Remaxol® in Mechanical Jaundice of Non-malignant Origin (NCT03418935) | Clinical Trial Compass
CompletedPhase 3
Remaxol® in Mechanical Jaundice of Non-malignant Origin
Russia342 participantsStarted 2017-04-03
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
âś“. Presence of signed informed consent for participation in the study.
âś“. Men and women over the age of 18 (incl.).
âś“. Obstructive jaundice, verified by enlargement of intrahepatic bile ducts with proven non-tumor obstruction of extrahepatic bile ducts.
âś“. Duration of mechanical jaundice 15 days or less.
âś“. The level of total bilirubin in the blood from 5-fold to 20-fold exceeding normal.
âś“. Laboratory data corresponding to the following cutoff limits :
âś“. Negative urine test for pregnancy in women of reproductive age.
âś“. Consent to use adequate methods of contraception or for complete abstinence from sexual activity for the period of the study.
Exclusion criteria
âś•. Tumor causing the obstruction of the bile ducts or the presence of any other malignancy at the time of randomization.
âś•. The need for another radical surgery within 2 weeks from the planned date of randomization.
âś•. Acute destructive pancreatitis, diffuse or diffuse peritonitis, sepsis.
âś•. Preexisting liver cirrhosis.
âś•. Exacerbation of the chronic peptic ulcer.
What they're measuring
1
Days to regression of jaundice
Timeframe: 14 days
Trial details
NCT IDNCT03418935
SponsorPOLYSAN Scientific & Technological Pharmaceutical Company
âś•. 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.