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

12 mai 2026 mis à jour par: Valenta Pharm JSC

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

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

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

300

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Russie
      • Moscow, Russie, 119571
        • Recrutement
        • Unimed-C Jsc
        • Contact:
          • Olga Orlova, MD
          • Numéro de téléphone: +7 (919) 994-90-14
          • E-mail: orlelik@mail.ru
      • Moscow, Russie, 117556
        • Recrutement
        • State Budgetary Institution of Healthcare of Moscow "City Polyclinic No. 2 of the Moscow Department of Healthcare"
        • Contact:
      • Moscow, Russie
        • Recrutement
        • The State Budgetary Healthcare Institution of the Moscow Region "Moscow Regional Research Clinical Institute named after M.F. Vladimirsky"
        • Contact:
          • Olga Kostyukevich, MD, PhD
          • Numéro de téléphone: +7 (916) 247-22-12
          • E-mail: kostyukevich@mail.ru
      • Novosibirsk, Russie
        • Recrutement
        • Limited Liability Company "ErSi Medical"
        • Contact:
      • Perm, Russie, 614990
        • Recrutement
        • 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
        • Contact:
      • Saint Petersburg, Russie, 194358
        • Recrutement
        • St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 117"
        • Contact:
          • Diana Alpenidze, MD,PhD
          • Numéro de téléphone: +7 (911) 760-51-15
          • E-mail: d.alpenidze@mail.ru
      • Saint Petersburg, Russie, 196143
        • Recrutement
        • Limited Liability Company "Research Center Eco-Safety"
        • Contact:
      • Saint Petersburg, Russie, 196158
        • Recrutement
        • Limited Liability Company "Clinic Zvezdnaya"
        • Contact:
      • Saratov, Russie, 410071
        • Recrutement
        • State Healthcare Institution "Saratov City Clinical Hospital No. 5"
        • Contact:
          • Evgenii Orlikov, MD
          • Numéro de téléphone: +7 (906) 307-29-00
          • E-mail: eorlikov@gmail.com

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  1. Males and females aged 18-70 years.
  2. Diagnosed with chronic cholecystitis (K81.1) and/or dyskinesia of the cystic duct or gallbladder (K82.8) prior to enrollment; diagnosis supported by clinical history of exacerbations and remissions and/or imaging/laboratory findings.
  3. Upper abdominal pain or discomfort attributable to gallbladder or biliary tract dysfunction (per investigator assessment), accompanied by ≥1 of the following: heartburn, belching, nausea, abdominal bloating, borborygmi (stomach rumbling), flatulence, constipation, or diarrhea.
  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. The total bilirubin level does not exceed 2 times the upper limit of normal (no more than 42 μmol/L).
  7. 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).
  8. Signed and dated informed consent from.

Non-inclusion Criteria:

