Efficacy, Safety, and Tolerability of 4-MUST, 128 mg Tablets in Chronic Cholecystitis and Biliary Dyskinesia
12 de maio de 2026 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
300
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Moscow, Rússia, 119571
- Recrutamento
- Unimed-C Jsc
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Contato:
- Olga Orlova, MD
- Número de telefone: +7 (919) 994-90-14
- E-mail: orlelik@mail.ru
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Moscow, Rússia, 117556
- Recrutamento
- State Budgetary Institution of Healthcare of Moscow "City Polyclinic No. 2 of the Moscow Department of Healthcare"
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Contato:
- Margarita Dorofeeva, MD, PhD
- Número de telefone: +7 (916) 128-99-78
- E-mail: margaritadorofeeva@yandex.ru
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Moscow, Rússia
- Recrutamento
- The State Budgetary Healthcare Institution of the Moscow Region "Moscow Regional Research Clinical Institute named after M.F. Vladimirsky"
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Contato:
- Olga Kostyukevich, MD, PhD
- Número de telefone: +7 (916) 247-22-12
- E-mail: kostyukevich@mail.ru
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Novosibirsk, Rússia
- Recrutamento
- Limited Liability Company "ErSi Medical"
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Contato:
- Anna Kosheleva, MD
- Número de telefone: +7-913-470-70-67
- E-mail: annkosheleva86@gmail.com
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Perm, Rússia, 614990
- Recrutamento
- 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
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Contato:
- Natalia Osokina, MD, PhD
- Número de telefone: +7 (950) 460-96-74
- E-mail: kiselevanatalya8@mail.ru
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Saint Petersburg, Rússia, 194358
- Recrutamento
- St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 117"
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Contato:
- Diana Alpenidze, MD,PhD
- Número de telefone: +7 (911) 760-51-15
- E-mail: d.alpenidze@mail.ru
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Saint Petersburg, Rússia, 196143
- Recrutamento
- Limited Liability Company "Research Center Eco-Safety"
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Contato:
- Vasiliy Vasilyuk, MD, PhD
- Número de telefone: +7 (901) 304 4248
- E-mail: vasilyuk_vb@ecosafety.ru
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Saint Petersburg, Rússia, 196158
- Recrutamento
- Limited Liability Company "Clinic Zvezdnaya"
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Contato:
- Dmitry Shkarbul, MD
- Número de telefone: +7 (911) 218-10-55
- E-mail: director@starsclinic.ru
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Saratov, Rússia, 410071
- Recrutamento
- State Healthcare Institution "Saratov City Clinical Hospital No. 5"
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Contato:
- Evgenii Orlikov, MD
- Número de telefone: +7 (906) 307-29-00
- E-mail: eorlikov@gmail.com
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- Males and females aged 18-70 years.
- 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.
- 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.
- Maximum severity of pain/discomfort in the upper abdomen over the past week is 40 mm or more on the VAS (Visual Analog Scale).
- Severity of gastrointestinal symptoms according to the GSRS (Gastrointestinal Symptom Rating Scale) questionnaire is at least 30 points.
- The total bilirubin level does not exceed 2 times the upper limit of normal (no more than 42 μmol/L).
- 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).
- Signed and dated informed consent from.
Non-inclusion Criteria:
- 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.
- Indication for surgical or endoscopic intervention due to exacerbation of chronic cholecystitis or complications of biliary tract dyskinesia.
- Toxic megacolon.
- Paralytic ileus.
- Gilbert's syndrome.
- Choledocholithiasis (or a high risk of its development, as determined by the investigator);
- Impaired bile outflow due to adhesions in the abdominal cavity.Abdominal adhesion disease.
- Irritable bowel syndrome, non-specific ulcerative colitis, Crohn's disease.
- Gastrointestinal malignancy (including history of) or suspected gastrointestinal malignancy (e.g., blood in stool, unexplained weight loss, fever, anemia).
- Any other oncological diseases known at the time of screening, or suspicion thereof.
- History of gastrointestinal surgery, including cholecystectomy or endoscopic sphincterotomy (appendectomy excluded).
- Use of prohibited therapy medications within 3 days prior to randomization.
