A Phase 3 interventional study of Remaxol® and Ringer's Solution in Jaundice; Malignant, sponsored by POLYSAN Scientific & Technological Pharmaceutical Company. Completed at 18 sites in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-10.
Sponsored by POLYSAN Scientific & Technological Pharmaceutical Company · Phase 3, Interventional, and Treatment
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).
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:
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):
Assessment will include physical examination data, vital signs, blood tests (CBC, biochemistry - protein, albumin, AST, ALT, APG, GGTP, LDH, total bilirubin, direct bilirubin, amylase, glucose, electrolytes, creatinine, urea, uric acid, C -reactive protein, lipid profile; coagulogram; urine samples), ECOG assessment, repeated abdominal ultrasound, neurophysiological test for the evaluation of encephalopathy, record of bile volume by drainage (if applicable).
All patients will be followed up for 31 days.
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
Exclusion Criteria:
Treatment with Remaxol® 400 ml IV + Ringer solution 400 ml IV for 10 days. Drug: Remaxol (succinate + methionine + inosine + nicotinamide)
Drug: Remaxol® · Drug: Ringer's Solution
Treatment with Remaxol® 800 ml IV for 10 days. Drug: Remaxol (succinate + methionine + inosine + nicotinamide)
Drug: Remaxol®
Treatment with Ringer's solution 800 ml IV for 7 days. Drug: Ringer's solution
Drug: Ringer's Solution
Solution for intravenous infusions, containing succinate, methionine, inosine, and nicotinamide in 400 ml glass bottle
Also known as: Remaxol (succinate + methionine + inosine + nicotinamide)
Solution for intravenous infusion, 400 or 800 ml
Also known as: Placebo
Time to regression of jaundice
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
Time frame: 21 days
Regression of cytolysis (normal alanine aminotransferase and aspartate aminotransferase serum levels)
Proportion of patients in study groups who reached normal serum levels of alanine aminotransferase and aspartate aminotransferase on day 11 from the start of treatment
Time frame: 11 days
Regression of cholestasis
Proportion of patients in study groups who reached normal serum levels of alkaline phosphatase, GGTP, total bilirubin, and direct bilirubin on day 11 from the start of treatment
Time frame: 11 days
Regression of encephalopathy
Proportion of patients in study groups who had normal brain functioning on day 11, as reflected by the neurophysiological test for the evaluation of the degree of encephalopathy
Time frame: 11 days
Serum bilirubin
Dynamics of total and direct bilirubin serum levels against baseline values and between visits in the study groups
Time frame: 21 days
Serum alkaline phosphatase
Dynamics of serum alkaline phosphatase level against baseline values and between visits in the study groups
Time frame: 21 days
Serum GGTP
Dynamics of serum gamma-glutamyltranspeptidase level against baseline values and between visits in the study groups
Time frame: 21 days
Serum alanine aminotransferase
Dynamics of serum alanine aminotransferase level against baseline values and between visits in the study groups
Time frame: 21 days
Serum aspartate aminotransferase
Dynamics of serum aspartate aminotransferase level against baseline values and between visits in the study groups
Time frame: 21 days
Liver function
State of liver protein synthesis function (as reflected by serum levels of total protein, albumin, INR, PT, PTI, APTT, fibrinogen) against baseline values and/or between visits
Time frame: 21 days
Kidney function
State of kidney function (creatinine serum level) against baseline values and/or between visits
Time frame: 21 days
Proportion of patients with complications of jaundice
The number of patients in the study groups who developed complications in the postoperative period which were, according to the researcher's assessment, causally related to the obstructive jaundice (for example, purulent cholangitis, sepsis, kidney failure)
Time frame: 21 days
Eastern Cooperative Oncology Group (ECOG) Performance Status
Status of patients in the study groups by ECOG (Eastern Cooperative Oncology Group) grades at the end of the study. ECOG Performance Status consists of the following grades: 0 - fully active, able to carry on all pre-disease performance without restriction; 1. - restricted but ambulatory and able to carry out work of a light or sedentary nature; 2. - ambulatory and capable of all selfcare but unable to carry out any work activities; 3. - capable of only limited selfcare; partially confined to bed or chair; 4. - completely disabled; cannot carry on any selfcare; 5. - Dead
Time frame: 31 days
Plan to share: No
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POLYSAN Scientific & Technological Pharmaceutical Company