Gallstone DiseaseNCT05928286
Remaxol® Used in the Treatment of Patients With Gallstone Disease Complicated With Obstructive Jaundice
An observational study of Gallstone Disease and Obstructive Jaundice, run by POLYSAN Scientific & Technological Pharmaceutical Company at 9 sites in Russia.
Trial summary
Obstructive jaundice is observed in 10-80 % of gallstone disease cases. The conventional tactics for the management of patients with obstructive jaundice is to remove biliary hypertension by using endoscopic or minimally invasive methods. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gallstone Disease, Obstructive Jaundice
- What is being tested?
- Remaxol
- Type of treatment
- Injection or infusion
- How many people
- 286 participants
- Where
- 9 sitesRussia
- Study dates
- 1 Dec 2022to 31 Dec 2025
- Phase
- Observational
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with gallstone disease and obstructive jaundice, hospitalized for surgical treatment.
Who may be able to join
- Signed informed consent form.
- Age from 18 to 80 years
- Diagnosis: Gallstone disease. Cholelithiasis, choledocholithiasis. Obstructive jaundice.
- Total bilirubin level in the blood in the range from 60 to 246 µmol/l.
- Jaundice duration according to the patient is not more than 7 days.
- Scheduled two-staged surgical treatment: 1) common bile duct decompression (endoscopic papillosphincterotomy and endoscopic lithoextraction); 2) laparoscopic cholecystectomy.
Who cannot join
- Presence of other pathology causing jaundice syndrome (tumors, constrictions, etc.).
- Acute cholangitis. Acute cholecystitis. Acute pancreatitis.
- History of chronic viral hepatitis, hepatic cirrhosis.
- Other surgical pathology aggravating the condition and/or requiring treatment.
- Use in the treatment of drugs containing ademethionine.
- CHF, functional class III-IV according to NYHA.
Show all 14Show fewer
- History of chronic kidney disease and/or creatinine level of more than 130 µmol/l.
- Respiratory failure.
- Impairment of consciousness.
- Diabetes mellitus.
- Psychic diseases.
- Autoimmune diseases.
- Tuberculosis, HIV infection.
- Pregnancy, lactation.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Russia9 sites
Krai Clinical Hospital
Barnaul
Hospital for War Veterans
Kazan'
City Clinical Hospital No. 7
Nizhny Novgorod
Pavlov Ryazan State Medical University
Ryazan
Dzhanelidze St. Petersburg Research Institute of Emergency Medicine
Saint Petersburg
St. Elizabeth Hospital
Saint Petersburg
Samara State Medical University
Samara
Mirotvortsev University Clinical Hospital No. 1
Saratov
Kuvatov Republican Clinical Hospital
Ufa
About this study
Official title: Observational Study of Efficiency of the Drug Remaxol® (Inosine + Meglumine + Methionine + Nicotinamide + Succinic Acid) Used in the Treatment of Patients With Gallstone Disease Complicated With Obstructive Jaundice
Obstructive jaundice is observed in 10-80 % of gallstone disease cases. The conventional tactics for the management of patients with obstructive jaundice is to remove biliary hypertension by using endoscopic or minimally invasive methods. The final surgical treatment is performed after jaundice reduction and normalization of hepatic functions. We suppose that the administration of the drug Remaxol (Inosine + Meglumine + Methionine + Nicotinamide + Succinic acid) during the perioperative period shortens jaundice duration and decreases the complications rate.
- Conditions
- Gallstone Disease, Obstructive Jaundice
- Being tested
- Remaxol
- Keywords
- Gallstone disease, Obstructive jaundice, Remaxol
- Medical subject headings
- Cholelithiasis, Jaundice, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemaxolDrug
The perioperative infusion of Remaxol® (Inosine + Meglumine + Methionine + Nicotinamide + Succinic acid)
| Study group | Role | What they receive |
|---|---|---|
| The test group | Standard therapy + Remaxol Receives: Drug: Remaxol | |
| The control group | Standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapy response rate: decrease of total bilirubin level down to 20.5 µmol/l Visit 3 or decrease in total bilirubin by 70% compared to Visit 1.
Decrease of total bilirubin level down to 20.5 µmol/l Visit 3 or decrease in total bilirubin by 70% compared to Visit 1.
