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

12. maj 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

300

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 4-MUST
4-MUST: 384 mg (3 tablets), orally three times a day (TID), 30 min before meals. Total daily dose - 1152 mg.
Medicin: 4-Must
128 mg trimebutin 4-methylumbelliferylsulfattablet.
Andre navne:
  • Trimebutine 4-methylumbelliferylsulfat
Placebo komparator: Placebo
Placebo: 3 tablets, orally three times a day (TID), 30 min before meals.
Medicin: Placebo
Placebo tablet.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean reduction in the severity of pain/discomfort in the upper abdomen on the VAS by day 29 compared to baseline
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sikkerhed og tolerabilitet: Vital Signs - Systolic Blood Pressure (SBP)
Tidsramme: 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
Sikkerhed og tolerabilitet: Vital Signs - Diastolisk blodtryk (DBP)
Tidsramme: 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
Sikkerhed og tolerabilitet: Vital Signs - Respiratory Rate (RR)
Tidsramme: Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
RR, åndedræt pr. Minut
Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
Sikkerhed og tolerabilitet: Vital Signs - Hjertefrekvens (HR)
Tidsramme: Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
HR, slår pr. Minut
Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
Sikkerhed og tolerabilitet: Vital Signs - Kropstemperatur
Tidsramme: Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
Kropstemperatur, Celsius skala
Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
Resultater af fysiske undersøgelser: Kardiovaskulært system
Tidsramme: Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
En vurdering af tilstanden af ​​det kardiovaskulære system om fysisk undersøgelse (normal tilstand eller liste over unormale forhold, hvis nogen)
Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
Resultater af fysiske undersøgelser: fordøjelseskanalen
Tidsramme: Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
En vurdering af fordøjelseskanalens tilstand ved fysisk undersøgelse (normal tilstand eller liste over unormale forhold, hvis nogen)
Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
Resultater af fysiske undersøgelser: Endokrine system
Tidsramme: Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
En vurdering af det endokrine systems tilstand om fysisk undersøgelse (normal tilstand eller liste over unormale tilstande, hvis nogen)
Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
Resultater af fysiske undersøgelser: Muskuloskeletalsystem
Tidsramme: Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
En vurdering af tilstanden for muskuloskeletalsystemet om fysisk undersøgelse (normal tilstand eller liste over unormale tilstande, hvis nogen)
Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
Resultater af fysiske undersøgelser: nervesystem
Tidsramme: Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
En vurdering af nervesystemets tilstand ved fysisk undersøgelse (normal tilstand eller liste over unormale forhold, hvis nogen)
Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
Resultater af fysiske undersøgelser: Sensoriske systemer
Tidsramme: Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
En vurdering af tilstanden af ​​de sensoriske systemer om fysisk undersøgelse (normal tilstand eller liste over unormale forhold, hvis nogen)
Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
Resultater af fysiske undersøgelser: hud/synlige slimhinder
Tidsramme: Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
En vurdering af tilstanden af ​​huden/synlige slimhinderne på fysisk undersøgelse (normal tilstand eller liste over unormale forhold, hvis nogen)
Screening, dag 1, dag 8 ± 1, dag 15 ± 1, dag 22 ± 1, dag 29 ± 1
Resultater af laboratorie- og instrumentelle undersøgelser: Klinisk blodprøve - Hemoglobin
Tidsramme: Screening, dag 15 ± 1, dag 29 ± 1
Hæmoglobin (g/l)
Screening, dag 15 ± 1, dag 29 ± 1
Resultater af laboratorie- og instrumentelle undersøgelser: Klinisk blodprøve - Hematokrit
Tidsramme: Screening, dag 15 ± 1, dag 29 ± 1
Hæmatokrit (%)
Screening, dag 15 ± 1, dag 29 ± 1
Resultater af laboratorie- og instrumentelle undersøgelser: Klinisk blodprøve - Røde blodlegemer
Tidsramme: Screening, dag 15 ± 1, dag 29 ± 1
Tælling af røde blodlegemer (celler/L)
Screening, dag 15 ± 1, dag 29 ± 1
Resultater af laboratorie- og instrumentelundersøgelser: Klinisk blodprøve - Gennemførelse af blodplader
Tidsramme: Screening, dag 15 ± 1, dag 29 ± 1
Blodpladeoptælling (celler/L)
Screening, dag 15 ± 1, dag 29 ± 1
Resultater af laboratorie- og instrumentalundersøgelser: Klinisk blodprøve - Leukocytantal
Tidsramme: Screening, dag 15 ± 1, dag 29 ± 1
Leukocyttælling (celler/L)
Screening, dag 15 ± 1, dag 29 ± 1
Resultater af laboratorie- og instrumentalundersøgelser: Klinisk blodprøve - Erytrocytsedimentationshastighed
Tidsramme: Screening, dag 15 ± 1, dag 29 ± 1
Erytrocytsedimentationshastighed (mm/h)
Screening, dag 15 ± 1, dag 29 ± 1
Resultater af laboratorie- og instrumentelle undersøgelser: Klinisk blodprøve - Myelocytter
Tidsramme: Screening, dag 15 ± 1, dag 29 ± 1
Leukocytformel (myelocytter, %)
Screening, dag 15 ± 1, dag 29 ± 1
Resultater af laboratorie- og instrumentelle undersøgelser: Klinisk blodprøve - Båndneutrofiler
Tidsramme: Screening, dag 15 ± 1, dag 29 ± 1
Leukocytformel (båndneutrofiler, %)
Screening, dag 15 ± 1, dag 29 ± 1
Resultater af laboratorie- og instrumentelle undersøgelser: Klinisk blodprøve - Segmenterede neutrofiler
Tidsramme: Screening, dag 15 ± 1, dag 29 ± 1
Leukocytformel (segmenterede neutrofiler, %)
Screening, dag 15 ± 1, dag 29 ± 1
Resultater af laboratorie- og instrumentelle undersøgelser: Klinisk blodprøve - Eosinofiler
Tidsramme: Screening, dag 15 ± 1, dag 29 ± 1
Leukocytformel (Eosinophils, %)
Screening, dag 15 ± 1, dag 29 ± 1
Resultater af laboratorie- og instrumentelle undersøgelser: Klinisk blodprøve - Basofiler
Tidsramme: Screening, dag 15 ± 1, dag 29 ± 1
Leukocytformel (basofiler, %)
Screening, dag 15 ± 1, dag 29 ± 1
Resultater af laboratorie- og instrumentelle undersøgelser: Klinisk blodprøve - monocytter
Tidsramme: Screening, dag 15 ± 1, dag 29 ± 1
Leukocytformel (monocytter, %)
Screening, dag 15 ± 1, dag 29 ± 1
Resultater af laboratorie- og instrumentelle undersøgelser: Klinisk blodprøve - Lymfocytter
Tidsramme: Screening, dag 15 ± 1, dag 29 ± 1
Leukocytformel (lymfocytter, %)
Screening, dag 15 ± 1, dag 29 ± 1
Resultater af laboratorie- og instrumentalundersøgelser: Blodkemi - Glukose
Tidsramme: Screening, dag 15 ± 1, dag 29 ± 1
Glukosekoncentration (mmol/L)
Screening, dag 15 ± 1, dag 29 ± 1
Resultater af laboratorie- og instrumentelle undersøgelser: Blodkemi - kolesterol
Tidsramme: Screening, dag 15 ± 1, dag 29 ± 1
Total kolesterolkoncentration (mmol/L)
Screening, dag 15 ± 1, dag 29 ± 1
