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

12 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

300

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Rusland
      • Moscow, Rusland, 119571
        • Werving
        • Unimed-C Jsc
        • Contact:
          • Olga Orlova, MD
          • Telefoonnummer: +7 (919) 994-90-14
          • E-mail: orlelik@mail.ru
      • Moscow, Rusland, 117556
        • Werving
        • State Budgetary Institution of Healthcare of Moscow "City Polyclinic No. 2 of the Moscow Department of Healthcare"
        • Contact:
      • Moscow, Rusland
        • Werving
        • The State Budgetary Healthcare Institution of the Moscow Region "Moscow Regional Research Clinical Institute named after M.F. Vladimirsky"
        • Contact:
      • Novosibirsk, Rusland
        • Werving
        • Limited Liability Company "ErSi Medical"
        • Contact:
      • Perm, Rusland, 614990
        • Werving
        • 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, Rusland, 194358
        • Werving
        • St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 117"
        • Contact:
      • Saint Petersburg, Rusland, 196143
        • Werving
        • Limited Liability Company "Research Center Eco-Safety"
        • Contact:
      • Saint Petersburg, Rusland, 196158
        • Werving
        • Limited Liability Company "Clinic Zvezdnaya"
        • Contact:
      • Saratov, Rusland, 410071
        • Werving
        • State Healthcare Institution "Saratov City Clinical Hospital No. 5"
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 4-MUST
4-MUST: 384 mg (3 tablets), orally three times a day (TID), 30 min before meals. Total daily dose - 1152 mg.
Geneesmiddel: 4-must
128 mg Trimebutine 4-methylumbelliferylsulfaattablet.
Andere namen:
  • Trimebutine 4-methylumbelliferylsulfaat
Placebo-vergelijker: Placebo
Placebo: 3 tablets, orally three times a day (TID), 30 min before meals.
Geneesmiddel: Placebo
Placebo-tablet.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mean reduction in the severity of pain/discomfort in the upper abdomen on the VAS by day 29 compared to baseline
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Veiligheid en verdraagbaarheid: vitale tekenen - Systolische bloeddruk (SBP)
Tijdsspanne: Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
SBP, MMHG
Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
Veiligheid en verdraagbaarheid: vitale tekenen - Diastolische bloeddruk (DBP)
Tijdsspanne: Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
DBP, MMHG
Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
Veiligheid en verdraagbaarheid: vitale tekenen - ademhalingssnelheid (RR)
Tijdsspanne: Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
RR, ademt per minuut
Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
Veiligheid en verdraagbaarheid: vitale tekenen - hartslag (HR)
Tijdsspanne: Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
HR, beats per minuut
Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
Veiligheid en verdraagbaarheid: vitale tekenen - lichaamstemperatuur
Tijdsspanne: Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
Lichaamstemperatuur, Celsius -schaal
Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
Resultaten voor lichamelijk onderzoek: cardiovasculair systeem
Tijdsspanne: Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
Een beoordeling van de toestand van het cardiovasculaire systeem bij lichamelijk onderzoek (normale toestand of lijst van eventuele abnormale omstandigheden)
Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
Resultaten voor lichamelijk onderzoek: spijsverteringskanaal
Tijdsspanne: Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
Een beoordeling van de toestand van het spijsverteringskanaal bij lichamelijk onderzoek (normale toestand of lijst van eventuele abnormale omstandigheden)
Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
Resultaten voor lichamelijk onderzoek: endocrien systeem
Tijdsspanne: Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
