AzTrials
AzTrials

Chronic CholecystitisPhase 3NCT07595003

Efficacy, Safety, and Tolerability of 4-MUST, 128 mg Tablets in Chronic Cholecystitis and Biliary Dyskinesia

A Phase 3 study testing 4-MUST in people with Chronic Cholecystitis and Biliary Dyskinesia, run by Valenta Pharm JSC at 10 sites in Russia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The aim of the study is to evaluate the efficacy, safety, and tolerability of 4-MUST, 128 mg tablets compared to placebo in patients with chronic cholecystitis and biliary dyskinesia. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Chronic Cholecystitis, Biliary Dyskinesia
What is being tested?
4-MUST
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
10 sitesRussia
Study dates
12 Dec 2025to 31 Dec 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • Males and females aged 18-70 years.
  • Diagnosed with chronic cholecystitis (K81.1) and/or dyskinesia of the cystic duct or gallbladder (K82.8) prior to enrollment; diagnosis supported by clinical history of exacerbations and remissions and/or imaging/laboratory findings.
  • Upper abdominal pain or discomfort attributable to gallbladder or biliary tract dysfunction (per investigator assessment), accompanied by ≥1 of the following: heartburn, belching, nausea, abdominal bloating, borborygmi (stomach rumbling), flatulence, constipation, or diarrhea.
  • Maximum severity of pain/discomfort in the upper abdomen over the past week is 40 mm or more on the VAS (Visual Analog Scale).
  • Severity of gastrointestinal symptoms according to the GSRS (Gastrointestinal Symptom Rating Scale) questionnaire is at least 30 points.
  • The total bilirubin level does not exceed 2 times the upper limit of normal (no more than 42 μmol/L).
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  • Women who are either sexually abstinent or using effective contraception methods (e.g. intrauterine devices, contraceptive patches, long-acting injectable contraceptives, or double barrier methods) for at least 8 weeks before and 3 weeks after the end of the study, with a confirmed negative pregnancy test, as well as women with documented infertility or non-childbearing status (e.g. hysterectomy, tubal ligation, infertility or menopause for more than 1 year) or men using barrier contraceptives throughout the study and for 3 weeks after its completion, or men unable to conceive (documented conditions: vasectomy, infertility).
  • Signed and dated informed consent from.
  • Non-inclusion Criteria:
  • Gastric or duodenal ulcer, erosive gastroesophageal reflux disease (GERD), or other inflammatory/erosive gastrointestinal diseases in the acute stage, unless stable remission for ≥ 1 year since the last exacerbation.
  • Indication for surgical or endoscopic intervention due to exacerbation of chronic cholecystitis or complications of biliary tract dyskinesia.
  • Toxic megacolon.
  • Paralytic ileus.
  • Gilbert's syndrome.
  • Choledocholithiasis (or a high risk of its development, as determined by the investigator);
  • Impaired bile outflow due to adhesions in the abdominal cavity.Abdominal adhesion disease.
  • Irritable bowel syndrome, non-specific ulcerative colitis, Crohn's disease.
  • Gastrointestinal malignancy (including history of) or suspected gastrointestinal malignancy (e.g., blood in stool, unexplained weight loss, fever, anemia).
  • Any other oncological diseases known at the time of screening, or suspicion thereof.
  • History of gastrointestinal surgery, including cholecystectomy or endoscopic sphincterotomy (appendectomy excluded).
  • Use of prohibited therapy medications within 3 days prior to randomization.
  • History of mental illnesses.
  • Chronic heart failure IIb-III stages and/or III-IV functional classes according to NYHA, angina pectoris III-IV functional classes.
  • Chronic kidney disease stage IIIa-V (according to NKF/KDOQI, 2006).
  • History of or current hepatic impairment; or liver test abnormalities: AST, ALT, ALP, or GGT >3 above the upper limit of normal (ULN); total bilirubin >2 ULN or clinical jaundice.
  • HIV, syphilis, viral hepatitis B or C, including in history.
  • Lactose intolerance, lactase deficiency, and glucose-galactose malabsorption syndrome.
  • Liver cirrhosis.
  • Hypersensitivity to the active ingridient or any of the excipients of the drug 4-MUST.
  • Severe, decompensated, or unstable somatic conditions that are life-threatening, worsen prognosis, or preclude safe study participation.
  • Diabetes mellitus in a state of subcompensation and decompensation.
  • Systemic connective tissue diseases.
  • Autoimmune diseases.
  • Indication for hemodialysis procedures.
  • Epilepsy or seizures of unclear etiology, including in history.
  • Alcoholism, substance abuse or drug addiction, including in history.
  • Uncorrected electrolyte disturbances.
  • QTcF interval on a 12-lead electrocardiogram (ECG) ≥430 ms in men and ≥450 ms in women.
  • Episodes of constipation during the last 3 months that required the prescription of drug therapy.
  • History of surgery within 6 month prior to screening.
  • Women during pregnancy or lactation; women planning to become pregnant within the next 6 months.
  • Patients who require prohibited concomitant therapy within this study framework.
  • Participation in another clinical trial within the last 3 months prior to the screening visit date.
  • Unwillingness or inability to comply with study procedures and protocol requirements..
  • Other conditions that, in the investigator's judgement, may preclude the patient's participation in the study.

