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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4-MUST, 128 mg | Experimental | Patients will receive 1 tablet of the drug 4-MUST (128 mg of trimebutine 4-methylumbelliferyl sulfate) and 2 placebo tablets three times a day. |
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| 4-MUST, 256 mg | Experimental | Patients will receive 2 tablets of the drug 4-MUST (256 mg of trimebutine 4-methylumbelliferyl sulfate) and 1 placebo tablet three times a day. |
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| 4-MUST, 384 mg | Experimental | Patients will receive 3 tablets of the drug 4-MUST (384 mg of trimebutine 4-methylumbelliferyl sulfate) three times a day. |
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| Placebo | Placebo Comparator | Patients will receive 3 placebo tablets three times a day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4-MUST | Drug | 128 mg of trimebutine 4-methylumbelliferyl sulfate tablet. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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" | Day 29 ± 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Non-inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State autonomous health care institution "Engels City Clinical Hospital No. 1" | Recruiting | Engel's | 413116 | Russia |
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| Placebo | Drug | Placebo tablet. |
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| Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1 |
| 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" | Day 29 ± 1 |
| 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" | Day 29 ± 1 |
| 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. | Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1 |
| 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. | Day 29 ± 1 |
| 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" | Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1 |
| Safety and Tolerability: adverse event (AE) rate | Frequency of adverse events (AEs) or serious AEs (SAEs) | 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 |
| Safety and Tolerability: adverse event (AE) number | Number of adverse events (AEs) or serious AEs (SAEs) | 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 |
| Safety and Tolerability: AEs associated with the study drug | Number and frequency of AEs associated with the study drug | 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 |
| Safety and Tolerability: SAEs associated with the study drug | Number and frequency of SAEs associated with the study drug | 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 |
| Safety and Tolerability: treatment discontinuation | Percentage of patients who discontinued treatment due to the occurrence of AEs/SAEs | 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 |
| Safety and Tolerability: vital signs - systolic blood pressure (SBP) | SBP, mmHg | Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1 |
| Safety and Tolerability: vital signs - diastolic blood pressure (DBP) | DBP, mmHg | Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1 |
| Safety and Tolerability: vital signs - respiratory rate (RR) | RR, breaths per minute | Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1 |
| Safety and Tolerability: vital signs - heart rate (HR) | HR, beats per minute | Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1 |
| Safety and Tolerability: vital signs - body temperature | Body temperature, Celsius scale | Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1 |
| 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) | Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1 |
| 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) | Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1 |
| 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) | Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1 |
| 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) | Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1 |
| 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) | Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1 |
| 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) | Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1 |
| 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) | Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1 |
| 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) | Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1 |
| Results of laboratory and instrumental examinations: clinical blood test - hemoglobin | Hemoglobin (g/L) | Screening, day 15 ± 1, day 29 ± 1 |
| Results of laboratory and instrumental examinations: clinical blood test - hematocrit | Hematocrit (%) | Screening, day 15 ± 1, day 29 ± 1 |
| Results of laboratory and instrumental examinations: clinical blood test - red blood cell count | Red blood cell count (cells/L) | Screening, day 15 ± 1, day 29 ± 1 |
| Results of laboratory and instrumental examinations: clinical blood test - platelet count | Platelet count (cells/L) | Screening, day 15 ± 1, day 29 ± 1 |
| Results of laboratory and instrumental examinations: clinical blood test - leukocyte count | Leukocyte count (cells/L) | Screening, day 15 ± 1, day 29 ± 1 |
| Results of laboratory and instrumental examinations: clinical blood test - erythrocyte sedimentation rate | Erythrocyte sedimentation rate (mm/h) | Screening, day 15 ± 1, day 29 ± 1 |
| Results of laboratory and instrumental examinations: clinical blood test - myelocytes | Leukocyte formula (myelocytes, %) | Screening, day 15 ± 1, day 29 ± 1 |
| Results of laboratory and instrumental examinations: clinical blood test - band neutrophils | Leukocyte formula (band neutrophils, %) | Screening, day 15 ± 1, day 29 ± 1 |
| Results of laboratory and instrumental examinations: clinical blood test - segmented neutrophils | Leukocyte formula (segmented neutrophils, %) | Screening, day 15 ± 1, day 29 ± 1 |
| Results of laboratory and instrumental examinations: clinical blood test - eosinophils | Leukocyte formula (eosinophils, %) | Screening, day 15 ± 1, day 29 ± 1 |
