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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Presence of signed informed consent for participation in the study.
. Men and women over the age of 18 (incl.).
. Obstructive jaundice, verified by enlargement of intrahepatic bile ducts with proven non-tumor obstruction of extrahepatic bile ducts.
. Duration of mechanical jaundice 15 days or less.
. The level of total bilirubin in the blood from 5-fold to 20-fold exceeding normal.
. Laboratory data corresponding to the following cutoff limits :
. Negative urine test for pregnancy in women of reproductive age.
. Consent to use adequate methods of contraception or for complete abstinence from sexual activity for the period of the study.
Exclusion criteria
. Tumor causing the obstruction of the bile ducts or the presence of any other malignancy at the time of randomization.
. The need for another radical surgery within 2 weeks from the planned date of randomization.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Days to regression of jaundice
Timeframe: 14 days
Trial details
NCT IDNCT03418935
SponsorPOLYSAN Scientific & Technological Pharmaceutical Company
. Acute destructive pancreatitis, diffuse or diffuse peritonitis, sepsis.
. Preexisting liver cirrhosis.
. Exacerbation of the chronic peptic ulcer.
. Ongoing bleeding.
. 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.