- History of mental illnesses.
- Chronic heart failure IIb-III stages and/or III-IV functional classes according to NYHA, angina pectoris III-IV functional classes.
- Chronic kidney disease stage IIIa-V (according to NKF/KDOQI, 2006).
- 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.
- HIV, syphilis, viral hepatitis B or C, including in history.
- Lactose intolerance, lactase deficiency, and glucose-galactose malabsorption syndrome.
- Liver cirrhosis.
- Hypersensitivity to the active ingridient or any of the excipients of the drug 4-MUST.
- Severe, decompensated, or unstable somatic conditions that are life-threatening, worsen prognosis, or preclude safe study participation.
- Diabetes mellitus in a state of subcompensation and decompensation.
- Systemic connective tissue diseases.
- Autoimmune diseases.
- Indication for hemodialysis procedures.
- Epilepsy or seizures of unclear etiology, including in history.
- Alcoholism, substance abuse or drug addiction, including in history.
- Uncorrected electrolyte disturbances.
- QTcF interval on a 12-lead electrocardiogram (ECG) ≥430 ms in men and ≥450 ms in women.
- Episodes of constipation during the last 3 months that required the prescription of drug therapy.
- History of surgery within 6 month prior to screening.
- Women during pregnancy or lactation; women planning to become pregnant within the next 6 months.
- Patients who require prohibited concomitant therapy within this study framework.
- Participation in another clinical trial within the last 3 months prior to the screening visit date.
- Unwillingness or inability to comply with study procedures and protocol requirements..
- Other conditions that, in the investigator's judgement, may preclude the patient's participation in the study.
Exclusion Criteria:
- Incorrect enrollment of a patient in the study (failure to meet inclusion/exclusion criteria at the time of randomization).
- 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.
- Patient non-compliance (a compliant patient is defined as one who has taken at least 202 and no more than 303 tablets).
- Requirement for prohibited concomitant therapy.
- Use of Duspatalin® (INN: mebeverine) for more than 3 consecutive days or for more than 5 days in total throughout the study.
- If the investigator judges that comtinued participation in the study would harm the patient.
- Pregnancy or the need for breastfeeding.
- Major protocol deviation by the subject with respect to procedures outlined in the Informed Consent Form (ICF).
- Withdrawal of informed consent by the subject (decision to discontinue study participation).
- Lost to follow-up: Inability to contact the subject after ≥3 documented attempts via mobile phone, landline (if applicable), and designated emergency contact.
- 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.
- Any other reasons, including administrative issues, that in the investigator's judgement may interfere with subject's ability to comlete the study.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 4-MUST
4-MUST: 384 mg (3 tablets), orally three times a day (TID), 30 min before meals.
Total daily dose - 1152 mg.
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128 mg de comprimido de sulfato de trimebutina 4-metilumbeliferil.
Outros nomes:
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Comparador de Placebo: Placebo
Placebo: 3 tablets, orally three times a day (TID), 30 min before meals.