| Results of laboratory and instrumental examinations: clinical blood test - basophils | Leukocyte formula (basophils, %) | Screening, day 15 ± 1, day 29 ± 1 |
| Results of laboratory and instrumental examinations: clinical blood test - monocytes | Leukocyte formula (monocytes, %) | Screening, day 15 ± 1, day 29 ± 1 |
| Results of laboratory and instrumental examinations: clinical blood test - lymphocytes | Leukocyte formula (lymphocytes, %) | Screening, day 15 ± 1, day 29 ± 1 |
| Results of laboratory and instrumental examinations: blood chemistry - glucose | Glucose concentration (mmol/L) | Screening, day 15 ± 1, day 29 ± 1 |
| Results of laboratory and instrumental examinations: blood chemistry - cholesterol | Total cholesterol concentration (mmol/L) | Screening, day 15 ± 1, day 29 ± 1 |
| Results of laboratory and instrumental examinations: blood chemistry - protein | Total protein concentration (g/L) | Screening, day 15 ± 1, day 29 ± 1 |
| Results of laboratory and instrumental examinations: blood chemistry - bilirubin | Total bilirubin concentration (micromol/L) | Screening, day 15 ± 1, day 29 ± 1 |
| Results of laboratory and instrumental examinations: blood chemistry - creatinine | Creatinine concentration (micromol/L) | Screening, day 15 ± 1, day 29 ± 1 |
| Results of laboratory and instrumental examinations: blood chemistry - alkaline phosphatase | Alkaline phosphatase activity (U/L) | Screening, day 15 ± 1, day 29 ± 1 |
| Results of laboratory and instrumental examinations: blood chemistry - alanine transaminase | Alanine transaminase activity (U/L) | Screening, day 15 ± 1, day 29 ± 1 |
| Results of laboratory and instrumental examinations: blood chemistry - aspartate transaminase | Aspartate transaminase activity (U/L) | Screening, day 15 ± 1, day 29 ± 1 |
| Results of laboratory and instrumental examinations: blood chemistry - gamma-GTP | Gamma-glutaryl transpeptidase activity (U/L) | Screening, day 15 ± 1, day 29 ± 1 |
| Results of laboratory and instrumental examinations: urinalysis - specific gravity | Specific gravity of the urine | Screening, day 15 ± 1, day 29 ± 1 |
| Results of laboratory and instrumental examinations: urinalysis - pH | pH of the urine | Screening, day 15 ± 1, day 29 ± 1 |
| Results of laboratory and instrumental examinations: urinalysis - protein | Protein concentration (g/L) | Screening, day 15 ± 1, day 29 ± 1 |
| Results of laboratory and instrumental examinations: urinalysis - glucose | Glucose concentration (mmol/L) | Screening, day 15 ± 1, day 29 ± 1 |
| Results of laboratory and instrumental examinations: urinalysis - red blood cells | Red blood cell content (number in sight) | Screening, day 15 ± 1, day 29 ± 1 |
| Results of laboratory and instrumental examinations: urinalysis - white blood cells | White blood cell content (number in sight) | Screening, day 15 ± 1, day 29 ± 1 |
| 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) | Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1 |
| 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) | Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1 |
| 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) | Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1 |
| 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) | Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1 |
| Ivanovo Kuvaev Clinical Hospital | Recruiting | Ivanovo | 153025 | Russia |
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| State Budgetary Institution of Healthcare of Moscow "City Polyclinic No. 2 of the Moscow Department of Healthcare" | Recruiting | Moscow | 117556 | Russia |
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| Unimed-C Jsc | Recruiting | Moscow | 119571 | Russia |
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| The State Budgetary Healthcare Institution of the Moscow Region "Moscow Regional Research Clinical Institute named after M.F. Vladimirsky" | Recruiting | Moscow | Russia |
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| Limited Liability Company "ErSi Medical" | Recruiting | Novosibirsk | Russia |
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| Professors' Clinic LLC. | Recruiting | Perm | 614070 | Russia |
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| Limited Liability Company "Medical Center Eco-Safety" | Recruiting | Saint Petersburg | 19119 | Russia |
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| Limited Liability Company "Energy of Health" | Recruiting | Saint Petersburg | 194156 | Russia |
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| St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 117" | Recruiting | Saint Petersburg | 194358 | Russia |
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| Limited Liability Company "Clinic Zvezdnaya" | Recruiting | Saint Petersburg | 196158 | Russia |
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| Limited Liability Company "Meili" | Recruiting | Saint Petersburg | 199406 | Russia |
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| State Budgetary Institution "St. Petersburg Research Institute of Emergency Care named after I.I. Djanelidze" | Recruiting | Saint Petersburg | Russia |
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| Private institution of higher education "Medical University 'Reavis'" | Recruiting | Samara | Russia |
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| Association "Regional Medical Center 'Open Medicine'" | Recruiting | Tolyatti | Russia |
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| LLC "Polyclinic Polimedika Veliky Novgorod" | Recruiting | Veliky Novgorod | Russia |
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| Limited Liability Company "Medical Center for Diagnosis and Prevention Plus" | Recruiting | Yaroslavl | Russia |
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| ID | Term |
|---|---|
| D001657 | Biliary Dyskinesia |
| ID | Term |
|---|---|
| D003137 | Common Bile Duct Diseases |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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