis, ongoing bleeding of any etiology, sepsis (procalcitonin test of 10 ng / ml and above).
- •Liver cirrhosis
- •Presence of clinically significant cardiovascular diseases: chronic cardiac insufficiency III-IV functional class by NYHA, uncontrolled arterial hypertension, acute stroke or acute myocardial infarction in the previous 3 months, unstable angina, uncontrolled arrhythmia and severe heart rhythm disturbances.
- •Pregnancy or lactation.
- •Hypersensitivity to any component of the study drug / placebo and / or intolerance to any component of the study drug / placebo.
- •Regular intake of medications prohibited or not permitted by the study protocol within 4 weeks prior to enrollment or medical indication tio start any medication prohibited or not permitted by the study protocol
- •Concomitant chronic systemic immune or hormonal therapy.
- •Alcohol and/or drug dependence.
- •Active tuberculosis, HIV infection, syphilis, acute viral hepatitis.
- •Any other conditions / diseases that may interfere with the patient's compliance with the requirements of the Protocol.
- •Mental, physical and other reasons that do not allow the patient to comply with the requirements of the study protocol.
- •Any other significant (by judgement of the investigator) condition that prevents the patient from entering the study.
- •Participation in any clinical trial in the previous 3 months.
- •Staff of the research center and their family members.
研究组 & 干预措施
Remaxol® 400 ml + Placebo 400 ml
Experimental
Treatment with Remaxol® 400 ml IV + Ringer solution 400 ml IV for 10 days. Drug: Remaxol (succinate + methionine + inosine + nicotinamide)
干预措施: Remaxol® (Drug)
Remaxol® 400 ml + Placebo 400 ml
Experimental
Treatment with Remaxol® 400 ml IV + Ringer solution 400 ml IV for 10 days. Drug: Remaxol (succinate + methionine + inosine + nicotinamide)
干预措施: Ringer's Solution (Drug)
Remaxol® 800 ml
Experimental
Treatment with Remaxol® 800 ml IV for 10 days. Drug: Remaxol (succinate + methionine + inosine + nicotinamide)
干预措施: Remaxol® (Drug)
Control
Placebo Comparator
Treatment with Ringer's solution 800 ml IV for 7 days. Drug: Ringer's solution
干预措施: Ringer's Solution (Drug)
结局指标
主要结局
Time to regression of jaundice
时间窗: 21 days
The time (days) from the day of the drainage operation to the reduction of the total bilirubin level down to 90 μmol / l, in experimental (Remaxol®) vs. control (Placebo) groups
次要结局
- Serum bilirubin(21 days)
- Regression of cholestasis(11 days)
- Serum aspartate aminotransferase(21 days)
- Liver function(21 days)
- Kidney function(21 days)
- Eastern Cooperative Oncology Group (ECOG) Performance Status(31 days)
- Regression of cytolysis (normal alanine aminotransferase and aspartate aminotransferase serum levels)(11 days)
- Serum alanine aminotransferase(21 days)
- Regression of encephalopathy(11 days)
- Serum alkaline phosphatase(21 days)
- Serum GGTP(21 days)
- Proportion of patients with complications of jaundice(21 days)
研究者
研究点 (18)
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