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Comprimido placebo.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Mean reduction in the severity of pain/discomfort in the upper abdomen on the VAS by day 29 compared to baseline
Prazo: Day 29 ± 1
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Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"
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Day 29 ± 1
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Segurança e tolerabilidade: sinais vitais - pressão arterial sistólica (SBP)
Prazo: Triagem, dia 1, dia 8 ± 1, dia 15 ± 1, dia 22 ± 1, dia 29 ± 1
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SBP, Mmhg
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Triagem, dia 1, dia 8 ± 1, dia 15 ± 1, dia 22 ± 1, dia 29 ± 1
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Segurança e tolerabilidade: sinais vitais - pressão arterial diastólica (DBP)
Prazo: Triagem, dia 1, dia 8 ± 1, dia 15 ± 1, dia 22 ± 1, dia 29 ± 1
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DBP, MMHG
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Triagem, dia 1, dia 8 ± 1, dia 15 ± 1, dia 22 ± 1, dia 29 ± 1
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Segurança e tolerabilidade: sinais vitais - frequência respiratória (RR)
Prazo: Triagem, dia 1, dia 8 ± 1, dia 15 ± 1, dia 22 ± 1, dia 29 ± 1
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RR, respirações por minuto
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Triagem, dia 1, dia 8 ± 1, dia 15 ± 1, dia 22 ± 1, dia 29 ± 1
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Segurança e tolerabilidade: sinais vitais - freqüência cardíaca (FC)
Prazo: Triagem, dia 1, dia 8 ± 1, dia 15 ± 1, dia 22 ± 1, dia 29 ± 1
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RH, batidas por minuto
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Triagem, dia 1, dia 8 ± 1, dia 15 ± 1, dia 22 ± 1, dia 29 ± 1
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Segurança e tolerabilidade: sinais vitais - temperatura corporal
Prazo: Triagem, dia 1, dia 8 ± 1, dia 15 ± 1, dia 22 ± 1, dia 29 ± 1
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Temperatura corporal, escala Celsius
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Triagem, dia 1, dia 8 ± 1, dia 15 ± 1, dia 22 ± 1, dia 29 ± 1
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Resultados do exame físico: sistema cardiovascular
Prazo: Triagem, dia 1, dia 8 ± 1, dia 15 ± 1, dia 22 ± 1, dia 29 ± 1
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Uma avaliação da condição do sistema cardiovascular no exame físico (condição normal ou lista de condições anormais, se houver)
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Triagem, dia 1, dia 8 ± 1, dia 15 ± 1, dia 22 ± 1, dia 29 ± 1
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Resultados do exame físico: trato digestivo
Prazo: Triagem, dia 1, dia 8 ± 1, dia 15 ± 1, dia 22 ± 1, dia 29 ± 1
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Uma avaliação da condição do trato digestivo no exame físico (condição normal ou lista de condições anormais, se houver)
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Triagem, dia 1, dia 8 ± 1, dia 15 ± 1, dia 22 ± 1, dia 29 ± 1
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Resultados do exame físico: sistema endócrino
Prazo: Triagem, dia 1, dia 8 ± 1, dia 15 ± 1, dia 22 ± 1, dia 29 ± 1
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Uma avaliação da condição do sistema endócrino no exame físico (condição normal ou lista de condições anormais, se houver)
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Triagem, dia 1, dia 8 ± 1, dia 15 ± 1, dia 22 ± 1, dia 29 ± 1
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Resultados do exame físico: sistema musculoesquelético
Prazo: Triagem, dia 1, dia 8 ± 1, dia 15 ± 1, dia 22 ± 1, dia 29 ± 1
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Uma avaliação da condição do sistema musculoesquelético no exame físico (condição normal ou lista de condições anormais, se houver)
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Triagem, dia 1, dia 8 ± 1, dia 15 ± 1, dia 22 ± 1, dia 29 ± 1
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Resultados do exame físico: sistema nervoso
Prazo: Triagem, dia 1, dia 8 ± 1, dia 15 ± 1, dia 22 ± 1, dia 29 ± 1
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Uma avaliação da condição do sistema nervoso no exame físico (condição normal ou lista de condições anormais, se houver)
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Triagem, dia 1, dia 8 ± 1, dia 15 ± 1, dia 22 ± 1, dia 29 ± 1
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Resultados do exame físico: sistemas sensoriais
Prazo: Triagem, dia 1, dia 8 ± 1, dia 15 ± 1, dia 22 ± 1, dia 29 ± 1
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Uma avaliação da condição dos sistemas sensoriais no exame físico (condição normal ou lista de condições anormais, se houver)
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Triagem, dia 1, dia 8 ± 1, dia 15 ± 1, dia 22 ± 1, dia 29 ± 1
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Resultados do exame físico: membranas mucosas de pele/visível
Prazo: Triagem, dia 1, dia 8 ± 1, dia 15 ± 1, dia 22 ± 1, dia 29 ± 1
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Uma avaliação da condição das membranas mucosas da pele/visível no exame físico (condição normal ou lista de condições anormais, se houver)
