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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4-MUST | Experimental | 4-MUST: 384 mg (3 tablets), orally three times a day (TID), 30 min before meals. Total daily dose - 1152 mg. |
|
| Placebo | Placebo Comparator | Placebo: 3 tablets, orally three times a day (TID), 30 min before meals. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4-MUST | Drug | 128 mg of trimebutine 4-methylumbelliferyl sulfate tablet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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" | Day 29 ± 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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" | Day 2 - Day 28 |
| 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. |
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Inclusion Criteria:
Non-inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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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| Placebo | Drug | Placebo tablet. |
|
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 |
| 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" | Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1 |
| 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" | Day 29 ± 1 |
| 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" | Day 29 ± 1 |
| 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" | Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1 |
| 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" | Day 29 ± 1 |
| 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. | Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1 |
| 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. | Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1 |
| 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. | Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1 |
| 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. | Day 29 ± 1 |
| 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. | Day 15 ± 1, and 29 ± 1 |
| 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. | Day 15 ± 1, and 29 ± 1 |
| 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. | 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 screening (and signing informed consent form) to the end of the study (Day 36 ± 2) |
| Safety and Tolerability: adverse event (AE) number | Number of adverse events (AEs) or serious AEs (SAEs) | From screening (and signing informed consent form) to the end of the study (Day 36 ± 2) |
| Safety and Tolerability: AEs associated with the study drug | Number and frequency of AEs associated with the study drug | From screening (and signing informed consent form) to the end of the study (Day 36 ± 2) |
| Safety and Tolerability: SAEs associated with the study drug | Number and frequency of SAEs associated with the study drug | From screening (and signing informed consent form) to the end of the study (Day 36 ± 2) |
| Safety and Tolerability: treatment discontinuation | Percentage of patients who discontinued treatment due to the occurrence of AEs/SAEs | From screening (and signing informed consent form) to the end of the study (Day 36 ± 2) |
| 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) | 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: blood chemistry - CRP | C-reactive protein, CRP (mg/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 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 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 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 29 ± 1 |
| 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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| 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 | Recruiting | Perm | 614990 | 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 "Research Center Eco-Safety" | Recruiting | Saint Petersburg | 196143 | Russia |
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| Limited Liability Company "Research Center Eco-Safety" | Recruiting | Saint Petersburg | 196143 | Russia |
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| Limited Liability Company "Clinic Zvezdnaya" | Recruiting | Saint Petersburg | 196158 | Russia |
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| State Healthcare Institution "Saratov City Clinical Hospital No. 5" | Recruiting | Saratov | 410071 | 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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