Who cannot join

  • Incorrect enrollment of a patient in the study (failure to meet inclusion/exclusion criteria at the time of randomization).
  • Lack of Efficacy. Study treatment will be discontinued if no clinical improvement is observed by Visit 3 (Day 15 ± 1), defined as persistence or worsening of upper abdominal pain/discomfort (assessed by Visual Analog Scale [VAS]) compared to baseline. Upon discontinuation, alternative therapy will be initiated at the investigator's discretion.
  • Patient non-compliance (a compliant patient is defined as one who has taken at least 202 and no more than 303 tablets).
  • Requirement for prohibited concomitant therapy.
  • Use of Duspatalin® (INN: mebeverine) for more than 3 consecutive days or for more than 5 days in total throughout the study.
  • If the investigator judges that comtinued participation in the study would harm the patient.
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  • Pregnancy or the need for breastfeeding.
  • Major protocol deviation by the subject with respect to procedures outlined in the Informed Consent Form (ICF).
  • Withdrawal of informed consent by the subject (decision to discontinue study participation).
  • Lost to follow-up: Inability to contact the subject after ≥3 documented attempts via mobile phone, landline (if applicable), and designated emergency contact.
  • Emergence during the study of any diseases or conditions that worsen the patient's prognosis, making it impossible for the patient to continue participating in this clinical trial.
  • Any other reasons, including administrative issues, that in the investigator's judgement may interfere with subject's ability to comlete the study.

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

10 sites in 1 country

Russia10 sites, 10 recruiting

  • State Budgetary Institution of Healthcare of Moscow "City Polyclinic No. 2 of the Moscow Department of Healthcare"

    Moscow, 117556

    Margarita Dorofeeva, MD, PhD, +7 (916) 128-99-78, margaritadorofeeva@yandex.ru

    Recruiting

  • Unimed-C Jsc

    Moscow, 119571

    Olga Orlova, MD, +7 (919) 994-90-14, orlelik@mail.ru

    Recruiting

  • The State Budgetary Healthcare Institution of the Moscow Region "Moscow Regional Research Clinical Institute named after M.F. Vladimirsky"

    Moscow

    Olga Kostyukevich, MD, PhD, +7 (916) 247-22-12, kostyukevich@mail.ru

    Recruiting

  • Limited Liability Company "ErSi Medical"

    Novosibirsk

    Anna Kosheleva, MD, +7-913-470-70-67, annkosheleva86@gmail.com

    Recruiting

  • Federal State Budgetary Educational Institution of Higher Education "Academician E.A. Wagner Perm State Medical University" of the Ministry of Healthcare of the Russian Federation

    Perm, 614990

    Natalia Osokina, MD, PhD, +7 (950) 460-96-74, kiselevanatalya8@mail.ru

    Recruiting

  • St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 117"

    Saint Petersburg, 194358

    Diana Alpenidze, MD,PhD, +7 (911) 760-51-15, d.alpenidze@mail.ru

    Recruiting

  • Limited Liability Company "Research Center Eco-Safety"

    Saint Petersburg, 196143

    Viktoria Dedkova, MD, +7 (931) 968-32-15, dedkova_va@ecosafety.ru

    Recruiting

  • Limited Liability Company "Research Center Eco-Safety"

    Saint Petersburg, 196143

    Vasiliy Vasilyuk, MD, PhD, +7 (901) 304 4248, vasilyuk_vb@ecosafety.ru

    Recruiting

  • Limited Liability Company "Clinic Zvezdnaya"

    Saint Petersburg, 196158

    Dmitry Shkarbul, MD, +7 (911) 218-10-55, director@starsclinic.ru

    Recruiting

  • State Healthcare Institution "Saratov City Clinical Hospital No. 5"

    Saratov, 410071

    Evgenii Orlikov, MD, +7 (906) 307-29-00, eorlikov@gmail.com

    Recruiting

Other trials in Russia

About this study

Official title: Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of 4-MUST, 128 mg Tablets in Patients With Chronic Cholecystitis and Biliary Tract Dyskinesia

The aim of the study is to evaluate the efficacy, safety, and tolerability of 4-MUST, 128 mg tablets compared to placebo in patients with chronic cholecystitis and biliary dyskinesia.