Resultater af laboratorie- og instrumentelle undersøgelser: Blodkemi - Protein
Tidsramme: Screening, dag 15 ± 1, dag 29 ± 1
Total proteinkoncentration (G/L)
Screening, dag 15 ± 1, dag 29 ± 1
Resultater af laboratorie- og instrumentelle undersøgelser: Blodkemi - Bilirubin
Tidsramme: Screening, dag 15 ± 1, dag 29 ± 1
Total Bilirubin -koncentration (Micromol/L)
Screening, dag 15 ± 1, dag 29 ± 1
Resultater af laboratorie- og instrumentelle undersøgelser: Blodkemi - Kreatinin
Tidsramme: Screening, dag 15 ± 1, dag 29 ± 1
Kreatininkoncentration (Micromol/L)
Screening, dag 15 ± 1, dag 29 ± 1
Resultater af laboratorie- og instrumentalundersøgelser: Blodkemi - Alkalisk phosphatase
Tidsramme: Screening, dag 15 ± 1, dag 29 ± 1
Alkalisk phosphatase -aktivitet (U/L)
Screening, dag 15 ± 1, dag 29 ± 1
Resultater af laboratorie- og instrumentelle undersøgelser: Blodkemi - Alanintransaminase
Tidsramme: Screening, dag 15 ± 1, dag 29 ± 1
Alanin Transaminase Activity (U/L)
Screening, dag 15 ± 1, dag 29 ± 1
Resultater af laboratorie- og instrumentalundersøgelser: Blodkemi - Aspartattransaminase
Tidsramme: Screening, dag 15 ± 1, dag 29 ± 1
Aspartattransaminaseaktivitet (U/L)
Screening, dag 15 ± 1, dag 29 ± 1
Resultater af laboratorie- og instrumentalundersøgelser: Blodkemi - Gamma -GTP
Tidsramme: Screening, dag 15 ± 1, dag 29 ± 1
Gamma-Glutaryl Transpeptidase Activity (U/L)
Screening, dag 15 ± 1, dag 29 ± 1
Resultater af laboratorie- og instrumentelle undersøgelser: Urinalyse - Specifik tyngdekraft
Tidsramme: Screening, dag 15 ± 1, dag 29 ± 1
Specifik tyngdekraft af urinen
Screening, dag 15 ± 1, dag 29 ± 1
Resultater af laboratorie- og instrumentelle undersøgelser: Urinalyse - PH
Tidsramme: Screening, dag 15 ± 1, dag 29 ± 1
pH i urinen
Screening, dag 15 ± 1, dag 29 ± 1
Resultater af laboratorie- og instrumentelle undersøgelser: Urinalyse - Protein
Tidsramme: Screening, dag 15 ± 1, dag 29 ± 1
Proteinkoncentration (G/L)
Screening, dag 15 ± 1, dag 29 ± 1
Resultater af laboratorie- og instrumentalundersøgelser: Urinalyse - Glukose
Tidsramme: Screening, dag 15 ± 1, dag 29 ± 1
Glukosekoncentration (mmol/L)
Screening, dag 15 ± 1, dag 29 ± 1
Resultater af laboratorie- og instrumentelle undersøgelser: Urinalyse - Røde blodlegemer
Tidsramme: Screening, dag 15 ± 1, dag 29 ± 1
Indhold i røde blodlegemer (nummer i syne)
Screening, dag 15 ± 1, dag 29 ± 1
Resultater af laboratorie- og instrumentelle undersøgelser: Urinalyse - Hvide blodlegemer
Tidsramme: Screening, dag 15 ± 1, dag 29 ± 1
Hvide blodlegemer indhold (nummer i syne)
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
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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.
Tidsramme: 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)
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

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Sponsor

Valenta Pharm JSC

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

12. december 2025

Primær færdiggørelse (Anslået)

31. december 2027

Studieafslutning (Anslået)

31. december 2027

Datoer for studieregistrering

Først indsendt

12. maj 2026

Først indsendt, der opfyldte QC-kriterier

12. maj 2026

Først opslået (Faktiske)

19. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. maj 2026

Sidst verificeret

1. marts 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GIB-03-04-2025

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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