- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03416062
Remaxol® in Malignant Mechanical Jaundice
A Multicenter, Double-blind, Placebo-controlled, Randomized Trial of the Efficacy and Safety of Remaxol®, a Solution for Infusions Produced by STPF POLYSAN (Russia), in Patients With Malignant Mechanical Jaundice
Study Overview
Status
Conditions
Intervention / Treatment
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 - preliminary examination of patients (duration up to 3 days).
- Period of therapy (including surgery and postoperative period) - treatment with the investigational product Remaxol®, solution for infusions, (NTFF POLYSAN Ltd., Russia) or placebo, as part of standard infusion therapy during the postoperative period of patients with mechanical jaundice of malignant origin (duration 10 days).
- The period of follow-up (duration - 3 weeks after the end of treatment).
After the screening, patients who meet the inclusion criteria and do not have exclusion criteria will be randomly assigned to three groups (1:1:1):
- Group I: treatment with Remaxol® 400 ml IV, and placebo (Ringer solution) 400 ml IV, once a day for 10 days, along with standard infusion therapy.
- Group II: treatment Remaxol® 800 ml IV, once a day for 10 days, along with standard infusion therapy.
- Group III: patients will receive placebo ((Ringer solution) 800 ml IV, once a day for 10 days, along with standard infusion therapy.
Assessment will include physical examination data, vital signs, blood tests (CBC, biochemistry - protein, albumin, AST, ALT, APG, GGTP, LDH, total bilirubin, direct bilirubin, amylase, glucose, electrolytes, creatinine, urea, uric acid, C -reactive protein, lipid profile; coagulogram; urine samples), ECOG assessment, repeated abdominal ultrasound, neurophysiological test for the evaluation of encephalopathy, record of bile volume by drainage (if applicable).
All patients will be followed up for 31 days.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Bryansk, Russian Federation
- GBUZ 'Bryansk City Hospital #1'
-
Kemerovo, Russian Federation
- Regional Clinical Hospital of Emergency Care n.a.M.A.Podgorbunsky
-
Krasnoyarsk, Russian Federation
- KBUZ 'Regional Clinical Hospital'
-
Kursk, Russian Federation
- OBUZ 'Kursy Regional Clinical Oncology Dispensary' of Kursky Regional Healthcare Department
-
Moscow, Russian Federation
- Moscow City Clinical Hospital #1 n.a.N.I.Pirogov
-
Moscow, Russian Federation
- Moscow City Clinical Hospital #29 n.a.N.A.Bauman
-
Omsk, Russian Federation
- Omsk Regional Clinical Oncology Center
-
Penza, Russian Federation
- GBUZ "Penza Regional Clinical Hospital na N.N.Burdenko"
-
Ryazan, Russian Federation
- City Clinical Hospital of Emergency Care
-
Saint Petersburg, Russian Federation
- Hospital for War Veterans
-
Saint Petersburg, Russian Federation
- Saint-Petersburg I.I.Dzanelidze Research Institute of Emergency Medicine
-
Saint Petersburg, Russian Federation
- GBUZ 'Leningrad Regional Oncology Center'
-
Saint Petersburg, Russian Federation
- GBUZ Leningrad Regional Clinical Hospital
-
Saint Petersburg, Russian Federation
- North-West State Medical University named after I.I. Mechnikov
-
Saint Petersburg, Russian Federation
- SPb GBUZ "City Hospital №26"
-
Saint Petersburg, Russian Federation
- SPb GBUZ 'City Mariinskaya Hospital'
-
Tomsk, Russian Federation
- Siberian State Medical University
-
Tomsk, Russian Federation
- OGAUZ "Tomsk Regional Clinical Hospital"
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 :
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 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).
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Remaxol® 400 ml + Placebo 400 ml
Treatment with Remaxol® 400 ml IV + Ringer solution 400 ml IV for 10 days.
Drug: Remaxol (succinate + methionine + inosine + nicotinamide)
|
Solution for intravenous infusions, containing succinate, methionine, inosine, and nicotinamide in 400 ml glass bottle
Other Names:
Solution for intravenous infusion, 400 or 800 ml
Other Names:
|
Experimental: Remaxol® 800 ml
Treatment with Remaxol® 800 ml IV for 10 days.
Drug: Remaxol (succinate + methionine + inosine + nicotinamide)
|
Solution for intravenous infusions, containing succinate, methionine, inosine, and nicotinamide in 400 ml glass bottle
Other Names:
|
Placebo Comparator: Control
Treatment with Ringer's solution 800 ml IV for 7 days.
