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Remaxol® in Mechanical Jaundice of Non-malignant Origin

NCT03418935 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 342

Last updated 2020-07-14

No results posted yet for this study

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

Interventions

DRUG

Remaxol (succinate + methionine + inosine + nicotinamide)

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

DRUG

Ringer's Solution

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
2020-03-31
Completion
2020-04-13

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 NCT03418935 on ClinicalTrials.gov