Een beoordeling van de toestand van het endocriene systeem bij lichamelijk onderzoek (normale toestand of lijst met abnormale omstandigheden, indien aanwezig)
Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
Resultaten voor lichamelijk onderzoek: musculoskeletaal systeem
Tijdsspanne: Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
Een beoordeling van de toestand van het musculoskeletale systeem bij lichamelijk onderzoek (normale toestand of lijst met abnormale omstandigheden, indien van toepassing)
Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
Lichamelijk onderzoeksresultaten: zenuwstelsel
Tijdsspanne: Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
Een beoordeling van de toestand van het zenuwstelsel bij lichamelijk onderzoek (normale toestand of lijst met abnormale omstandigheden, indien van toepassing)
Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
Resultaten voor lichamelijk onderzoek: sensorische systemen
Tijdsspanne: Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
Een beoordeling van de toestand van de sensorische systemen bij lichamelijk onderzoek (normale toestand of lijst met abnormale omstandigheden, indien van toepassing)
Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
Resultaten voor lichamelijk onderzoek: huid/zichtbare slijmvliezen
Tijdsspanne: Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
Een beoordeling van de toestand van de huid/zichtbare slijmvliezen bij lichamelijk onderzoek (normale toestand of lijst met abnormale omstandigheden, indien van toepassing)
Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
Resultaten van laboratorium- en instrumentele onderzoeken: klinische bloedtest - Hemoglobine
Tijdsspanne: Screening, dag 15 ± 1, dag 29 ± 1
Hemoglobine (G/L)
Screening, dag 15 ± 1, dag 29 ± 1
Resultaten van laboratorium- en instrumentele onderzoeken: klinische bloedtest - Hematocriet
Tijdsspanne: Screening, dag 15 ± 1, dag 29 ± 1
Hematocriet (%)
Screening, dag 15 ± 1, dag 29 ± 1
Resultaten van laboratorium- en instrumentele onderzoeken: klinische bloedtest - Rode bloedcellen
Tijdsspanne: Screening, dag 15 ± 1, dag 29 ± 1
Rode bloedcellen (cellen/L)
Screening, dag 15 ± 1, dag 29 ± 1
Resultaten van laboratorium- en instrumentele onderzoeken: klinische bloedtest - Cijfers van bloedplaatjes
Tijdsspanne: Screening, dag 15 ± 1, dag 29 ± 1
Ploedplaatjestelling (cellen/L)
Screening, dag 15 ± 1, dag 29 ± 1
Resultaten van laboratorium- en instrumentele onderzoeken: klinische bloedtest - Leukocytentelling
Tijdsspanne: Screening, dag 15 ± 1, dag 29 ± 1
Leukocytentelling (cellen/L)
Screening, dag 15 ± 1, dag 29 ± 1
Resultaten van laboratorium- en instrumentele onderzoeken: klinische bloedtest - erytrocyten sedimentatiesnelheid
Tijdsspanne: Screening, dag 15 ± 1, dag 29 ± 1
Erytrocyten sedimentatiesnelheid (mm/u)
Screening, dag 15 ± 1, dag 29 ± 1
Resultaten van laboratorium- en instrumentele onderzoeken: klinische bloedtest - myelocyten
Tijdsspanne: Screening, dag 15 ± 1, dag 29 ± 1
Leukocytenformule (myelocyten, %)
Screening, dag 15 ± 1, dag 29 ± 1
Resultaten van laboratorium- en instrumentele onderzoeken: klinische bloedtest - bandneutrofielen
Tijdsspanne: Screening, dag 15 ± 1, dag 29 ± 1
Leukocytenformule (bandneutrofielen, %)
Screening, dag 15 ± 1, dag 29 ± 1
Resultaten van laboratorium- en instrumentele onderzoeken: klinische bloedtest - gesegmenteerde neutrofielen
Tijdsspanne: Screening, dag 15 ± 1, dag 29 ± 1
Leukocytenformule (gesegmenteerde neutrofielen, %)
Screening, dag 15 ± 1, dag 29 ± 1
Resultaten van laboratorium- en instrumentele onderzoeken: klinische bloedtest - eosinofielen
Tijdsspanne: Screening, dag 15 ± 1, dag 29 ± 1
Leukocytenformule (eosinofielen, %)
Screening, dag 15 ± 1, dag 29 ± 1
Resultaten van laboratorium- en instrumentele onderzoeken: klinische bloedtest - Basofils
Tijdsspanne: Screening, dag 15 ± 1, dag 29 ± 1
Leukocytenformule (basofielen, %)
Screening, dag 15 ± 1, dag 29 ± 1
Resultaten van laboratorium- en instrumentele onderzoeken: klinische bloedtest - monocyten
Tijdsspanne: Screening, dag 15 ± 1, dag 29 ± 1
Leukocytenformule (monocyten, %)
Screening, dag 15 ± 1, dag 29 ± 1