Drug: Ringer's solution
|
Solution for intravenous infusion, 400 or 800 ml
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to regression of jaundice
Time Frame: 21 days
|
The time (days) from the day of the drainage operation to the reduction of the total bilirubin level down to 90 μmol / l, in experimental (Remaxol®) vs. control (Placebo) groups
|
21 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Regression of cytolysis (normal alanine aminotransferase and aspartate aminotransferase serum levels)
Time Frame: 11 days
|
Proportion of patients in study groups who reached normal serum levels of alanine aminotransferase and aspartate aminotransferase on day 11 from the start of treatment
|
11 days
|
Regression of cholestasis
Time Frame: 11 days
|
Proportion of patients in study groups who reached normal serum levels of alkaline phosphatase, GGTP, total bilirubin, and direct bilirubin on day 11 from the start of treatment
|
11 days
|
Regression of encephalopathy
Time Frame: 11 days
|
Proportion of patients in study groups who had normal brain functioning on day 11, as reflected by the neurophysiological test for the evaluation of the degree of encephalopathy
|
11 days
|
Serum bilirubin
Time Frame: 21 days
|
Dynamics of total and direct bilirubin serum levels against baseline values and between visits in the study groups
|
21 days
|
Serum alkaline phosphatase
Time Frame: 21 days
|
Dynamics of serum alkaline phosphatase level against baseline values and between visits in the study groups
|
21 days
|
Serum GGTP
Time Frame: 21 days
|
Dynamics of serum gamma-glutamyltranspeptidase level against baseline values and between visits in the study groups
|
21 days
|
Serum alanine aminotransferase
Time Frame: 21 days
|
Dynamics of serum alanine aminotransferase level against baseline values and between visits in the study groups
|
21 days
|
Serum aspartate aminotransferase
Time Frame: 21 days
|
Dynamics of serum aspartate aminotransferase level against baseline values and between visits in the study groups
|
21 days
|
Liver function
Time Frame: 21 days
|
State of liver protein synthesis function (as reflected by serum levels of total protein, albumin, INR, PT, PTI, APTT, fibrinogen) against baseline values and/or between visits
|
21 days
|
Kidney function
Time Frame: 21 days
|
State of kidney function (creatinine serum level) against baseline values and/or between visits
|
21 days
|
Proportion of patients with complications of jaundice
Time Frame: 21 days
|
The number of patients in the study groups who developed complications in the postoperative period which were, according to the researcher's assessment, causally related to the obstructive jaundice (for example, purulent cholangitis, sepsis, kidney failure)
|
21 days
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Time Frame: 31 days
|
Status of patients in the study groups by ECOG (Eastern Cooperative Oncology Group) grades at the end of the study. ECOG Performance Status consists of the following grades: 0 - fully active, able to carry on all pre-disease performance without restriction;
|
31 days
|
Collaborators and Investigators
Investigators
- Study Director: Mikhail S. Bogomolov, MD, PhD, St. Petersburg State Medical University n.a. I.P.Pavlov
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REM-CJ-III-16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Jaundice; Malignant
-
Emergency County Hospital Pius Brinzeu; Timisoara...Department of Gastroenterology, Clinical Emergency Hospital of Bucharest,... and other collaboratorsRecruitingBiliary Tract Diseases | Choledocholithiasis | Jaundice, Obstructive | Cholangitis Acute | Jaundice; MalignantRomania
-
Azienda Unità Sanitaria Locale della RomagnaRecruitingCholedocholithiasis | Biliary Disease | Biliary Stricture | Jaundice, Obstructive | Jaundice; MalignantItaly
-
Azienda Unità Sanitaria Locale della RomagnaCompletedCommon Bile Duct Stricture | Jaundice; MalignantItaly
-
Xian-Jun YuRecruitingThe Influence of Antibiotics on the Incidence of Biliary Tract Infections After PTCD for Malignant Obstructive JaundiceChina
-
Shree Birendra HospitalBP Koirala Institute of Health SciencesCompletedObstuctive Jaundice | Radiological Correlation of Obstructive JaundiceNepal
-
Jiaolin Ning,MDUnknown
-
zhaoyu liuUnknown
-
Sohag UniversityRecruitingCalcular Obstructive JaundiceEgypt
-
Turkish Ministry of Health Izmir Teaching HospitalCompleted
-
Huazhong University of Science and TechnologyCompletedSurgical Procedure, Unspecified | Obstructive JaundiceChina
Clinical Trials on Remaxol®
-
POLYSAN Scientific & Technological Pharmaceutical...RecruitingCancer | Drug Induced Liver InjuryRussian Federation
-
POLYSAN Scientific & Technological Pharmaceutical...Completed
-
POLYSAN Scientific & Technological Pharmaceutical...RecruitingObstructive Jaundice | Gallstone DiseaseRussian Federation
-
Dong-A ST Co., Ltd.CompletedFunctional DyspepsiaKorea, Republic of
-
Chong Kun Dang PharmaceuticalCompleted
-
POLYSAN Scientific & Technological Pharmaceutical...RecruitingCholestasis, IntrahepaticRussian Federation
-
Galderma R&DCompletedAtopic DermatitisPhilippines, China
-
Sanofi Pasteur, a Sanofi CompanyCompletedPertussis | Diphtheria | PolioUnited States
-
Chung-Ang University Hosptial, Chung-Ang University...UnknownFunctional DyspepsiaKorea, Republic of