Status:
COMPLETED
Remaxol® in Mechanical Jaundice of Non-malignant Origin
Lead Sponsor:
POLYSAN Scientific & Technological Pharmaceutical Company
Conditions:
Jaundice, Obstructive
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 j...
Detailed Description
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 s...
Eligibility Criteria
Inclusion
- 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 :
- hemoglobin ≥90 g / l;
- neutrophils ≥ 1.5x109 / l;
- Platelets ≥ 75 x 109 / L;
- AsAT and / or AlAT above 3 х normal but less than 20 х normal
- Serum creatinine not exceeding 2 × normal,
- Serum potassium within normal 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.
- Consent to abstain completely from alcohol intake during the study period.
Exclusion
- 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.
- 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.
- Any other decompensated disease.
- Pregnancy or lactation.
- Hypersensitivity to any component of the study drug / placebo and / or intolerance to any component of the study drug / placebo.
- Regular admission of medications prohibited or not permitted by the study protocol within 4 weeks prior to enrollment.
- Concomitant chronic systemic immune or hormonal therapy.
- Gout.
- Alcohol and/or drug dependence.
- Active tuberculosis, HIV infection, syphilis, acute viral hepatitis.
- Any other conditions / diseases that may interfere with the patient's compliance with the requirements of the Protocol.
- Mental, physical and other reasons that do not allow the patient to comply with the requirements of the study protocol.
- Any other significant (by judgement of the investigator) condition that prevents the patient from entering the study.
- Participation in any clinical trial in the previous 3 months.
- Staff of the research center and their family members.
Key Trial Info
Start Date :
April 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 13 2020
Estimated Enrollment :
342 Patients enrolled
Trial Details
Trial ID
NCT03418935
Start Date
April 3 2017
End Date
April 13 2020
Last Update
July 14 2020
Active Locations (13)
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1
Moscow 'City Clinical Hospital #24
Moscow, Russia
2
Moscow City Clinical Hospital #1 n.a.N.I.Pirogov
Moscow, Russia
3
Moscow City Clinical Hospital #29 n.a.N.A.Bauman
Moscow, Russia
4
Moscow City Clinical Hospital #67 n.a. L.A.Vorohobova
Moscow, Russia