Being tested
4-MUST, Placebo
Medical subject headings
Biliary Dyskinesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 4-MUSTDrug

    Also called trimebutine 4-methylumbelliferyl sulfate

    128 mg of trimebutine 4-methylumbelliferyl sulfate tablet.

  • PlaceboDrug

    Placebo tablet.

Study groups in NCT07595003
Study groupRoleWhat they receive
4-MUSTExperimental4-MUST: 384 mg (3 tablets), orally three times a day (TID), 30 min before meals. Total daily dose - 1152 mg.
Receives: Drug: 4-MUST
PlaceboPlacebo comparatorPlacebo: 3 tablets, orally three times a day (TID), 30 min before meals.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean reduction in the severity of pain/discomfort in the upper abdomen on the VAS by day 29 compared to baseline

    Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"

    Measured: Day 29 ± 1

Secondary outcomes (65)

  1. Mean reduction in the severity of pain/discomfort in the upper abdomen according to VAS by days 2-28 from the start of therapy

    Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"

    Measured: Day 2 - Day 28

  2. Frequency of response to therapy (proportion of patients in the group with a reduction in the severity of pain/discomfort in the upper abdomen according to VAS by 30% or more) by days 8, 15, 22, and 29 following treatment initiation.

    Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"

    Measured: Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1

  3. Frequency of response to therapy (proportion of patients in the group with a reduction in the severity of pain/discomfort in the upper abdomen according to VAS by 50% or more) by days 8, 15, 22, and 29 following treatment initiation.

    Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"

    Measured: Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1

  4. Time to therapeutic response (reduction in the severity of pain/discomfort in the upper abdomen according to VAS by 30% or more)

    Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"

    Measured: Day 29 ± 1

  5. Time to therapeutic response (reduction in the severity of pain/discomfort in the upper abdomen according to VAS by 50% or more)

    Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"

    Measured: Day 29 ± 1

  6. Frequency of clinical recovery (proportion of patients in the group with a reduction in the severity of pain/discomfort in the upper abdomen according to VAS to 10 mm or less) by days 8, 15, 22, and 29 following treatment initiation.

    Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"

    Measured: Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1

  7. Time to clinical recovery (reduction in the severity of pain/discomfort in the upper abdomen according to VAS to 10 mm or less)

    Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"

    Measured: Day 29 ± 1

  8. Change in the total score of gastroenterological symptom severity according to the GSRS questionnaire by days 8, 15, 22, and 29 following treatment initiation.

    The Gastrointestinal Symptom Rating Scale (GSRS) is a self-administered questionnaire designed to assess gastrointestinal symptoms and their severity. It consists of 15 items categorized into five domains: Abdominal pain (including stomach pain and nausea), Reflux (heartburn and acid reflux), Indigestion (bloating, burping, and flatulence), Constipation (hard stools and incomplete evacuation), Diarrhea (loose stools and urgency). Respondents rate their symptoms on a 7-point Likert scale, where 1 indicates no discomfort and 7 indicates very severe discomfort.

    Measured: Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1

  9. Change in dyspeptic symptom severity, as assessed by the GSRS, expressed as score changes from baseline in the Abdominal Pain, Reflux, Indigestion, Diarrhea, and Constipation syndrome subscales at Days 8, 15, 22, and 29 following treatment initiation.

    The Gastrointestinal Symptom Rating Scale (GSRS) is a self-administered questionnaire designed to assess gastrointestinal symptoms and their severity. It consists of 15 items categorized into five domains: Abdominal pain (including stomach pain and nausea), Reflux (heartburn and acid reflux), Indigestion (bloating, burping, and flatulence), Constipation (hard stools and incomplete evacuation), Diarrhea (loose stools and urgency). Respondents rate their symptoms on a 7-point Likert scale, where 1 indicates no discomfort and 7 indicates very severe discomfort.

    Measured: Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1

  10. Change in the severity of individual symptoms of dyspeptic disorders according to the GSRS questionnaire in points by days 8, 15, 22, and 29 following treatment initiation.

