Remaxol® in Mechanical Jaundice of Non-malignant Origin

July 10, 2020 updated by: POLYSAN Scientific & Technological Pharmaceutical Company

A Multicenter, Double-Blind, Placebo-Controlled, Randomized Trial of Efficacy and Safety of Remaxol®, a Solution for Intravenous Infusions Produced by STPF "POLYSAN" (Russia), in Patients With Mechanical Jaundice of Non-Malignant Origin

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 screened in the 15 days preceeding the appointed drainage surgery. The treatment will be started in the first 6 hours after the drainage surgery and continue for 7 days.

Following screening, patients who meet the inclusion criteria and have no criteria for exclusion will be randomly assigned into three study groups in the proportion of 1: 1: 1):

Group I: treatment with Remaxol 400 ml IV + Ringer solution 400 ml IV for 7 days.

Group II: treatment with Remaxol 800 ml IV for 7 days. Group III (control): Ringer solution 800 ml IV for 7 days.

Physical examination data, vital signs, biochemistry panel (including bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, GGTP) will be assessed on days 1-8, on day 11 and day 14.

Diagnostic abdominal ultrasound will be performed before surgery and on days 3 and 8.

Neurophysiological test for the evaluation of the degree of encephalopathy will be performed before surgery, on days 3, 5, 8, and 14.

All patients will be followed up for 14 days.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
342

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • 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
      • Moscow, Russian Federation
        • Moscow 'City Clinical Hospital #24
      • Moscow, Russian Federation
        • Moscow City Clinical Hospital #67 n.a. L.A.Vorohobova
      • Novosibirsk, Russian Federation
        • Novosibirsk State Medical University
      • 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, 191015
        • North-West State Medical University named after I.I. Mechnikov
      • Saint Petersburg, Russian Federation, 196247
        • State Budgetary Health Care Institution "City Hospital № 26"
      • Saint Petersburg, Russian Federation
        • Leningrad Regional Clinical Hospital
      • Tomsk, Russian Federation
        • City Clinical Hospital #3 n.a.B.I.Alperovich
      • Yaroslavl, Russian Federation
        • GBUZ YO 'Regional Clinical Hospital'

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Presence of signed informed consent for participation in the study.
  2. Men and women over the age of 18 (incl.).
  3. Obstructive jaundice, verified by enlargement of intrahepatic bile ducts with proven non-tumor obstruction of extrahepatic bile ducts.
  4. Duration of mechanical jaundice 15 days or less.
  5. The level of total bilirubin in the blood from 5-fold to 20-fold exceeding normal.

  6. 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
  7. Negative urine test for pregnancy in women of reproductive age.
  8. Consent to use adequate methods of contraception or for complete abstinence from sexual activity for the period of the study.
  9. Consent to abstain completely from alcohol intake during the study period.

Exclusion Criteria:

  1. Tumor causing the obstruction of the bile ducts or the presence of any other malignancy at the time of randomization.
  2. The need for another radical surgery within 2 weeks from the planned date of randomization.
  3. Acute destructive pancreatitis, diffuse or diffuse peritonitis, sepsis.
  4. Preexisting liver cirrhosis.
  5. Exacerbation of the chronic peptic ulcer.
  6. Ongoing bleeding.
  7. 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.
  8. Any other decompensated disease.
  9. Pregnancy or lactation.
  10. Hypersensitivity to any component of the study drug / placebo and / or intolerance to any component of the study drug / placebo.
  11. Regular admission of medications prohibited or not permitted by the study protocol within 4 weeks prior to enrollment.
  12. Concomitant chronic systemic immune or hormonal therapy.
  13. Gout.
  14. Alcohol and/or drug dependence.
  15. Active tuberculosis, HIV infection, syphilis, acute viral hepatitis.
  16. Any other conditions / diseases that may interfere with the patient's compliance with the requirements of the Protocol.
  17. Mental, physical and other reasons that do not allow the patient to comply with the requirements of the study protocol.
  18. Any other significant (by judgement of the investigator) condition that prevents the patient from entering the study.
  19. Participation in any clinical trial in the previous 3 months.
  20. Staff of the research center and their family members.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Remaxol 400 ml
Group I: treatment with Remaxol 400 ml IV + Ringer solution 400 ml IV for 7 days. Drug: Remaxol (succinate + methionine + inosine + nicotinamide)
Drug: Remaxol (succinate + methionine + inosine + nicotinamide)
Solution for intravenous infusions, containing succinate, methionine, inosine, and nicotinamide in 400 ml glass bottle
Other Names:
  • Remaxol®
Drug: Ringer's Solution
Intravenous infusion, 400 or 800 ml
Other Names:
  • Placebo
Experimental: Remaxol 800 ml
Group II: treatment with Remaxol 800 ml IV for 7 days. Drug: Remaxol (succinate + methionine + inosine + nicotinamide)
Drug: Remaxol (succinate + methionine + inosine + nicotinamide)
Solution for intravenous infusions, containing succinate, methionine, inosine, and nicotinamide in 400 ml glass bottle
Other Names:
  • Remaxol®
Placebo Comparator: Control
Group III: Ringer's solution 800 ml IV for 7 days. Drug: Ringer's solution
Drug: Ringer's Solution
Intravenous infusion, 400 or 800 ml
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Days to regression of jaundice
Time Frame: 14 days
Time (days) from the date of drainage surgery to the reduction of the total bilirubin level down to 50 μmol / l, in experimental (Remaxol®) and control (Placebo) groups
14 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Disappearance of cytolysis (normal alanine aminotransferase and aspartate aminotransferase serum levels) on day 5
Time Frame: 5 days
Proportion of patients in study groups who reached normal serum levels of alanine aminotransferase and aspartate aminotransferase on day 5 from the start of treatment
5 days
Disappearance of cholestasis on day 5
Time Frame: 5 days
Proportion of patients in study groups who reached normal serum levels of alkaline phosphatase, GGTP, total bilirubin, and direct bilirubin on day 5 from the start of treatment
5 days
Disappearance of encephalopathy on day 5
Time Frame: 5 days
Proportion of patients in study groups who had normal brain functioning on day 5, as reflected by the neurophysiological test for the evaluation of the degree of encephalopathy
5 days
Serum bilirubin
Time Frame: 14 days
Dynamics of total and direct bilirubin serum levels against baseline values and between visits in the study groups
14 days
Serum enzymes
Time Frame: 14 days
Dynamics of serum alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and GGTP against baseline values and between visits in the study groups
14 days
Liver function
Time Frame: 14 days
State of liver protein synthesis function (as reflected by serum levels of total protein, albumin, fibrinogen) against baseline values and/or between visits
14 days
Kidney function
Time Frame: 14 days
State of kidney function (serum creatinine) against baseline values and/or between visits
14 days
Proportion of patients with complications of jaundice
Time Frame: 14 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).
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
POLYSAN Scientific & Technological Pharmaceutical Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mikhail S. Bogomolov, MD, PhD, St. Petersburg State Medical University n.a. I.P.Pavlov.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 3, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 13, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 1, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REM-OJ-III-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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