  1. Gastric or duodenal ulcer, erosive gastroesophageal reflux disease (GERD), or other inflammatory/erosive gastrointestinal diseases in the acute stage, unless stable remission for ≥ 1 year since the last exacerbation.
  2. Indication for surgical or endoscopic intervention due to exacerbation of chronic cholecystitis or complications of biliary tract dyskinesia.
  3. Toxic megacolon.
  4. Paralytic ileus.
  5. Gilbert's syndrome.
  6. Choledocholithiasis (or a high risk of its development, as determined by the investigator);
  7. Impaired bile outflow due to adhesions in the abdominal cavity.Abdominal adhesion disease.
  8. Irritable bowel syndrome, non-specific ulcerative colitis, Crohn's disease.
  9. Gastrointestinal malignancy (including history of) or suspected gastrointestinal malignancy (e.g., blood in stool, unexplained weight loss, fever, anemia).
  10. Any other oncological diseases known at the time of screening, or suspicion thereof.
  11. History of gastrointestinal surgery, including cholecystectomy or endoscopic sphincterotomy (appendectomy excluded).
  12. Use of prohibited therapy medications within 3 days prior to randomization.
  13. History of mental illnesses.
  14. Chronic heart failure IIb-III stages and/or III-IV functional classes according to NYHA, angina pectoris III-IV functional classes.
  15. Chronic kidney disease stage IIIa-V (according to NKF/KDOQI, 2006).
  16. History of or current hepatic impairment; or liver test abnormalities: AST, ALT, ALP, or GGT >3 above the upper limit of normal (ULN); total bilirubin >2 ULN or clinical jaundice.
  17. HIV, syphilis, viral hepatitis B or C, including in history.
  18. Lactose intolerance, lactase deficiency, and glucose-galactose malabsorption syndrome.
  19. Liver cirrhosis.
  20. Hypersensitivity to the active ingridient or any of the excipients of the drug 4-MUST.
  21. Severe, decompensated, or unstable somatic conditions that are life-threatening, worsen prognosis, or preclude safe study participation.
  22. Diabetes mellitus in a state of subcompensation and decompensation.
  23. Systemic connective tissue diseases.
  24. Autoimmune diseases.
  25. Indication for hemodialysis procedures.
  26. Epilepsy or seizures of unclear etiology, including in history.
  27. Alcoholism, substance abuse or drug addiction, including in history.
  28. Uncorrected electrolyte disturbances.
  29. QTcF interval on a 12-lead electrocardiogram (ECG) ≥430 ms in men and ≥450 ms in women.
  30. Episodes of constipation during the last 3 months that required the prescription of drug therapy.
  31. History of surgery within 6 month prior to screening.
  32. Women during pregnancy or lactation; women planning to become pregnant within the next 6 months.
  33. Patients who require prohibited concomitant therapy within this study framework.
  34. Participation in another clinical trial within the last 3 months prior to the screening visit date.
  35. Unwillingness or inability to comply with study procedures and protocol requirements..
  36. 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. Lack of Efficacy. Study treatment will be discontinued if no clinical improvement is observed by Visit 3 (Day 15 ± 1), defined as persistence or worsening of upper abdominal pain/discomfort (assessed by Visual Analog Scale [VAS]) compared to baseline. Upon discontinuation, alternative therapy will be initiated at the investigator's discretion.
  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. Use of Duspatalin® (INN: mebeverine) for more than 3 consecutive days or for more than 5 days in total throughout the study.
  6. If the investigator judges that comtinued participation in the study would harm the patient.
  7. Pregnancy or the need for breastfeeding.
  8. Major protocol deviation by the subject with respect to procedures outlined in the Informed Consent Form (ICF).
  9. Withdrawal of informed consent by the subject (decision to discontinue study participation).
  10. Lost to follow-up: Inability to contact the subject after ≥3 documented attempts via mobile phone, landline (if applicable), and designated emergency contact.
  11. 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.
  12. Any other reasons, including administrative issues, that in the investigator's judgement may interfere with subject's ability to comlete the study.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 4-MUST
4-MUST: 384 mg (3 tablets), orally three times a day (TID), 30 min before meals. Total daily dose - 1152 mg.
Médicament: À 4 mors
128 mg de tablette de sulfate de 4-méthylumbellifate de trimebutine.
Autres noms:
  • trimebutine 4-méthylumbellifate de sulfate
Comparateur placebo: Placebo