    The Gastrointestinal Symptom Rating Scale (GSRS) is a self-administered questionnaire designed to assess gastrointestinal symptoms and their severity. It consists of 15 items categorized into five domains: Abdominal pain (including stomach pain and nausea), Reflux (heartburn and acid reflux), Indigestion (bloating, burping, and flatulence), Constipation (hard stools and incomplete evacuation), Diarrhea (loose stools and urgency). Respondents rate their symptoms on a 7-point Likert scale, where 1 indicates no discomfort and 7 indicates very severe discomfort.

    Measured: Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1

  11. Change in quality of life according to the total score on the SF-36 questionnaire by day 29 from treatment initiation.

    SF-36 (Short Form 36 Health Survey) is a self-reported questionnaire. It consists of 36 items that cover eight health domains: Physical functioning, Role limitations due to physical health, Role limitations due to emotional problems, Bodily pain, General health perceptions, Vitality (energy and fatigue), Social functioning, Mental health. SF-36 produces a profile of scores for each domain, which can be summarized into two main components: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Scores range from 0 to 100, where lower scores indicate greater disability and higher scores indicate better health.

    Measured: Day 29 ± 1

  12. Change in the total score on the PAGI-SYM questionnaire by days 15 and 29 from treatment initiation.

    PAGI-SYM (Patient Assessment of Upper Gastrointestinal Disorders-Symptom Severity Index) is a patient-reported questionnaire designed to assess the severity of symptoms in upper gastrointestinal disorders (GERD, dyspepsia, and gastroparesis). It consists of 20 items grouped into six subscales: Heartburn/Regurgitation, Fullness/Early Satiety, Nausea/Vomiting, Bloating, Upper Abdominal Pain, and Lower Abdominal Pain. Each symptom is rated on a 6-point Likert scale from 0 (none) to 5 (very severe). The questionnaire provides a profile of scores for each subscale, as well as a total score. Higher scores indicate greater symptom severity.

    Measured: Day 15 ± 1, and 29 ± 1

  13. change in the total score on the Visceral Sensitivity Index questionnaire by days 15 and 29 from the start of therapy

    VSI (Visceral Sensitivity Index) is a patient-reported questionnaire measuring gastrointestinal-specific anxiety (cognitive, affective, and behavioral responses to GI sensations). It consists of 15 items rated on a 6-point scale, producing a total score from 0 to 75. Higher scores indicate greater GI-specific anxiety. Originally validated in IBS patients, it is now used across various GI disorders.

    Measured: Day 15 ± 1, and 29 ± 1

  14. Change in the total score on the Emotional Distress - Depression - Short Form 4a questionnaire by days 8, 15, 22, and 29 from the start of therapy

    Emotional Distress - Depression - Short Form 4a (PROMIS Depression SF 4a) is a patient-reported questionnaire assessing depression symptoms over the past 7 days. It consists of 4 items rated on a 5-point scale. Raw scores (4-20) are converted to a standardized T-score (mean=50, SD=10). Higher scores indicate greater depression severity.

    Measured: Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1

  15. Safety and Tolerability: adverse event (AE) rate

    Frequency of adverse events (AEs) or serious AEs (SAEs)

    Measured: From screening (and signing informed consent form) to the end of the study (Day 36 ± 2)

  16. Safety and Tolerability: adverse event (AE) number

    Number of adverse events (AEs) or serious AEs (SAEs)

    Measured: From screening (and signing informed consent form) to the end of the study (Day 36 ± 2)

  17. Safety and Tolerability: AEs associated with the study drug

    Number and frequency of AEs associated with the study drug

    Measured: From screening (and signing informed consent form) to the end of the study (Day 36 ± 2)

  18. Safety and Tolerability: SAEs associated with the study drug

    Number and frequency of SAEs associated with the study drug

    Measured: From screening (and signing informed consent form) to the end of the study (Day 36 ± 2)

  19. Safety and Tolerability: treatment discontinuation

    Percentage of patients who discontinued treatment due to the occurrence of AEs/SAEs

    Measured: From screening (and signing informed consent form) to the end of the study (Day 36 ± 2)