Resultaten van laboratorium- en instrumentele onderzoeken: klinische bloedtest - lymfocyten
Tijdsspanne: Screening, dag 15 ± 1, dag 29 ± 1
Leukocytenformule (lymfocyten, %)
Screening, dag 15 ± 1, dag 29 ± 1
Resultaten van laboratorium- en instrumentele onderzoeken: bloedchemie - glucose
Tijdsspanne: Screening, dag 15 ± 1, dag 29 ± 1
Glucoseconcentratie (mmol/L)
Screening, dag 15 ± 1, dag 29 ± 1
Resultaten van laboratorium- en instrumentele onderzoeken: bloedchemie - cholesterol
Tijdsspanne: Screening, dag 15 ± 1, dag 29 ± 1
Totale cholesterolconcentratie (mmol/L)
Screening, dag 15 ± 1, dag 29 ± 1
Resultaten van laboratorium- en instrumentele onderzoeken: bloedchemie - eiwit
Tijdsspanne: Screening, dag 15 ± 1, dag 29 ± 1
Totale eiwitconcentratie (G/L)
Screening, dag 15 ± 1, dag 29 ± 1
Resultaten van laboratorium- en instrumentele onderzoeken: bloedchemie - bilirubine
Tijdsspanne: Screening, dag 15 ± 1, dag 29 ± 1
Totale bilirubineconcentratie (micromol/L)
Screening, dag 15 ± 1, dag 29 ± 1
Resultaten van laboratorium- en instrumentele onderzoeken: bloedchemie - creatinine
Tijdsspanne: Screening, dag 15 ± 1, dag 29 ± 1
Creatinineconcentratie (Micromol/L)
Screening, dag 15 ± 1, dag 29 ± 1
Resultaten van laboratorium- en instrumentele onderzoeken: bloedchemie - alkalische fosfatase
Tijdsspanne: Screening, dag 15 ± 1, dag 29 ± 1
Alkalische fosfatase -activiteit (U/L)
Screening, dag 15 ± 1, dag 29 ± 1
Resultaten van laboratorium- en instrumentele onderzoeken: bloedchemie - Alanine -transaminase
Tijdsspanne: Screening, dag 15 ± 1, dag 29 ± 1
Alanine -transaminase -activiteit (U/L)
Screening, dag 15 ± 1, dag 29 ± 1
Resultaten van laboratorium- en instrumentele onderzoeken: bloedchemie - aspartaattransaminase
Tijdsspanne: Screening, dag 15 ± 1, dag 29 ± 1
Aspartaat transaminase -activiteit (U/L)
Screening, dag 15 ± 1, dag 29 ± 1
Resultaten van laboratorium- en instrumentele onderzoeken: bloedchemie - Gamma -GTP
Tijdsspanne: Screening, dag 15 ± 1, dag 29 ± 1
Gamma-glutaryl transpeptidase-activiteit (U/L)
Screening, dag 15 ± 1, dag 29 ± 1
Resultaten van laboratorium- en instrumentele onderzoeken: urineonderzoek - soortelijk gewicht
Tijdsspanne: Screening, dag 15 ± 1, dag 29 ± 1
Soortelijk gewicht van de urine
Screening, dag 15 ± 1, dag 29 ± 1
Resultaten van laboratorium- en instrumentele onderzoeken: urineonderzoek - pH
Tijdsspanne: Screening, dag 15 ± 1, dag 29 ± 1
pH van de urine
Screening, dag 15 ± 1, dag 29 ± 1
Resultaten van laboratorium- en instrumentele onderzoeken: urineonderzoek - eiwit
Tijdsspanne: Screening, dag 15 ± 1, dag 29 ± 1
Eiwitconcentratie (g/l)
Screening, dag 15 ± 1, dag 29 ± 1
Resultaten van laboratorium- en instrumentele onderzoeken: urineonderzoek - glucose
Tijdsspanne: Screening, dag 15 ± 1, dag 29 ± 1
Glucoseconcentratie (mmol/L)
Screening, dag 15 ± 1, dag 29 ± 1
Resultaten van laboratorium- en instrumentele onderzoeken: urineonderzoek - rode bloedcellen
Tijdsspanne: Screening, dag 15 ± 1, dag 29 ± 1
Rode bloedcelgehalte (nummer in zicht)
Screening, dag 15 ± 1, dag 29 ± 1
Resultaten van laboratorium- en instrumentele onderzoeken: urineonderzoek - witte bloedcellen
Tijdsspanne: Screening, dag 15 ± 1, dag 29 ± 1
White bloedcelgehalte (nummer in zicht)
Screening, dag 15 ± 1, dag 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
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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.
Tijdsspanne: 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)
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

12 december 2025

Primaire voltooiing (Geschat)

31 december 2027

Studie voltooiing (Geschat)

31 december 2027

Studieregistratiedata

Eerst ingediend

12 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

12 mei 2026

Eerst geplaatst (Werkelijk)

19 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

19 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

12 mei 2026

Laatst geverifieerd

1 maart 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • GIB-03-04-2025

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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