Placebo: 3 tablets, orally three times a day (TID), 30 min before meals.
Médicament: Placebo
Comprimé placebo.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Mean reduction in the severity of pain/discomfort in the upper abdomen on the VAS by day 29 compared to baseline
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Innocuité et tolérabilité: signes vitaux - pression artérielle systolique (SBP)
Délai: Crésage, jour 1, jour 8 ± 1, jour 15 ± 1, jour 22 ± 1, jour 29 ± 1
SBP, MMHG
Crésage, jour 1, jour 8 ± 1, jour 15 ± 1, jour 22 ± 1, jour 29 ± 1
Innocuité et tolérabilité: signes vitaux - pression artérielle diastolique (DBP)
Délai: Crésage, jour 1, jour 8 ± 1, jour 15 ± 1, jour 22 ± 1, jour 29 ± 1
DBP, MMHG
Crésage, jour 1, jour 8 ± 1, jour 15 ± 1, jour 22 ± 1, jour 29 ± 1
Innocuité et tolérabilité: signes vitaux - fréquence respiratoire (RR)
Délai: Crésage, jour 1, jour 8 ± 1, jour 15 ± 1, jour 22 ± 1, jour 29 ± 1
RR, respirations par minute
Crésage, jour 1, jour 8 ± 1, jour 15 ± 1, jour 22 ± 1, jour 29 ± 1
Sécurité et tolérabilité: signes vitaux - fréquence cardiaque (HR)
Délai: Crésage, jour 1, jour 8 ± 1, jour 15 ± 1, jour 22 ± 1, jour 29 ± 1
RH, bat par minute
Crésage, jour 1, jour 8 ± 1, jour 15 ± 1, jour 22 ± 1, jour 29 ± 1
Sécurité et tolérabilité: signes vitaux - température corporelle
Délai: Crésage, jour 1, jour 8 ± 1, jour 15 ± 1, jour 22 ± 1, jour 29 ± 1
Température corporelle, échelle Celsius
Crésage, jour 1, jour 8 ± 1, jour 15 ± 1, jour 22 ± 1, jour 29 ± 1
Résultats de l'examen physique: système cardiovasculaire
Délai: Crésage, jour 1, jour 8 ± 1, jour 15 ± 1, jour 22 ± 1, jour 29 ± 1
Une évaluation de l'état du système cardiovasculaire à l'examen physique (condition normale ou liste de conditions anormales, le cas échéant)
Crésage, jour 1, jour 8 ± 1, jour 15 ± 1, jour 22 ± 1, jour 29 ± 1
Résultats de l'examen physique: tube digestif
Délai: Crésage, jour 1, jour 8 ± 1, jour 15 ± 1, jour 22 ± 1, jour 29 ± 1
Une évaluation de l'état du tube digestif à l'examen physique (condition normale ou liste de conditions anormales, le cas échéant)
Crésage, jour 1, jour 8 ± 1, jour 15 ± 1, jour 22 ± 1, jour 29 ± 1
Résultats de l'examen physique: système endocrinien
Délai: Crésage, jour 1, jour 8 ± 1, jour 15 ± 1, jour 22 ± 1, jour 29 ± 1
Une évaluation de l'état du système endocrinien à l'examen physique (condition normale ou liste de conditions anormales, le cas échéant)
Crésage, jour 1, jour 8 ± 1, jour 15 ± 1, jour 22 ± 1, jour 29 ± 1
Résultats de l'examen physique: système musculo-squelettique
Délai: Crésage, jour 1, jour 8 ± 1, jour 15 ± 1, jour 22 ± 1, jour 29 ± 1
Une évaluation de l'état du système musculo-squelettique à l'examen physique (condition normale ou liste de conditions anormales, le cas échéant)
Crésage, jour 1, jour 8 ± 1, jour 15 ± 1, jour 22 ± 1, jour 29 ± 1
Résultats de l'examen physique: système nerveux
Délai: Crésage, jour 1, jour 8 ± 1, jour 15 ± 1, jour 22 ± 1, jour 29 ± 1
Une évaluation de l'état du système nerveux à l'examen physique (condition normale ou liste de conditions anormales, le cas échéant)
Crésage, jour 1, jour 8 ± 1, jour 15 ± 1, jour 22 ± 1, jour 29 ± 1
Résultats de l'examen physique: systèmes sensoriels
Délai: Crésage, jour 1, jour 8 ± 1, jour 15 ± 1, jour 22 ± 1, jour 29 ± 1
Une évaluation de l'état des systèmes sensoriels à l'examen physique (condition normale ou liste de conditions anormales, le cas échéant)
Crésage, jour 1, jour 8 ± 1, jour 15 ± 1, jour 22 ± 1, jour 29 ± 1
Résultats de l'examen physique: muqueuses cutanées / visibles
Délai: Crésage, jour 1, jour 8 ± 1, jour 15 ± 1, jour 22 ± 1, jour 29 ± 1
Une évaluation de l'état des muqueuses cutanées / visibles à l'examen physique (condition normale ou liste de conditions anormales, le cas échéant)
Crésage, jour 1, jour 8 ± 1, jour 15 ± 1, jour 22 ± 1, jour 29 ± 1
Résultats des examens de laboratoire et instrumentaux: test sanguin clinique - l'hémoglobine
Délai: Dépistage, jour 15 ± 1, jour 29 ± 1
Hémoglobine (g / l)
Dépistage, jour 15 ± 1, jour 29 ± 1
Résultats des examens de laboratoire et instrumentaux: test sanguin clinique - hématocrite
Délai: Dépistage, jour 15 ± 1, jour 29 ± 1
Hématocrite (%)
Dépistage, jour 15 ± 1, jour 29 ± 1
Résultats des examens de laboratoire et instrumentaux: test sanguin clinique - Nombre de globules rouges
Délai: Dépistage, jour 15 ± 1, jour 29 ± 1
Nombre de globules rouges (cellules / L)
Dépistage, jour 15 ± 1, jour 29 ± 1
Résultats des examens de laboratoire et instrumentaux: test sanguin clinique - Nombre de plaquettes
Délai: Dépistage, jour 15 ± 1, jour 29 ± 1
Nombre de plaquettes (cellules / L)
Dépistage, jour 15 ± 1, jour 29 ± 1
Résultats des examens de laboratoire et instrumentaux: test sanguin clinique - Nombre de leucocytes
