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AzTrials

Chronic CholecystitisPhase 2NCT06842966

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

A Phase 2 study testing 4-MUST in people with Chronic Cholecystitis and Biliary Dyskinesia, run by Valenta Pharm JSC at 17 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

This study aims to evaluate the efficacy, safety, and tolerability of the drug 4-MUST at various doses 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
17 sitesRussia
Study dates
17 Oct 2024to 31 Dec 2026
Phase
Phase 2
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.
  • Presence of established gastrointestinal diseases: Chronic cholecystitis (K81.1); Dyskinesia of the bile duct or gallbladder (K82.8).
  • Presence of pain/discomfort in the upper abdomen combined with at least one of the following symptoms: Heartburn; Belching; Nausea; Abdominal bloating; Borborygmi (stomach rumbling); Flatulence; Constipation; 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.
  • 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).
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  • Signed and dated informed consent from.
  • Non-inclusion Criteria:
  • Peptic ulcer disease, duodenal ulcer, erosive GERD.
  • Toxic megacolon.
  • Paralytic ileus.
  • Gilbert's syndrome.
  • Abdominal adhesion disease.
  • Blood in stool, unexplained weight loss, fever, anemia.
  • Inflammatory and erosive gastrointestinal diseases.
  • Irritable bowel syndrome, non-specific ulcerative colitis, Crohn's disease.
  • Oncological diseases of the gastrointestinal tract (including past diagnoses).
  • History of gastrointestinal surgical procedures, including but not limited to endoscopic papillotomy and cholecystectomy, exept for appendectomy.
  • 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).
  • Established diagnosis of liver failure, including in history and/or changes in liver enzyme activity: Increase in AST, ALT, ALP and/or γ-GTP more than 3 times above the upper limit of normal; Increase in total bilirubin more than 2 times above the upper limit of normal or development of 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 diseases (any diseases or conditions that threaten the patient's life or worsen their prognosis and make it impossible for the patient to participate in clinical research).
  • Diabetes mellitus in a state of subcompensation and decompensation.
  • Systemic connective tissue diseases.
  • Autoimmune diseases.
  • Need for surgical and/or endovascular treatment and/or necessity for hemodialysis procedures.
  • Epilepsy or seizures of unclear etiology, including in history.
  • Alcoholism, substance abuse or drug addiction, including in history.
  • Uncorrected electrolyte disturbances.
  • 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.
  • Lack of willingness to cooperate from the patient's side.
  • 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).
  • Ineffectiveness of therapy. The therapy will be deemed ineffective if there is no clinical improvement by visit 3 (15±1 days of therapy) - persistence or increase in the severity of pain/discomfort in the upper abdomen on the VAS compared to baseline. If excluded, the patient will be assigned alternative treatment at the discretion of the investigator.
  • 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.
  • If the investigator judges that comtinued participation in the study would harm the patient.
  • Pregnancy or the need for breastfeeding in the patient.
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  • Gross violation by the patient of the study protocol procedures outlined in the patient information sheet (PIS).
  • Withdrawal of informed consent (patient's unwillingness to continue participation in the study).
  • Loss of contact with the patient (inability to reach the patient via mobile and home phone (if applicable), as well as through a contact person; there must be at least three documented attempts to contact the patient).
  • 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

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

17 sites in 1 country

Russia17 sites, 17 recruiting

  • State autonomous health care institution "Engels City Clinical Hospital No. 1"

    Engel's, 413116

    Ekaterina Muldagalieva, MD, +7 (8453) 51-59-02, katyfily@yandex.ru

    Recruiting

  • Ivanovo Kuvaev Clinical Hospital

    Ivanovo, 153025

    Svetlana Ushakova, MD, PhD, +7 (910) 992 3962, svetland1962@mail.ru

    Recruiting

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

    Moscow, 117556

    Natalia Lapidus, MD, PhD, +7-499-317-00-45, nat_lap@mail.ru

    Recruiting

  • Unimed-C Jsc

    Moscow, 119571

    Elena Volnaya, MD, +7-495-135-50-10, drvolnaya@yandex.ru

    Recruiting

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

    Moscow

    Svetlana Erofeeva, MD, +7-499-674-07-09, erofsb@mail.ru

    Recruiting

  • Limited Liability Company "ErSi Medical"

    Novosibirsk

    Natalya Voloshina, MD, PhD, +7-383-388-41-12, voloshinanatalya@yandex.ru

    Recruiting

  • Professors' Clinic LLC.

