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Remaxol® in Malignant Mechanical Jaundice

NCT03416062 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2020-07-10

No results posted yet for this study

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

Interventions

DRUG

Remaxol®

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

DRUG

Ringer's Solution

Solution for intravenous infusion, 400 or 800 ml

Sponsors & Collaborators

  • POLYSAN Scientific & Technological Pharmaceutical Company

    lead INDUSTRY

Principal Investigators

  • Mikhail S. Bogomolov, MD, PhD · St. Petersburg State Medical University n.a. I.P.Pavlov

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-03
Primary Completion
2020-02-03
Completion
2020-03-04

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03416062 on ClinicalTrials.gov