Délai: Dépistage, jour 15 ± 1, jour 29 ± 1
Nombre de leucocytes (cellules / L)
Dépistage, jour 15 ± 1, jour 29 ± 1
Résultats des examens de laboratoire et instrumentaux: test sanguin clinique - taux de sédimentation des érythrocytes
Délai: Dépistage, jour 15 ± 1, jour 29 ± 1
Taux de sédimentation des érythrocytes (mm / h)
Dépistage, jour 15 ± 1, jour 29 ± 1
Résultats des examens de laboratoire et instrumentaux: test sanguin clinique - myélocytes
Délai: Dépistage, jour 15 ± 1, jour 29 ± 1
Formule de leucocytes (myélocytes,%)
Dépistage, jour 15 ± 1, jour 29 ± 1
Résultats des examens de laboratoire et instrumentaux: test sanguin clinique - Neutrophiles de bande
Délai: Dépistage, jour 15 ± 1, jour 29 ± 1
Formule de leucocytes (bande de neutrophiles,%)
Dépistage, jour 15 ± 1, jour 29 ± 1
Résultats des examens de laboratoire et instrumentaux: test sanguin clinique - neutrophiles segmentés
Délai: Dépistage, jour 15 ± 1, jour 29 ± 1
Formule de leucocytes (neutrophiles segmentés,%)
Dépistage, jour 15 ± 1, jour 29 ± 1
Résultats des examens de laboratoire et instrumentaux: test sanguin clinique - éosinophiles
Délai: Dépistage, jour 15 ± 1, jour 29 ± 1
Formule de leucocytes (éosinophiles,%)
Dépistage, jour 15 ± 1, jour 29 ± 1
Résultats des examens de laboratoire et instrumentaux: test sanguin clinique - basophiles
Délai: Dépistage, jour 15 ± 1, jour 29 ± 1
Formule de leucocytes (basophiles,%)
Dépistage, jour 15 ± 1, jour 29 ± 1
Résultats des examens de laboratoire et instrumentaux: test sanguin clinique - monocytes
Délai: Dépistage, jour 15 ± 1, jour 29 ± 1
Formule de leucocytes (monocytes,%)
Dépistage, jour 15 ± 1, jour 29 ± 1
Résultats des examens de laboratoire et instrumentaux: test sanguin clinique - lymphocytes
Délai: Dépistage, jour 15 ± 1, jour 29 ± 1
Formule de leucocytes (lymphocytes,%)
Dépistage, jour 15 ± 1, jour 29 ± 1
Résultats des examens de laboratoire et instrumentaux: chimie du sang - glucose
Délai: Dépistage, jour 15 ± 1, jour 29 ± 1
Concentration de glucose (mmol / L)
Dépistage, jour 15 ± 1, jour 29 ± 1
Résultats des examens de laboratoire et instrumentaux: chimie sanguine - cholestérol
Délai: Dépistage, jour 15 ± 1, jour 29 ± 1
Concentration totale de cholestérol (MMOL / L)
Dépistage, jour 15 ± 1, jour 29 ± 1
Résultats des examens de laboratoire et instrumentaux: chimie sanguine - protéine
Délai: Dépistage, jour 15 ± 1, jour 29 ± 1
Concentration totale de protéines (G / L)
Dépistage, jour 15 ± 1, jour 29 ± 1
Résultats des examens de laboratoire et instrumentaux: chimie du sang - bilirubine
Délai: Dépistage, jour 15 ± 1, jour 29 ± 1
Concentration totale de bilirubine (micromol / L)
Dépistage, jour 15 ± 1, jour 29 ± 1
Résultats des examens de laboratoire et instrumentaux: chimie sanguine - créatinine
Délai: Dépistage, jour 15 ± 1, jour 29 ± 1
Concentration de créatinine (micromol / L)
Dépistage, jour 15 ± 1, jour 29 ± 1
Résultats des examens de laboratoire et instrumentaux: chimie sanguine - phosphatase alcaline
Délai: Dépistage, jour 15 ± 1, jour 29 ± 1
Activité de la phosphatase alcaline (U / L)
Dépistage, jour 15 ± 1, jour 29 ± 1
Résultats des examens de laboratoire et instrumentaux: chimie sanguine - transaminase alanine
Délai: Dépistage, jour 15 ± 1, jour 29 ± 1
Activité de l'alanine transaminase (U / L)
Dépistage, jour 15 ± 1, jour 29 ± 1
Résultats des examens de laboratoire et instrumentaux: chimie du sang - Aspartate Transaminase
Délai: Dépistage, jour 15 ± 1, jour 29 ± 1
Activité de la transaminase aspartate (U / L)
Dépistage, jour 15 ± 1, jour 29 ± 1
Résultats des examens de laboratoire et instrumentaux: chimie du sang - Gamma-GTP
Délai: Dépistage, jour 15 ± 1, jour 29 ± 1
Activité de la transpeptidase gamma-glutaryl (U / L)
Dépistage, jour 15 ± 1, jour 29 ± 1
Résultats des examens de laboratoire et instrumentaux: Analyse d'urine - Gravité spécifique
Délai: Dépistage, jour 15 ± 1, jour 29 ± 1
Gravité spécifique de l'urine
Dépistage, jour 15 ± 1, jour 29 ± 1
Résultats des examens de laboratoire et instrumentaux: Analyse d'urine - PH
Délai: Dépistage, jour 15 ± 1, jour 29 ± 1
pH de l'urine
Dépistage, jour 15 ± 1, jour 29 ± 1
Résultats des examens de laboratoire et instrumentaux: Analyse d'urine - protéine
Délai: Dépistage, jour 15 ± 1, jour 29 ± 1
Concentration des protéines (g / l)
Dépistage, jour 15 ± 1, jour 29 ± 1
Résultats des examens de laboratoire et instrumentaux: Analyse d'urine - glucose
Délai: Dépistage, jour 15 ± 1, jour 29 ± 1
Concentration de glucose (mmol / L)
Dépistage, jour 15 ± 1, jour 29 ± 1
Résultats des examens de laboratoire et instrumentaux: Analyse d'urine - globules rouges
Délai: Dépistage, jour 15 ± 1, jour 29 ± 1
Contenu des globules rouges (nombre en vue)
Dépistage, jour 15 ± 1, jour 29 ± 1