    Perm, 614070

    Svetlana Teplykh, MD, PhD, +7 (919) 498 2931, profkliniki@mail.ru

    Recruiting

  • Limited Liability Company "Medical Center Eco-Safety"

    Saint Petersburg, 19119

    Vasiliy Vasilyuk, MD,PhD, Prof., +7 (812) 500-52-03 ext. 5001, vasilyuk_vb@ecosafety.ru

    Recruiting

  • Limited Liability Company "Energy of Health"

    Saint Petersburg, 194156

    Evgeny Levchenko, MD, +7-812-701-03-03, lev2096@yandex.ru

    Recruiting

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

    Saint Petersburg, 194358

    Diana Alpenidze, MD,PhD, +7 (812) 246-73-10, d.alpenidze@mail.ru

    Recruiting

  • Limited Liability Company "Clinic Zvezdnaya"

    Saint Petersburg, 196158

    Dmitry Shkarbul, MD, +7 (812) 407-32-32, director@starsclinic.ru

    Recruiting

  • Limited Liability Company "Meili"

    Saint Petersburg, 199406

    Maria Bolotova, MD, +7-921-331-29-92, mbolotova75@mail.ru

    Recruiting

  • State Budgetary Institution "St. Petersburg Research Institute of Emergency Care named after I.I. Djanelidze"

    Saint Petersburg

    Victor Kostenko, MD, PhD, +7-812-406-88-88, victor.kostenko@hotmail.com

    Recruiting

  • Private institution of higher education "Medical University 'Reavis'"

    Samara

    Elena Bunkova, MD, +7-800-600-24-00, bunkova27@mail.ru

    Recruiting

  • Association "Regional Medical Center 'Open Medicine'"

    Tolyatti

    Alexey Frolov, MD, +7-8482-55-10-00, frolovalexej@yandex.ru

    Recruiting

  • LLC "Polyclinic Polimedika Veliky Novgorod"

    Velikiy Novgorod

    Olga Solovjova, MD, PhD, +7-812-303-50-00, o_solovjova@inbox.ru

    Recruiting

  • Limited Liability Company "Medical Center for Diagnosis and Prevention Plus"

    Yaroslavl

    Ekaterina Melnikova, MD, PhD, +7-4852-58-88-28, melnicovae@mail.ru

    Recruiting

Other trials in Russia

About this study

Official title: A Prospective Multicenter Randomized Double-blind Placebo-controlled Study in Parallel Groups to Evaluate the Efficacy, Safety, and Tolerability of the Drug 4-MUST, Tablets, 128 mg Administered at Various Doses in Patients With Chronic Cholecystitis and Biliary Dyskinesia

This study aims to evaluate the efficacy, safety, and tolerability of the drug 4-MUST at various doses 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 NCT06842966
Study groupRoleWhat they receive
4-MUST, 128 mgExperimentalPatients will receive 1 tablet of the drug 4-MUST (128 mg of trimebutine 4-methylumbelliferyl sulfate) and 2 placebo tablets three times a day.
Receives: Drug: 4-MUST; Drug: Placebo
4-MUST, 256 mgExperimentalPatients will receive 2 tablets of the drug 4-MUST (256 mg of trimebutine 4-methylumbelliferyl sulfate) and 1 placebo tablet three times a day.
Receives: Drug: 4-MUST; Drug: Placebo
4-MUST, 384 mgExperimentalPatients will receive 3 tablets of the drug 4-MUST (384 mg of trimebutine 4-methylumbelliferyl sulfate) three times a day.
Receives: Drug: 4-MUST
PlaceboPlacebo comparatorPatients will receive 3 placebo tablets three times a day.
Receives: Drug: Placebo