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Triagem, dia 1, dia 8 ± 1, dia 15 ± 1, dia 22 ± 1, dia 29 ± 1
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Resultados de exames laboratoriais e instrumentais: Exame de sangue clínico - Hemoglobina
Prazo: Triagem, dia 15 ± 1, dia 29 ± 1
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Hemoglobina (G/L)
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Triagem, dia 15 ± 1, dia 29 ± 1
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Resultados de exames laboratoriais e instrumentais: Exame de sangue clínico - Hematócrito
Prazo: Triagem, dia 15 ± 1, dia 29 ± 1
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Hematócrito (%)
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Triagem, dia 15 ± 1, dia 29 ± 1
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Resultados de exames laboratoriais e instrumentais: Exame clínico de sangue - contagem de glóbulos vermelhos
Prazo: Triagem, dia 15 ± 1, dia 29 ± 1
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Contagem de glóbulos vermelhos (células/L)
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Triagem, dia 15 ± 1, dia 29 ± 1
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Resultados de exames laboratoriais e instrumentais: Exame de sangue clínico - contagem de plaquetas
Prazo: Triagem, dia 15 ± 1, dia 29 ± 1
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Contagem de plaquetas (células/L)
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Triagem, dia 15 ± 1, dia 29 ± 1
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Resultados de exames laboratoriais e instrumentais: Exame de sangue clínico - contagem de leucócitos
Prazo: Triagem, dia 15 ± 1, dia 29 ± 1
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Contagem de leucócitos (células/L)
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Triagem, dia 15 ± 1, dia 29 ± 1
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Resultados de exames laboratoriais e instrumentais: exame de sangue clínico - taxa de sedimentação de eritrócitos
Prazo: Triagem, dia 15 ± 1, dia 29 ± 1
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Taxa de sedimentação de eritrócitos (mm/h)
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Triagem, dia 15 ± 1, dia 29 ± 1
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Resultados de exames de laboratório e instrumental: exame de sangue clínico - mielócitos
Prazo: Triagem, dia 15 ± 1, dia 29 ± 1
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Fórmula de leucócitos (mielócitos, %)
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Triagem, dia 15 ± 1, dia 29 ± 1
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Resultados de exames de laboratório e instrumental: Exame de sangue clínico - neutrófilos de banda
Prazo: Triagem, dia 15 ± 1, dia 29 ± 1
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Fórmula de leucócitos (neutrófilos da banda, %)
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Triagem, dia 15 ± 1, dia 29 ± 1
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Resultados de exames de laboratório e instrumental: Exame de sangue clínico - neutrófilos segmentados
Prazo: Triagem, dia 15 ± 1, dia 29 ± 1
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Fórmula de leucócitos (neutrófilos segmentados, %)
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Triagem, dia 15 ± 1, dia 29 ± 1
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Resultados de exames de laboratório e instrumental: exame de sangue clínico - eosinófilos
Prazo: Triagem, dia 15 ± 1, dia 29 ± 1
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Fórmula de leucócitos (eosinófilos, %)
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Triagem, dia 15 ± 1, dia 29 ± 1
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Resultados de exames de laboratório e instrumental: Exame de sangue clínico - Basófilos
Prazo: Triagem, dia 15 ± 1, dia 29 ± 1
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Fórmula de leucócitos (Basófilos, %)
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Triagem, dia 15 ± 1, dia 29 ± 1
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Resultados de exames de laboratório e instrumental: Exame de sangue clínico - Monócitos
Prazo: Triagem, dia 15 ± 1, dia 29 ± 1
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Fórmula de leucócitos (monócitos, %)
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Triagem, dia 15 ± 1, dia 29 ± 1
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Resultados de exames de laboratório e instrumental: exame de sangue clínico - linfócitos
Prazo: Triagem, dia 15 ± 1, dia 29 ± 1
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Fórmula de leucócitos (linfócitos, %)
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Triagem, dia 15 ± 1, dia 29 ± 1
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Resultados de exames laboratoriais e instrumentais: química de sangue - glicose
Prazo: Triagem, dia 15 ± 1, dia 29 ± 1
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Concentração de glicose (mmol/l)
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Triagem, dia 15 ± 1, dia 29 ± 1
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Resultados de exames laboratoriais e instrumentais: Química de Sangue - Colesterol
Prazo: Triagem, dia 15 ± 1, dia 29 ± 1
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Concentração total de colesterol (mmol/l)