  20. Safety and Tolerability: vital signs - systolic blood pressure (SBP)

    SBP, mmHg

    Measured: Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1

  21. Safety and Tolerability: vital signs - diastolic blood pressure (DBP)

    DBP, mmHg

    Measured: Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1

  22. Safety and Tolerability: vital signs - respiratory rate (RR)

    RR, breaths per minute

    Measured: Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1

  23. Safety and Tolerability: vital signs - heart rate (HR)

    HR, beats per minute

    Measured: Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1

  24. Safety and Tolerability: vital signs - body temperature

    Body temperature, Celsius scale

    Measured: Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1

  25. Physical examination results: cardiovascular system

    An assessment of the condition of the cardiovascular system on physical examination (normal condition or list of abnormal conditions, if any)

    Measured: Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1

  26. Physical examination results: respiratory system

    An assessment of the condition of the respiratory system on physical examination (normal condition or list of abnormal conditions, if any)

    Measured: Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1

  27. Physical examination results: digestive tract

    An assessment of the condition of the digestive tract on physical examination (normal condition or list of abnormal conditions, if any)

    Measured: Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1

  28. Physical examination results: endocrine system

    An assessment of the condition of the endocrine system on physical examination (normal condition or list of abnormal conditions, if any)

    Measured: Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1

  29. Physical examination results: musculoskeletal system

    An assessment of the condition of the musculoskeletal system on physical examination (normal condition or list of abnormal conditions, if any)

    Measured: Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1

  30. Physical examination results: nervous system

    An assessment of the condition of the nervous system on physical examination (normal condition or list of abnormal conditions, if any)

    Measured: Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1

  31. Physical examination results: sensory systems

    An assessment of the condition of the sensory systems on physical examination (normal condition or list of abnormal conditions, if any)

    Measured: Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1

  32. Physical examination results: skin/visible mucous membranes

    An assessment of the condition of the skin/visible mucous membranes on physical examination (normal condition or list of abnormal conditions, if any)

    Measured: Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1

  33. Results of laboratory and instrumental examinations: clinical blood test - hemoglobin

    Hemoglobin (g/L)

    Measured: Screening, day 15 ± 1, day 29 ± 1

  34. Results of laboratory and instrumental examinations: clinical blood test - hematocrit

    Hematocrit (%)

    Measured: Screening, day 15 ± 1, day 29 ± 1

  35. Results of laboratory and instrumental examinations: clinical blood test - red blood cell count

    Red blood cell count (cells/L)

    Measured: Screening, day 15 ± 1, day 29 ± 1

  36. Results of laboratory and instrumental examinations: clinical blood test - platelet count

    Platelet count (cells/L)

    Measured: Screening, day 15 ± 1, day 29 ± 1

  37. Results of laboratory and instrumental examinations: clinical blood test - leukocyte count

    Leukocyte count (cells/L)

    Measured: Screening, day 15 ± 1, day 29 ± 1

  38. Results of laboratory and instrumental examinations: clinical blood test - erythrocyte sedimentation rate

    Erythrocyte sedimentation rate (mm/h)

    Measured: Screening, day 15 ± 1, day 29 ± 1

  39. Results of laboratory and instrumental examinations: clinical blood test - myelocytes

    Leukocyte formula (myelocytes, %)

    Measured: Screening, day 15 ± 1, day 29 ± 1

  40. Results of laboratory and instrumental examinations: clinical blood test - band neutrophils

    Leukocyte formula (band neutrophils, %)

    Measured: Screening, day 15 ± 1, day 29 ± 1

  41. Results of laboratory and instrumental examinations: clinical blood test - segmented neutrophils

    Leukocyte formula (segmented neutrophils, %)

    Measured: Screening, day 15 ± 1, day 29 ± 1

  42. Results of laboratory and instrumental examinations: clinical blood test - eosinophils

    Leukocyte formula (eosinophils, %)

    Measured: Screening, day 15 ± 1, day 29 ± 1

  43. Results of laboratory and instrumental examinations: clinical blood test - basophils

    Leukocyte formula (basophils, %)

    Measured: Screening, day 15 ± 1, day 29 ± 1

  44. Results of laboratory and instrumental examinations: clinical blood test - monocytes

    Leukocyte formula (monocytes, %)

    Measured: Screening, day 15 ± 1, day 29 ± 1

  45. Results of laboratory and instrumental examinations: clinical blood test - lymphocytes

    Leukocyte formula (lymphocytes, %)

    Measured: Screening, day 15 ± 1, day 29 ± 1

  46. Results of laboratory and instrumental examinations: blood chemistry - glucose

    Glucose concentration (mmol/L)

    Measured: Screening, day 15 ± 1, day 29 ± 1

  47. Results of laboratory and instrumental examinations: blood chemistry - cholesterol

    Total cholesterol concentration (mmol/L)