Measured: Up to 2 weeks
Secondary outcomes (14)
Therapy response rate: decrease of total bilirubin level down to 61.5 µmol/l and lower by the time of cholecystectomy
Decrease of total bilirubin level down to 61.5 µmol/l and lower by the time of cholecystectomy, after successful common bile duct decompression.
Measured: Up to 2 weeks
Complication rate in the postoperative period
Acute pancreatitis, acute renal failure, acute heart failure, pneumonia, stress hyperglycemia, infectious complications
Measured: Up to 2 weeks
Total hospitalization duration in days (in case of two-staged surgical treatment).
Total hospitalization duration in days
Measured: Up to 2 weeks
Total hyperbilirubinemia duration (in days) after the beginning of fluid administration.
Total hyperbilirubinemia duration (in days) after the beginning of fluid administration
Measured: Up to 2 weeks
Interval (in days) between surgical interventions
Interval (in days) between surgical interventions
Measured: Up to 2 weeks
Change of hepatic function tests (AST,)
Change of hepatic function tests (AST) relative to baseline values, on the day after common bile duct decompression, by the time of cholecystectomy, on the day after cholecystectomy, and on the day of hospitalization termination.
Measured: Baseline, on the day after surgery, up to 2 weeks
Change of hepatic function tests ( ALT)
Change of hepatic function tests (ALT) relative to baseline values, on the day after common bile duct decompression, by the time of cholecystectomy, on the day after cholecystectomy, and on the day of hospitalization termination.
Measured: Baseline, on the day after surgery, up to 2 weeks
Change of hepatic function test ( AP)
Change of hepatic function test ( AP) relative to baseline values, on the day after common bile duct decompression, by the time of cholecystectomy, on the day after cholecystectomy, and on the day of hospitalization termination.
Measured: Baseline, on the day after surgery, up to 2 weeks
Change of hepatic function test (GGTP)
Change of hepatic function test (GGTP) relative to baseline values, on the day after common bile duct decompression, by the time of cholecystectomy, on the day after cholecystectomy, and on the day of hospitalization termination.
Measured: Baseline, on the day after surgery, up to 2 weeks
Change of hepatic function tests (protein, albumin, fibrinogen)
Change of hepatic function tests (protein, albumin, fibrinogen) relative to baseline values, on the day after common bile duct decompression, by the time of cholecystectomy, on the day after cholecystectomy, and on the day of hospitalization termination.
Measured: Baseline, on the day after surgery, up to 2 weeks
Change of PTI
Change of PTI relative to baseline values, on the day after common bile duct decompression, by the time of cholecystectomy, on the day after cholecystectomy, and on the day of hospitalization termination.
Measured: Baseline, on the day after surgery, up to 2 weeks
Change of renal function test (urea)
Change of renal function test (urea) relative to baseline values, on the day after common bile duct decompression, by the time of cholecystectomy, on the day after cholecystectomy, and on the day of hospitalization termination.
Measured: Baseline, on the day after surgery, up to 2 weeks
Change of renal function test (creatinine)
Change of renal function test (creatinine) relative to baseline values, on the day after common bile duct decompression, by the time of cholecystectomy, on the day after cholecystectomy, and on the day of hospitalization termination.
Measured: Baseline, on the day after surgery, up to 2 weeks
Number of patients whose cholecystectomy was delayed till next hospitalization because of the insufficient dynamics of decrease in bilirubinemia.
Number of patients whose cholecystectomy was delayed till next hospitalization because of the insufficient dynamics of decrease in bilirubinemia.
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Dec 2022
- Primary completion1 Sep 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallstone DiseaseStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- POLYSAN Scientific & Technological Pharmaceutical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928286
- Sponsor's protocol ID
- Remaxol\2022\02
- Status last verified
- Apr 2026
- First submitted
- 28 Dec 2022
- Last updated
- 21 Apr 2026
- 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 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Efficiency of the Drug Remaxol® (Inosine + Meglumine + Methionine + Nicotinamide + Succinic Acid) Used in the Treatment of Patients With Gallstone Disease Complicated With Obstructive Jaundice
- ClinicalTrials.gov ID
- NCT05928286
- Acronym / sponsor ID
- Remaxol\2022\02
- Conditions
- Gallstone Disease, Obstructive Jaundice
- Keywords
- Gallstone disease, Obstructive jaundice, Remaxol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- POLYSAN Scientific & Technological Pharmaceutical CompanyIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 3 Jul 2023 (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.
