Remaxol® in Malignant Mechanical Jaundice (NCT03416062) | Clinical Trial Compass
CompletedPhase 3
Remaxol® in Malignant Mechanical Jaundice
Russia240 participantsStarted 2017-04-03
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 0-2.
✓. Life expectancy of more than 3 months.
✓. Laboratory data corresponding to the following cutoff limits :
✓. Negative urine test for pregnancy in women of reproductive age.
Exclusion criteria
✕. 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).
What they're measuring
1
Time to regression of jaundice
Timeframe: 21 days
Trial details
NCT IDNCT03416062
SponsorPOLYSAN Scientific & Technological Pharmaceutical Company
✕. 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.