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

July 7, 2025 updated by: Valenta Pharm JSC

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Engels, Russian Federation, 413116
        • Recruiting
        • State autonomous health care institution "Engels City Clinical Hospital No. 1"
        • Contact:
      • Ivanovo, Russian Federation, 153025
        • Recruiting
        • Ivanovo Kuvaev Clinical Hospital
        • Contact:
      • Moscow, Russian Federation, 117556
        • Recruiting
        • State Budgetary Institution of Healthcare of Moscow "City Polyclinic No. 2 of the Moscow Department of Healthcare"
        • Contact:
          • Natalia Lapidus, MD, PhD
          • Phone Number: +7-499-317-00-45
          • Email: nat_lap@mail.ru
      • Moscow, Russian Federation, 119571
        • Recruiting
        • Unimed-C Jsc
        • Contact:
      • Moscow, Russian Federation
        • Recruiting
        • The State Budgetary Healthcare Institution of the Moscow Region "Moscow Regional Research Clinical Institute named after M.F. Vladimirsky"
        • Contact:
          • Svetlana Erofeeva, MD
          • Phone Number: +7-499-674-07-09
          • Email: erofsb@mail.ru
      • Novosibirsk, Russian Federation
        • Recruiting
        • Limited Liability Company "ErSi Medical"
        • Contact:
      • Perm, Russian Federation, 614070
        • Recruiting
        • Professors' Clinic LLC.
        • Contact:
      • Saint Petersburg, Russian Federation, 194156
        • Recruiting
        • Limited Liability Company "Energy of Health"
        • Contact:
      • Saint Petersburg, Russian Federation, 199406
        • Recruiting
        • Limited Liability Company "Meili"
        • Contact:
      • Saint Petersburg, Russian Federation, 194358
        • Recruiting
        • St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 117"
        • Contact:
      • Saint Petersburg, Russian Federation, 196158
        • Recruiting
        • Limited Liability Company "Clinic Zvezdnaya"
        • Contact:
      • Saint Petersburg, Russian Federation
        • Recruiting
        • State Budgetary Institution "St. Petersburg Research Institute of Emergency Care named after I.I. Djanelidze"
        • Contact:
      • Samara, Russian Federation
        • Recruiting
        • Private institution of higher education "Medical University 'Reavis'"
        • Contact:
      • St. Petersburg, Russian Federation, 19119
        • Recruiting
        • Limited Liability Company "Medical Center Eco-Safety"
        • Contact:
      • Tol'yatti, Russian Federation
        • Recruiting
        • Association "Regional Medical Center 'Open Medicine'"
        • Contact:
      • Veliky Novgorod, Russian Federation
        • Recruiting
        • LLC "Polyclinic Polimedika Veliky Novgorod"
        • Contact:
      • Yaroslavl, Russian Federation
        • Recruiting
        • Limited Liability Company "Medical Center for Diagnosis and Prevention Plus"
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Males and females aged 18-70 years.
  2. Presence of established gastrointestinal diseases: Chronic cholecystitis (K81.1); Dyskinesia of the bile duct or gallbladder (K82.8).
  3. 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.
  4. Maximum severity of pain/discomfort in the upper abdomen over the past week is 40 mm or more on the VAS (Visual Analog Scale).
  5. Severity of gastrointestinal symptoms according to the GSRS (Gastrointestinal Symptom Rating Scale) questionnaire is at least 30 points.
  6. 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).
  7. Signed and dated informed consent from.

Non-inclusion Criteria:

