Remaxol® in Malignant Mechanical Jaundice

NCT03416062 | Completed Phase 3

• 1 other identifier: REM-CJ-III-16
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 18

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 patients with obstructive jaundice caused by tumor (malignancy).

Conditions

Jaundice; Malignant

Keywords

Jaundice, obstructive; Methionine; Succinic acid

Outcome Measures

Primary Outcomes (1)

• Time to regression of jaundice

  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 Outcomes (12)

• Regression of cytolysis (normal alanine aminotransferase and aspartate aminotransferase serum levels)

  11 days

• Regression of cholestasis

  11 days

• Regression of encephalopathy

  11 days

• Serum bilirubin

  21 days

• Serum alkaline phosphatase

  21 days

Study Arms (3)

Remaxol® 400 ml + Placebo 400 ml

EXPERIMENTAL

Treatment with Remaxol® 400 ml IV + Ringer solution 400 ml IV for 10 days. Drug: Remaxol (succinate + methionine + inosine + nicotinamide)

Drug: Remaxol®; Drug: Ringer's Solution

Remaxol® 800 ml

EXPERIMENTAL

Treatment with Remaxol® 800 ml IV for 10 days. Drug: Remaxol (succinate + methionine + inosine + nicotinamide)

Drug: Remaxol®

Control

PLACEBO COMPARATOR

Treatment with Ringer's solution 800 ml IV for 7 days. Drug: Ringer's solution

Drug: Ringer's Solution

Interventions

Remaxol® DRUG

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

Also known as: Remaxol (succinate + methionine + inosine + nicotinamide)

Remaxol® 400 ml + Placebo 400 ml; Remaxol® 800 ml

Ringer's Solution DRUG

Solution for intravenous infusion, 400 or 800 ml

Also known as: Placebo

Control; Remaxol® 400 ml + Placebo 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• POLYSAN Scientific & Technological Pharmaceutical Company: lead

Study Sites (18)

GBUZ 'Bryansk City Hospital #1'

Bryansk, Russia

Location

Regional Clinical Hospital of Emergency Care n.a.M.A.Podgorbunsky

Kemerovo, Russia

Location

KBUZ 'Regional Clinical Hospital'

Krasnoyarsk, Russia

Location

OBUZ 'Kursy Regional Clinical Oncology Dispensary' of Kursky Regional Healthcare Department

Kursk, 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

Omsk Regional Clinical Oncology Center

Omsk, Russia

Location

GBUZ "Penza Regional Clinical Hospital na N.N.Burdenko"

Penza, Russia

Location

City Clinical Hospital of Emergency Care

Ryazan, Russia

Location

GBUZ 'Leningrad Regional Oncology Center'

Saint Petersburg, Russia

Location

GBUZ Leningrad Regional Clinical Hospital

Saint Petersburg, Russia

Location

Hospital for War Veterans

Saint Petersburg, Russia

Location

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

Saint Petersburg, Russia

Location

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

Saint Petersburg, Russia

Location

SPb GBUZ "City Hospital №26"

Saint Petersburg, Russia

Location

SPb GBUZ 'City Mariinskaya Hospital'

Saint Petersburg, Russia

Location

OGAUZ "Tomsk Regional Clinical Hospital"

Tomsk, Russia

Location

Siberian State Medical University

Tomsk, Russia

Location

MeSH Terms

Conditions

Jaundice; Jaundice, Obstructive

Interventions

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

Condition Hierarchy (Ancestors)

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 23, 2018
• First Posted: January 30, 2018
• Study Start: April 3, 2017
• Primary Completion: February 3, 2020
• Study Completion: March 4, 2020
• Last Updated: July 10, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (18)