Résultats des examens de laboratoire et instrumentaux: Analyse d'urine - globules blancs
Délai: Dépistage, jour 15 ± 1, jour 29 ± 1
Contenu des globules blancs (nombre en vue)
Dépistage, jour 15 ± 1, jour 29 ± 1
Mean reduction in the severity of pain/discomfort in the upper abdomen according to VAS by days 2-28 from the start of therapy
Délai: Day 2 - Day 28
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.
Délai: 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
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.
Délai: 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
Time to therapeutic response (reduction in the severity of pain/discomfort in the upper abdomen according to VAS by 30% or more)
Délai: 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
Time to therapeutic response (reduction in the severity of pain/discomfort in the upper abdomen according to VAS by 50% or more)
Délai: 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
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.
Délai: 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
Time to clinical recovery (reduction in the severity of pain/discomfort in the upper abdomen according to VAS to 10 mm or less)
Délai: 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 the total score of gastroenterological symptom severity according to the GSRS questionnaire by days 8, 15, 22, and 29 following treatment initiation.
Délai: 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 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.
Délai: 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 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.
Délai: 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 according to the total score on the SF-36 questionnaire by day 29 from treatment initiation.
Délai: 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
Change in the total score on the PAGI-SYM questionnaire by days 15 and 29 from treatment initiation.
Délai: Day 15 ± 1, and 29 ± 1
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
Délai: Day 15 ± 1, and 29 ± 1
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
Délai: Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
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
Délai: From screening (and signing informed consent form) to the end of the study (Day 36 ± 2)
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
Délai: From screening (and signing informed consent form) to the end of the study (Day 36 ± 2)
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
Délai: From screening (and signing informed consent form) to the end of the study (Day 36 ± 2)
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
Délai: From screening (and signing informed consent form) to the end of the study (Day 36 ± 2)
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
Délai: From screening (and signing informed consent form) to the end of the study (Day 36 ± 2)
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)
Physical examination results: respiratory system
Délai: 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)
Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1
Results of laboratory and instrumental examinations: blood chemistry - CRP
Délai: Screening, day 15 ± 1, day 29 ± 1
C-reactive protein, CRP (mg/L)
Screening, day 15 ± 1, day 29 ± 1
Safety and Tolerability: 12-lead electrocardiogram (ECG) - heart rate
Délai: Screening, day 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 29 ± 1
Safety and Tolerability: 12-lead electrocardiogram (ECG) - PQ interval
Délai: Screening, day 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 29 ± 1
Safety and Tolerability: 12-lead electrocardiogram (ECG) - QRS complex
Délai: Screening, day 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 29 ± 1
Safety and Tolerability: 12-lead electrocardiogram (ECG) - corrected QT interval
Délai: Screening, day 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 29 ± 1

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Valenta Pharm JSC

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

12 décembre 2025

Achèvement primaire (Estimé)

31 décembre 2027

Achèvement de l'étude (Estimé)

31 décembre 2027

Dates d'inscription aux études

Première soumission

12 mai 2026

Première soumission répondant aux critères de contrôle qualité

12 mai 2026

Première publication (Réel)

19 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

19 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 mai 2026

Dernière vérification

1 mars 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • GIB-03-04-2025

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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