  1. Peptic ulcer disease, duodenal ulcer, erosive GERD.
  2. Toxic megacolon.
  3. Paralytic ileus.
  4. Gilbert's syndrome.
  5. Abdominal adhesion disease.
  6. Blood in stool, unexplained weight loss, fever, anemia.
  7. Inflammatory and erosive gastrointestinal diseases.
  8. Irritable bowel syndrome, non-specific ulcerative colitis, Crohn's disease.
  9. Oncological diseases of the gastrointestinal tract (including past diagnoses).
  10. History of gastrointestinal surgical procedures, including but not limited to endoscopic papillotomy and cholecystectomy, exept for appendectomy.
  11. Use of prohibited therapy medications within 3 days prior to randomization.
  12. History of mental illnesses.
  13. Chronic heart failure IIb-III stages and/or III-IV functional classes according to NYHA, angina pectoris III-IV functional classes.
  14. Chronic kidney disease stage IIIa-V (according to NKF/KDOQI, 2006).
  15. 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.
  16. HIV, syphilis, viral hepatitis B or C, including in history.
  17. Lactose intolerance, lactase deficiency, and glucose-galactose malabsorption syndrome.
  18. Liver cirrhosis.
  19. Hypersensitivity to the active ingridient or any of the excipients of the drug 4-MUST.
  20. 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).
  21. Diabetes mellitus in a state of subcompensation and decompensation.
  22. Systemic connective tissue diseases.
  23. Autoimmune diseases.
  24. Need for surgical and/or endovascular treatment and/or necessity for hemodialysis procedures.
  25. Epilepsy or seizures of unclear etiology, including in history.
  26. Alcoholism, substance abuse or drug addiction, including in history.
  27. Uncorrected electrolyte disturbances.
  28. History of surgery within 6 month prior to screening.
  29. Women during pregnancy or lactation; women planning to become pregnant within the next 6 months.
  30. Patients who require prohibited concomitant therapy within this study framework.
  31. Participation in another clinical trial within the last 3 months prior to the screening visit date.
  32. Lack of willingness to cooperate from the patient's side.
  33. Other conditions that, in the investigator's judgement, may preclude the patient's participation in the study.

Exclusion Criteria:

