Remaxol® in Mechanical Jaundice of Non-malignant Origin

NCT03418935 | Completed Phase 3

• 1 other identifier: REM-OJ-III-16
• Study Type: interventional
• Target: 342
• Locations: 1 country
• Sites: 13

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 jaundice of non-tumor cause during the first week after surgery.

Conditions

Jaundice, Obstructive

Keywords

obstructive jaundice, non-malignant; mechanical jaundice, non-malignant; Methionine; Succinic acid

Outcome Measures

Primary Outcomes (1)

• Days to regression of jaundice

  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 Outcomes (8)

• Disappearance of cytolysis (normal alanine aminotransferase and aspartate aminotransferase serum levels) on day 5

  5 days

• Disappearance of cholestasis on day 5

  5 days

• Disappearance of encephalopathy on day 5

  5 days

• Serum bilirubin

  14 days

• Serum enzymes

  14 days

Study Arms (3)

Remaxol 400 ml

EXPERIMENTAL

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); Drug: Ringer's Solution

Remaxol 800 ml

EXPERIMENTAL

Group II: treatment with Remaxol 800 ml IV for 7 days. Drug: Remaxol (succinate + methionine + inosine + nicotinamide)

Drug: Remaxol (succinate + methionine + inosine + nicotinamide)

Control

PLACEBO COMPARATOR

Group III: Ringer's solution 800 ml IV for 7 days. Drug: Ringer's solution

Drug: Ringer's Solution

Interventions

Remaxol (succinate + methionine + inosine + nicotinamide) DRUG

Solution for intravenous infusions, containing succinate, methionine, inosine, and nicotinamide in 400 ml glass bottle

Also known as: Remaxol®

Remaxol 400 ml; Remaxol 800 ml

Ringer's Solution DRUG

Intravenous infusion, 400 or 800 ml

Also known as: Placebo

Control; Remaxol 400 ml

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• POLYSAN Scientific & Technological Pharmaceutical Company: lead

Study Sites (13)

Moscow 'City Clinical Hospital #24

Moscow, Russia

Location

Moscow City Clinical Hospital #1 n.a.N.I.Pirogov

Moscow, Russia

Location

Moscow City Clinical Hospital #29 n.a.N.A.Bauman

Moscow, Russia

Location

Moscow City Clinical Hospital #67 n.a. L.A.Vorohobova

Moscow, Russia

Location

Novosibirsk State Medical University

Novosibirsk, Russia

Location

City Clinical Hospital of Emergency Care

Ryazan, Russia

Location

North-West State Medical University named after I.I. Mechnikov

Saint Petersburg, 191015, Russia

Location

State Budgetary Health Care Institution "City Hospital № 26"

Saint Petersburg, 196247, Russia

Location

Hospital for War Veterans

Saint Petersburg, Russia

Location

Leningrad Regional Clinical Hospital

Saint Petersburg, Russia

Location

Saint-Petersburg I.I.Dzanelidze Research Institute of Emergency Medicine

Saint Petersburg, Russia

Location

City Clinical Hospital #3 n.a.B.I.Alperovich

Tomsk, Russia

Location

GBUZ YO 'Regional Clinical Hospital'

Yaroslavl, Russia

Location

MeSH Terms

Conditions

Jaundice, Obstructive

Interventions

Remaxol; Succinic Acid; Methionine; Inosine; Niacinamide; Ringer's Solution

Condition Hierarchy (Ancestors)

Jaundice; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids, Sulfur; Sulfur Compounds; Amino Acids, Essential; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Neutral; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Nicotinic Acids; Acids, Heterocyclic; Pyridines; Heterocyclic Compounds, 1-Ring; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Mikhail S. Bogomolov, MD, PhD

  St. Petersburg State Medical University n.a. I.P.Pavlov.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: February 1, 2018
• Study Start: April 3, 2017
• Primary Completion: March 31, 2020
• Study Completion: April 13, 2020
• Last Updated: July 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (13)