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Trial record 3 of 26 for:    Recruiting, Not yet recruiting, Available Studies | "Jaundice"

Remaxol® in Mechanical Jaundice of Non-malignant Origin

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ClinicalTrials.gov Identifier: NCT03418935
Recruitment Status : Recruiting
First Posted : February 1, 2018
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
POLYSAN Scientific & Technological Pharmaceutical Company

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.

Condition or disease Intervention/treatment Phase
Jaundice, Obstructive Drug: Remaxol (succinate + methionine + inosine + nicotinamide) Drug: Ringer's Solution Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 427 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 3, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: Remaxol®

Drug: Ringer's Solution
Intravenous infusion, 400 or 800 ml
Other Name: 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 Name: 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 Name: Placebo




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Serum bilirubin [ Time Frame: 14 days ]
    Dynamics of total and direct bilirubin serum levels against baseline values and between visits in the study groups

  5. 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

  6. 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

  7. Kidney function [ Time Frame: 14 days ]
    State of kidney function (serum creatinine) against baseline values and/or between visits

  8. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03418935


Contacts
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Contact: Aleksey L Kovalenko, Doc Biol Sci +78127108225 ext 212 science@polysan.ru

Locations
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Russian Federation
Moscow 'City Clinical Hospital #24 Recruiting
Moscow, Russian Federation
Contact: Grigory V. Rodoman         
Moscow City Clinical Hospital #1 n.a.N.I.Pirogov Recruiting
Moscow, Russian Federation
Contact: Kamil D. Dalgatov         
Moscow City Clinical Hospital #29 n.a.N.A.Bauman Recruiting
Moscow, Russian Federation
Contact: Maxim R. Kuznetsov         
Moscow City Clinical Hospital #67 n.a. L.A.Vorohobova Recruiting
Moscow, Russian Federation
Contact: Konstantin A. Pokrovsky         
Novosibirsk State Medical University Recruiting
Novosibirsk, Russian Federation
Contact: Lubov A. Shpagina         
City Clinical Hospital of Emergency Care Recruiting
Ryazan, Russian Federation
Contact: Alexandr A. Kopeikin         
North-West State Medical University named after I.I. Mechnikov Recruiting
Saint Petersburg, Russian Federation, 191015
Contact: Eldar E. Topuzov         
State Budgetary Health Care Institution "City Hospital № 26" Recruiting
Saint Petersburg, Russian Federation, 196247
Contact: Elena L. Belyaeva         
Hospital for War Veterans Recruiting
Saint Petersburg, Russian Federation
Contact: Georgy A. Belekhov         
Leningrad Regional Clinical Hospital Recruiting
Saint Petersburg, Russian Federation
Contact: Andrey S. Pryadko         
Saint-Petersburg I.I.Dzanelidze Research Institute of Emergency Medicine Recruiting
Saint Petersburg, Russian Federation
Contact: Anton S. Povzun         
City Clinical Hospital #3 n.a.B.I.Alperovich Recruiting
Tomsk, Russian Federation
Contact: Andrey P. Koshel         
GBUZ YO 'Regional Clinical Hospital' Recruiting
Yaroslavl, Russian Federation
Contact: Evgeny A. Volozhaev         
Sponsors and Collaborators
POLYSAN Scientific & Technological Pharmaceutical Company
Investigators
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Study Director: Mikhail S. Bogomolov, MD, PhD St. Petersburg State Medical University n.a. I.P.Pavlov.

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Responsible Party: POLYSAN Scientific & Technological Pharmaceutical Company
ClinicalTrials.gov Identifier: NCT03418935     History of Changes
Other Study ID Numbers: REM-OJ-III-16
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by POLYSAN Scientific & Technological Pharmaceutical Company:
obstructive jaundice, non-malignant
mechanical jaundice, non-malignant
Methionine
Succinic acid

Additional relevant MeSH terms:
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Jaundice
Jaundice, Obstructive
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Pharmaceutical Solutions
Niacinamide
Niacin
Nicotinic Acids
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents