Jaundice, ObstructivePhase 3NCT03418935
Remaxol® in Mechanical Jaundice of Non-malignant Origin
A Phase 3 study testing Remaxol (succinate + methionine + inosine + nicotinamide) and Ringer's Solution in people with Jaundice, Obstructive, run by POLYSAN Scientific & Technological Pharmaceutical Company at 13 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Jaundice, Obstructive
- What is being tested?
- Remaxol (succinate + methionine + inosine + nicotinamide) and Ringer's Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 342 participants
- Where
- 13 sitesRussia
- Study dates
- 3 Apr 2017to 13 Apr 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 :
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- 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.
Who cannot join
- 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.
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- 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.
- 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.
- Any other significant (by judgement of the investigator) condition that prevents the patient from entering the study.
- Participation in any clinical trial in the previous 3 months.
- Staff of the research center and their family members.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Russia13 sites
Moscow 'City Clinical Hospital #24
Moscow
Moscow City Clinical Hospital #1 n.a.N.I.Pirogov
Moscow
Moscow City Clinical Hospital #29 n.a.N.A.Bauman
Moscow
Moscow City Clinical Hospital #67 n.a. L.A.Vorohobova
Moscow
Novosibirsk State Medical University
Novosibirsk
City Clinical Hospital of Emergency Care
Ryazan
North-West State Medical University named after I.I. Mechnikov
Saint Petersburg, 191015
State Budgetary Health Care Institution "City Hospital № 26"
Saint Petersburg, 196247
Hospital for War Veterans
Saint Petersburg
Leningrad Regional Clinical Hospital
Saint Petersburg
Saint-Petersburg I.I.Dzanelidze Research Institute of Emergency Medicine
Saint Petersburg
City Clinical Hospital #3 n.a.B.I.Alperovich
Tomsk
GBUZ YO 'Regional Clinical Hospital'
Yaroslavl
About this study
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
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.
Read the 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.
- Conditions
- Jaundice, Obstructive
- Being tested
- Remaxol (succinate + methionine + inosine + nicotinamide), Ringer's Solution
- Keywords
- obstructive jaundice, non-malignant, mechanical jaundice, non-malignant, Methionine, Succinic acid
- Medical subject headings
- Jaundice, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remaxol (succinate + methionine + inosine + nicotinamide)Drug
Also called Remaxol®
Solution for intravenous infusions, containing succinate, methionine, inosine, and nicotinamide in 400 ml glass bottle
Ringer's SolutionDrug
Also called Placebo
Intravenous infusion, 400 or 800 ml
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Drug: Remaxol (succinate + methionine + inosine + nicotinamide) |
| Control | Placebo comparator | Group III: Ringer's solution 800 ml IV for 7 days. Drug: Ringer's solution Receives: Drug: Ringer's Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 days
Secondary outcomes (8)
Disappearance of cytolysis (normal alanine aminotransferase and aspartate aminotransferase serum levels) on day 5
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
Measured: 5 days
Disappearance of cholestasis on day 5
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
Measured: 5 days
Disappearance of encephalopathy on day 5
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
Measured: 5 days
Serum bilirubin
Dynamics of total and direct bilirubin serum levels against baseline values and between visits in the study groups
Measured: 14 days
Serum enzymes
Dynamics of serum alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and GGTP against baseline values and between visits in the study groups
Measured: 14 days
Liver function
State of liver protein synthesis function (as reflected by serum levels of total protein, albumin, fibrinogen) against baseline values and/or between visits
Measured: 14 days
Kidney function
State of kidney function (serum creatinine) against baseline values and/or between visits
Measured: 14 days
Proportion of patients with complications of jaundice
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).
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start3 Apr 2017
- Primary completion31 Mar 2020
- Study completion13 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jaundice, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- POLYSAN Scientific & Technological Pharmaceutical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mikhail S. Bogomolov, MD, PhD, Study director, St. Petersburg State Medical University n.a. I.P.Pavlov.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03418935
- Sponsor's protocol ID
- REM-OJ-III-16
- Status last verified
- Jul 2020
- First submitted
- 19 Jan 2018
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03418935
- Acronym / sponsor ID
- REM-OJ-III-16
- Conditions
- Jaundice, Obstructive
- Keywords
- obstructive jaundice, non-malignant, mechanical jaundice, non-malignant, Methionine, Succinic acid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- POLYSAN Scientific & Technological Pharmaceutical CompanyIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 13 Apr 2020 (actual)
- First posted
- 1 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Remaxol 400 ml | Experimental | Drug: Remaxol (succinate + methionine + inosine + nicotinamide), Drug: Ringer's SolutionGroup I: treatment with Remaxol 400 ml IV + Ringer solution 400 ml IV for 7 days. Drug: Remaxol (succinate + methionine + inosine + nicotinamide) |
| Remaxol 800 ml | Experimental | Drug: Remaxol (succinate + methionine + inosine + nicotinamide)Group II: treatment with Remaxol 800 ml IV for 7 days. Drug: Remaxol (succinate + methionine + inosine + nicotinamide) |
| Control | Placebo comparator | Drug: Ringer's SolutionGroup III: Ringer's solution 800 ml IV for 7 days. Drug: Ringer's solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remaxol (succinate + methionine + inosine + nicotinamide)Also: Remaxol®Solution for intravenous infusions, containing succinate, methionine, inosine, and nicotinamide in 400 ml glass bottle | Drug | Remaxol 400 ml, Remaxol 800 ml |
| Ringer's SolutionAlso: PlaceboIntravenous infusion, 400 or 800 ml | Drug | Control, Remaxol 400 ml |
Primary outcome
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
8 secondary outcomes
Disappearance of cytolysis (normal alanine aminotransferase and aspartate aminotransferase serum levels) on day 5
Time frame: 5 days
Disappearance of cholestasis on day 5
Time frame: 5 days
Disappearance of encephalopathy on day 5
Time frame: 5 days
Serum bilirubin
Time frame: 14 days
Serum enzymes
Time frame: 14 days
Liver function
Time frame: 14 days
Kidney function
Time frame: 14 days
Proportion of patients with complications of jaundice
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikhail S. Bogomolov, MD, PhD study director
St. Petersburg State Medical University n.a. I.P.Pavlov.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Remaxol (succinate + methionine + inosine + nicotinamide) and Ringer's Solution in people with Jaundice, Obstructive, run by POLYSAN Scientific & Technological Pharmaceutical Company at 13 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days to regression of jaundice (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.