    Measured: Screening, day 15 ± 1, day 29 ± 1

  48. Results of laboratory and instrumental examinations: blood chemistry - protein

    Total protein concentration (g/L)

    Measured: Screening, day 15 ± 1, day 29 ± 1

  49. Results of laboratory and instrumental examinations: blood chemistry - bilirubin

    Total bilirubin concentration (micromol/L)

    Measured: Screening, day 15 ± 1, day 29 ± 1

  50. Results of laboratory and instrumental examinations: blood chemistry - creatinine

    Creatinine concentration (micromol/L)

    Measured: Screening, day 15 ± 1, day 29 ± 1

  51. Results of laboratory and instrumental examinations: blood chemistry - alkaline phosphatase

    Alkaline phosphatase activity (U/L)

    Measured: Screening, day 15 ± 1, day 29 ± 1

  52. Results of laboratory and instrumental examinations: blood chemistry - alanine transaminase

    Alanine transaminase activity (U/L)

    Measured: Screening, day 15 ± 1, day 29 ± 1

  53. Results of laboratory and instrumental examinations: blood chemistry - aspartate transaminase

    Aspartate transaminase activity (U/L)

    Measured: Screening, day 15 ± 1, day 29 ± 1

  54. Results of laboratory and instrumental examinations: blood chemistry - gamma-GTP

    Gamma-glutaryl transpeptidase activity (U/L)

    Measured: Screening, day 15 ± 1, day 29 ± 1

  55. Results of laboratory and instrumental examinations: blood chemistry - CRP

    C-reactive protein, CRP (mg/L)

    Measured: Screening, day 15 ± 1, day 29 ± 1

  56. Results of laboratory and instrumental examinations: urinalysis - specific gravity

    Specific gravity of the urine

    Measured: Screening, day 15 ± 1, day 29 ± 1

  57. Results of laboratory and instrumental examinations: urinalysis - pH

    pH of the urine

    Measured: Screening, day 15 ± 1, day 29 ± 1

  58. Results of laboratory and instrumental examinations: urinalysis - protein

    Protein concentration (g/L)

    Measured: Screening, day 15 ± 1, day 29 ± 1

  59. Results of laboratory and instrumental examinations: urinalysis - glucose

    Glucose concentration (mmol/L)

    Measured: Screening, day 15 ± 1, day 29 ± 1

  60. Results of laboratory and instrumental examinations: urinalysis - red blood cells

    Red blood cell content (number in sight)

    Measured: Screening, day 15 ± 1, day 29 ± 1

  61. Results of laboratory and instrumental examinations: urinalysis - white blood cells

    White blood cell content (number in sight)

    Measured: Screening, day 15 ± 1, day 29 ± 1

  62. Safety and Tolerability: 12-lead electrocardiogram (ECG) - heart rate

    12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: heart rate (beats per minute)

    Measured: Screening, day 1, day 29 ± 1

  63. Safety and Tolerability: 12-lead electrocardiogram (ECG) - PQ interval

    12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: PQ interval (is the period, measured in milliseconds, that extends from the beginning of the P wave (the onset of atrial depolarization) until the beginning of the QRS complex)

    Measured: Screening, day 1, day 29 ± 1

  64. Safety and Tolerability: 12-lead electrocardiogram (ECG) - QRS complex

    12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: QRS complex (the QRS complex is the combination of three of the graphical deflections seen on a typical electrocardiogram)

    Measured: Screening, day 1, day 29 ± 1

  65. Safety and Tolerability: 12-lead electrocardiogram (ECG) - corrected QT interval

    12-lead ECG (I, II, III, aVR-enhanced unipolar abduction from the right arm , aVL-enhanced unipolar abduction from the left arm, aVF - enhanced unipolar abduction from the left leg, V1-V6) taken while lying down: corrected QT interval (distance from the beginning of the QRS complex to the end of the T wave) (Frederica correction)

    Measured: Screening, day 1, day 29 ± 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2026
  2. Study start12 Dec 2025
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07595003
Sponsor's protocol ID
GIB-03-04-2025
Status last verified
Mar 2026
First submitted
12 May 2026
Last updated
19 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 4-MUST in people with Chronic Cholecystitis and Biliary Dyskinesia, run by Valenta Pharm JSC at 10 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 45 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean reduction in the severity of pain/discomfort in the upper abdomen on the VAS by day 29 compared to baseline (time frame: Day 29 ± 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07595003.

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 19 May 2026.

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