What is being measured

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

  1. Average 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 (56)

  1. Change in the total score of gastrointestinal symptom severity according to the GSRS questionnaire on days 8, 15, 22, and 29 compared to baseline

    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

  2. Response rate to therapy (proportion of patients in the group showing a reduction in pain/discomfort in the upper abdomen on the VAS by more than 30%) 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

  3. Response rate to therapy (proportion of patients in the group showing a reduction in pain/discomfort in the upper abdomen on the VAS by 50% or more) 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

  4. Change in manifestations of dyspeptic disorders according to the GSRS questionnaire scores on days 8, 15, 22, and 29 compared to baseline

    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

  5. Change in quality of life based on the total score from the SF-36 questionnaire by day 29 compared to baseline

    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

  6. Average reduction in pain/discomfort severity in the upper abdomen on the VAS by days 8, 15, and 22 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 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1

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

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

    Measured: From the date of screening (and signing informed consent form) to the end of the study or to an early termination visit, whichever came first, assessed up to day 36 ± 2 for each participant

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

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

    Measured: From the date of screening (and signing informed consent form) to the end of the study or to an early termination visit, whichever came first, assessed up to day 36 ± 2 for each participant

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

    Number and frequency of AEs associated with the study drug

    Measured: From the date of screening (and signing informed consent form) to the end of the study or to an early termination visit, whichever came first, assessed up to day 36 ± 2 for each participant

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

    Number and frequency of SAEs associated with the study drug

    Measured: From the date of screening (and signing informed consent form) to the end of the study or to an early termination visit, whichever came first, assessed up to day 36 ± 2 for each participant

  11. Safety and Tolerability: treatment discontinuation

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

    Measured: From the date of screening (and signing informed consent form) to the end of the study or to an early termination visit, whichever came first, assessed up to day 36 ± 2 for each participant

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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)(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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

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

    Hemoglobin (g/L)

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

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

    Hematocrit (%)

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

  27. 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

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

    Platelet count (cells/L)

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

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

    Leukocyte count (cells/L)

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

  30. 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

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

    Leukocyte formula (myelocytes, %)

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

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

    Leukocyte formula (band neutrophils, %)

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

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

    Leukocyte formula (segmented neutrophils, %)

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

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

    Leukocyte formula (eosinophils, %)

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

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

    Leukocyte formula (basophils, %)

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

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

    Leukocyte formula (monocytes, %)

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

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

    Leukocyte formula (lymphocytes, %)

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

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

    Glucose concentration (mmol/L)

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

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

    Total cholesterol concentration (mmol/L)

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

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

    Total protein concentration (g/L)

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

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

    Total bilirubin concentration (micromol/L)

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

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

    Creatinine concentration (micromol/L)

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

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

    Alkaline phosphatase activity (U/L)

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

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

    Alanine transaminase activity (U/L)

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

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

    Aspartate transaminase activity (U/L)

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

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

    Gamma-glutaryl transpeptidase activity (U/L)

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

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

    Specific gravity of the urine

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

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

    pH of the urine

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

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

    Protein concentration (g/L)

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

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

    Glucose concentration (mmol/L)

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

  51. 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

  52. 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

  53. 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 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1

  54. 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 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1

  55. 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 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1

  56. 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 8 ± 1, day 15 ± 1, day 22 ± 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 posted24 Feb 2025
  2. Study start17 Oct 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (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 2
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
NCT06842966
Sponsor's protocol ID
GIB-02-03-2024
Status last verified
Jul 2025
First submitted
17 Feb 2025
Last updated
11 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 4-MUST in people with Chronic Cholecystitis and Biliary Dyskinesia, run by Valenta Pharm JSC at 17 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 41 inclusion and 11 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 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Average 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 NCT06842966.

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 11 Jul 2025.

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