  1. Incorrect enrollment of a patient in the study (failure to meet inclusion/exclusion criteria at the time of randomization).
  2. 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.
  3. Patient non-compliance (a compliant patient is defined as one who has taken at least 202 and no more than 303 tablets).
  4. Requirement for prohibited concomitant therapy.
  5. If the investigator judges that comtinued participation in the study would harm the patient.
  6. Pregnancy or the need for breastfeeding in the patient.
  7. Gross violation by the patient of the study protocol procedures outlined in the patient information sheet (PIS).
  8. Withdrawal of informed consent (patient's unwillingness to continue participation in the study).
  9. 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).
  10. 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.
  11. Any other reasons, including administrative issues, that in the investigator's judgement may interfere with subject's ability to comlete the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 4-MUST, 128 mg
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.
Drug: Placebo
Placebo tablet.
Drug: 4-MUST
128 mg of trimebutine 4-methylumbelliferyl sulfate tablet.
Other Names:
  • trimebutine 4-methylumbelliferyl sulfate
Experimental: 4-MUST, 256 mg
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.
Drug: Placebo
Placebo tablet.
Drug: 4-MUST
128 mg of trimebutine 4-methylumbelliferyl sulfate tablet.
Other Names:
  • trimebutine 4-methylumbelliferyl sulfate
Experimental: 4-MUST, 384 mg
Patients will receive 3 tablets of the drug 4-MUST (384 mg of trimebutine 4-methylumbelliferyl sulfate) three times a day.
Drug: 4-MUST
128 mg of trimebutine 4-methylumbelliferyl sulfate tablet.
Other Names:
  • trimebutine 4-methylumbelliferyl sulfate
Placebo Comparator: Placebo
Patients will receive 3 placebo tablets three times a day.
Drug: Placebo
Placebo tablet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: Day 29 ± 1
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability: adverse event (AE) rate
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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)
Time Frame: Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1
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)
Time Frame: Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1
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)
Time Frame: Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1
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)
Time Frame: Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1
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
Time Frame: Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1
Body temperature, Celsius scale
Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1
Physical examination results: cardiovascular system
Time Frame: Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1
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
Time Frame: Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1
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
Time Frame: Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1
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
Time Frame: Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1
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
Time Frame: Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1
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
Time Frame: Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1
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
Time Frame: Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1
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
Time Frame: Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1
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
Time Frame: Screening, day 15 ± 1, day 29 ± 1
Hemoglobin (g/L)
Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: clinical blood test - hematocrit
Time Frame: Screening, day 15 ± 1, day 29 ± 1
Hematocrit (%)
Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: clinical blood test - red blood cell count
Time Frame: Screening, day 15 ± 1, day 29 ± 1
Red blood cell count (cells/L)
Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: clinical blood test - platelet count
Time Frame: Screening, day 15 ± 1, day 29 ± 1
Platelet count (cells/L)
Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: clinical blood test - leukocyte count
Time Frame: Screening, day 15 ± 1, day 29 ± 1
Leukocyte count (cells/L)
Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: clinical blood test - erythrocyte sedimentation rate
Time Frame: Screening, day 15 ± 1, day 29 ± 1
Erythrocyte sedimentation rate (mm/h)
Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: clinical blood test - myelocytes
Time Frame: Screening, day 15 ± 1, day 29 ± 1
Leukocyte formula (myelocytes, %)
Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: clinical blood test - band neutrophils
Time Frame: Screening, day 15 ± 1, day 29 ± 1
Leukocyte formula (band neutrophils, %)
Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: clinical blood test - segmented neutrophils
Time Frame: Screening, day 15 ± 1, day 29 ± 1
Leukocyte formula (segmented neutrophils, %)
Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: clinical blood test - eosinophils
Time Frame: Screening, day 15 ± 1, day 29 ± 1
Leukocyte formula (eosinophils, %)
Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: clinical blood test - basophils
Time Frame: Screening, day 15 ± 1, day 29 ± 1
Leukocyte formula (basophils, %)
Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: clinical blood test - monocytes
Time Frame: Screening, day 15 ± 1, day 29 ± 1
Leukocyte formula (monocytes, %)
Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: clinical blood test - lymphocytes
Time Frame: Screening, day 15 ± 1, day 29 ± 1
Leukocyte formula (lymphocytes, %)
Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: blood chemistry - glucose
Time Frame: Screening, day 15 ± 1, day 29 ± 1
Glucose concentration (mmol/L)
Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: blood chemistry - cholesterol
Time Frame: Screening, day 15 ± 1, day 29 ± 1
Total cholesterol concentration (mmol/L)
Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: blood chemistry - protein
Time Frame: Screening, day 15 ± 1, day 29 ± 1
Total protein concentration (g/L)
Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: blood chemistry - bilirubin
Time Frame: Screening, day 15 ± 1, day 29 ± 1
Total bilirubin concentration (micromol/L)
Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: blood chemistry - creatinine
Time Frame: Screening, day 15 ± 1, day 29 ± 1
Creatinine concentration (micromol/L)
Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: blood chemistry - alkaline phosphatase
Time Frame: Screening, day 15 ± 1, day 29 ± 1
Alkaline phosphatase activity (U/L)
Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: blood chemistry - alanine transaminase
Time Frame: Screening, day 15 ± 1, day 29 ± 1
Alanine transaminase activity (U/L)
Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: blood chemistry - aspartate transaminase
Time Frame: Screening, day 15 ± 1, day 29 ± 1
Aspartate transaminase activity (U/L)
Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: blood chemistry - gamma-GTP
Time Frame: Screening, day 15 ± 1, day 29 ± 1
Gamma-glutaryl transpeptidase activity (U/L)
Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: urinalysis - specific gravity
Time Frame: Screening, day 15 ± 1, day 29 ± 1
Specific gravity of the urine
Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: urinalysis - pH
Time Frame: Screening, day 15 ± 1, day 29 ± 1
pH of the urine
Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: urinalysis - protein
Time Frame: Screening, day 15 ± 1, day 29 ± 1
Protein concentration (g/L)
Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: urinalysis - glucose
Time Frame: Screening, day 15 ± 1, day 29 ± 1
Glucose concentration (mmol/L)
Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: urinalysis - red blood cells
Time Frame: Screening, day 15 ± 1, day 29 ± 1
Red blood cell content (number in sight)
Screening, day 15 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: urinalysis - white blood cells
Time Frame: Screening, day 15 ± 1, day 29 ± 1
White blood cell content (number in sight)
Screening, day 15 ± 1, day 29 ± 1
Safety and Tolerability: 12-lead electrocardiogram (ECG) - heart rate
Time Frame: Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1
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
Time Frame: Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1
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
Time Frame: Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1
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
Time Frame: Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1
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
Change in the total score of gastrointestinal symptom severity according to the GSRS questionnaire on days 8, 15, 22, and 29 compared to baseline
Time Frame: Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
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
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
Time Frame: Day 29 ± 1
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
Time Frame: Day 29 ± 1
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
Time Frame: Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
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
Time Frame: Day 29 ± 1
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
Time Frame: Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Valenta Pharm JSC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

February 17, 2025

First Submitted That Met QC Criteria

February 17, 2025

First Posted (Actual)

February 24, 2025

Study Record Updates

Last Update Posted (Actual)

July 11, 2025

Last Update Submitted That Met QC Criteria

July 7, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIB-02-03-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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