A Phase 3 interventional study of Remaxol (succinate + methionine + inosine + nicotinamide) and Ringer's Solution in Jaundice, Obstructive, sponsored by POLYSAN Scientific & Technological Pharmaceutical Company. Completed at 13 sites in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-14.
Sponsored by POLYSAN Scientific & Technological Pharmaceutical Company · Phase 3, Interventional, and Treatment
The purpose of this study is to assess the safety and efficacy of Remaxol (succinate + methionine + inosine + nicotinamide; POLYSAN Ltd., Russia) infusions at dose 400 and 800 ml to treat mechanical jaundice of non-tumor cause during the first week after surgery.
The study will be performed in in-hospital patients with obstructive jaundice cause by conditions other than tumor (predominantly by cholelithiasis; ICD-10 codes K80 and K83.1). The patients will be screened in the 15 days preceeding the appointed drainage surgery. The treatment will be started in the first 6 hours after the drainage surgery and continue for 7 days.
Following screening, patients who meet the inclusion criteria and have no criteria for exclusion will be randomly assigned into three study groups in the proportion of 1: 1: 1):
Group I: treatment with Remaxol 400 ml IV + Ringer solution 400 ml IV for 7 days.
Group II: treatment with Remaxol 800 ml IV for 7 days. Group III (control): Ringer solution 800 ml IV for 7 days.
Physical examination data, vital signs, biochemistry panel (including bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, GGTP) will be assessed on days 1-8, on day 11 and day 14.
Diagnostic abdominal ultrasound will be performed before surgery and on days 3 and 8.
Neurophysiological test for the evaluation of the degree of encephalopathy will be performed before surgery, on days 3, 5, 8, and 14.
All patients will be followed up for 14 days.
Laboratory data corresponding to the following cutoff limits :
Exclusion Criteria:
Group I: treatment with Remaxol 400 ml IV + Ringer solution 400 ml IV for 7 days. Drug: Remaxol (succinate + methionine + inosine + nicotinamide)
Drug: Remaxol (succinate + methionine + inosine + nicotinamide) · Drug: Ringer's Solution
Group II: treatment with Remaxol 800 ml IV for 7 days. Drug: Remaxol (succinate + methionine + inosine + nicotinamide)
Drug: Remaxol (succinate + methionine + inosine + nicotinamide)
Group III: 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®
Intravenous infusion, 400 or 800 ml
Also known as: Placebo
Days to regression of jaundice
Time (days) from the date of drainage surgery to the reduction of the total bilirubin level down to 50 μmol / l, in experimental (Remaxol®) and control (Placebo) groups
Time frame: 14 days
Disappearance of cytolysis (normal alanine aminotransferase and aspartate aminotransferase serum levels) on day 5
Proportion of patients in study groups who reached normal serum levels of alanine aminotransferase and aspartate aminotransferase on day 5 from the start of treatment
Time frame: 5 days
Disappearance of cholestasis on day 5
Proportion of patients in study groups who reached normal serum levels of alkaline phosphatase, GGTP, total bilirubin, and direct bilirubin on day 5 from the start of treatment
Time frame: 5 days
Disappearance of encephalopathy on day 5
Proportion of patients in study groups who had normal brain functioning on day 5, as reflected by the neurophysiological test for the evaluation of the degree of encephalopathy
Time frame: 5 days
Serum bilirubin
Dynamics of total and direct bilirubin serum levels against baseline values and between visits in the study groups
Time frame: 14 days
Serum enzymes
Dynamics of serum alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and GGTP against baseline values and between visits in the study groups
Time frame: 14 days
Liver function
State of liver protein synthesis function (as reflected by serum levels of total protein, albumin, fibrinogen) against baseline values and/or between visits
Time frame: 14 days
Kidney function
State of kidney function (serum creatinine) against baseline values and/or between visits
Time frame: 14 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: 14 days
Plan to share: No
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POLYSAN Scientific & Technological Pharmaceutical Company