Obstructive jaundice is observed in 10-80 % of gallstone disease cases. The conventional tactics for the management of patients with obstructive jaundice is to remove biliary hypertension by using endoscopic or minimally invasive methods. The final surgical treatment is performed after jaundice reduction and normalization of hepatic functions. We suppose that the administration of the drug Remaxol (Inosine + Meglumine + Methionine + Nicotinamide + Succinic acid) during the perioperative period shortens jaundice duration and decreases the complications rate.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The test group | – | Drug: RemaxolStandard therapy + Remaxol |
| The control group | – | –Standard therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with gallstone disease and obstructive jaundice, hospitalized for surgical treatment.
Key inclusion criteria (6 listed)
- Signed informed consent form.
- Age from 18 to 80 years
- Diagnosis: Gallstone disease. Cholelithiasis, choledocholithiasis. Obstructive jaundice.
- Total bilirubin level in the blood in the range from 60 to 246 µmol/l.
- Jaundice duration according to the patient is not more than 7 days.
Key exclusion criteria (14 listed)
- Presence of other pathology causing jaundice syndrome (tumors, constrictions, etc.).
- Acute cholangitis. Acute cholecystitis. Acute pancreatitis.
- History of chronic viral hepatitis, hepatic cirrhosis.
- Other surgical pathology aggravating the condition and/or requiring treatment.
- Use in the treatment of drugs containing ademethionine.
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 |
|---|---|---|
| RemaxolThe perioperative infusion of Remaxol® (Inosine + Meglumine + Methionine + Nicotinamide + Succinic acid) | Drug | The test group |
Primary outcome
Therapy response rate: decrease of total bilirubin level down to 20.5 µmol/l Visit 3 or decrease in total bilirubin by 70% compared to Visit 1.
Time frame: Up to 2 weeks
Decrease of total bilirubin level down to 20.5 µmol/l Visit 3 or decrease in total bilirubin by 70% compared to Visit 1.
14 secondary outcomes
Therapy response rate: decrease of total bilirubin level down to 61.5 µmol/l and lower by the time of cholecystectomy
Time frame: Up to 2 weeks
Complication rate in the postoperative period
Time frame: Up to 2 weeks
Total hospitalization duration in days (in case of two-staged surgical treatment).
Time frame: Up to 2 weeks
Total hyperbilirubinemia duration (in days) after the beginning of fluid administration.
Time frame: Up to 2 weeks
Interval (in days) between surgical interventions
Time frame: Up to 2 weeks
Change of hepatic function tests (AST,)
Time frame: Baseline, on the day after surgery, up to 2 weeks
Change of hepatic function tests ( ALT)
Time frame: Baseline, on the day after surgery, up to 2 weeks
Change of hepatic function test ( AP)
Time frame: Baseline, on the day after surgery, up to 2 weeks
Change of hepatic function test (GGTP)
Time frame: Baseline, on the day after surgery, up to 2 weeks
Change of hepatic function tests (protein, albumin, fibrinogen)
Time frame: Baseline, on the day after surgery, up to 2 weeks
Change of PTI
Time frame: Baseline, on the day after surgery, up to 2 weeks
Change of renal function test (urea)
Time frame: Baseline, on the day after surgery, up to 2 weeks
Change of renal function test (creatinine)
Time frame: Baseline, on the day after surgery, up to 2 weeks
Number of patients whose cholecystectomy was delayed till next hospitalization because of the insufficient dynamics of decrease in bilirubinemia.
Time frame: Up to 2 weeks
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 21 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Gallstone Disease
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Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
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RecruitingObservational study
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gallstone Disease and Obstructive Jaundice, run by POLYSAN Scientific & Technological Pharmaceutical Company at 9 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 6 inclusion and 14 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 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Therapy response rate: decrease of total bilirubin level down to 20.5 µmol/l Visit 3 or decrease in total bilirubin by 70% compared to Visit 1. (time frame: Up to 2 weeks). 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 21 Apr 2026.