Status:
COMPLETED
Remaxol® in Malignant Mechanical Jaundice
Lead Sponsor:
POLYSAN Scientific & Technological Pharmaceutical Company
Conditions:
Jaundice; Malignant
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
The study will recruit in-hospital surgical patients with obstructive jaundice caused by malignancies of pancreatic and hepatobiliary zone. The study consists of the following periods: * Screening -...
Eligibility Criteria
Inclusion
- 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 :
- hemoglobin ≥90 g / l; neutrophils ≥ 1.5x109 / l; Platelets ≥ 75 x 109 / L; AsAT and / or AlAT above 3 х normal but less than 25 х normal Serum creatinine not exceeding 2 × normal, Serum potassium within normal limits
- Negative urine test for pregnancy in women of reproductive age.
- For reproductive age: consent to use adequate methods of contraception or for complete abstinence from sexual activity for the period of the study.
Exclusion
- 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).
- Liver cirrhosis
- 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.
- Regular intake of medications prohibited or not permitted by the study protocol within 4 weeks prior to enrollment or medical indication tio start any medication prohibited or not permitted by the study protocol
- 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 :
March 4 2020
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT03416062
Start Date
April 3 2017
End Date
March 4 2020
Last Update
July 10 2020
Active Locations (18)
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1
GBUZ 'Bryansk City Hospital #1'
Bryansk, Russia
2
Regional Clinical Hospital of Emergency Care n.a.M.A.Podgorbunsky
Kemerovo, Russia
3
KBUZ 'Regional Clinical Hospital'
Krasnoyarsk, Russia
4
OBUZ 'Kursy Regional Clinical Oncology Dispensary' of Kursky Regional Healthcare Department
Kursk, Russia