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Triagem, dia 15 ± 1, dia 29 ± 1
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Resultados de exames laboratoriais e instrumentais: Química de Sangue - Proteína
Prazo: Triagem, dia 15 ± 1, dia 29 ± 1
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Concentração total de proteínas (G/L)
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Triagem, dia 15 ± 1, dia 29 ± 1
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Resultados de exames de laboratório e instrumental: Química de Sangue - Bilirrubina
Prazo: Triagem, dia 15 ± 1, dia 29 ± 1
|
Concentração total da bilirrubina (Micromol/L)
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Triagem, dia 15 ± 1, dia 29 ± 1
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Resultados de exames laboratoriais e instrumentais: Química de Sangue - Creatinina
Prazo: Triagem, dia 15 ± 1, dia 29 ± 1
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Concentração de creatinina (micromol/l)
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Triagem, dia 15 ± 1, dia 29 ± 1
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Resultados de exames laboratoriais e instrumentais: química do sangue - fosfatase alcalina
Prazo: Triagem, dia 15 ± 1, dia 29 ± 1
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Atividade alcalina fosfatase (U/L)
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Triagem, dia 15 ± 1, dia 29 ± 1
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Resultados de exames laboratoriais e instrumentais: Química de Sangue - Alanina Transaminase
Prazo: Triagem, dia 15 ± 1, dia 29 ± 1
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Atividade da transaminase de alanina (U/L)
|
Triagem, dia 15 ± 1, dia 29 ± 1
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Resultados de exames laboratoriais e instrumentais: Química de Sangue - Aspartato Transaminase
Prazo: Triagem, dia 15 ± 1, dia 29 ± 1
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Atividade da transaminase da aspartato (U/L)
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Triagem, dia 15 ± 1, dia 29 ± 1
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Resultados de exames de laboratório e instrumental: Química de Sangue - Gama -GTP
Prazo: Triagem, dia 15 ± 1, dia 29 ± 1
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Atividade de transpeptidase gama-glutaril (U/L)
|
Triagem, dia 15 ± 1, dia 29 ± 1
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Resultados de exames laboratoriais e instrumentais: Execução de urina - gravidade específica
Prazo: Triagem, dia 15 ± 1, dia 29 ± 1
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Gravidade específica da urina
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Triagem, dia 15 ± 1, dia 29 ± 1
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Resultados de exames laboratoriais e instrumentais: Urinalysis - pH
Prazo: Triagem, dia 15 ± 1, dia 29 ± 1
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ph da urina
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Triagem, dia 15 ± 1, dia 29 ± 1
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Resultados de exames laboratoriais e instrumentais: Urinalysis - proteína
Prazo: Triagem, dia 15 ± 1, dia 29 ± 1
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Concentração de proteínas (G/L)
|
Triagem, dia 15 ± 1, dia 29 ± 1
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Resultados de exames laboratoriais e instrumentais: Urinalysis - glicose
Prazo: Triagem, dia 15 ± 1, dia 29 ± 1
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Concentração de glicose (mmol/l)
|
Triagem, dia 15 ± 1, dia 29 ± 1
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Resultados de exames laboratoriais e instrumentais: Urinalysis - glóbulos vermelhos
Prazo: Triagem, dia 15 ± 1, dia 29 ± 1
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Conteúdo de glóbulos vermelhos (número à vista)
|
Triagem, dia 15 ± 1, dia 29 ± 1
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Resultados de exames laboratoriais e instrumentais: Urinalysis - glóbulos brancos
Prazo: Triagem, dia 15 ± 1, dia 29 ± 1
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Conteúdo de glóbulos brancos (número à vista)
|
Triagem, dia 15 ± 1, dia 29 ± 1
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Mean reduction in the severity of pain/discomfort in the upper abdomen according to VAS by days 2-28 from the start of therapy
Prazo: Day 2 - Day 28
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Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"
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Day 2 - Day 28
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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.
Prazo: Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
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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
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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.
Prazo: Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
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Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"
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Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
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Time to therapeutic response (reduction in the severity of pain/discomfort in the upper abdomen according to VAS by 30% or more)
Prazo: Day 29 ± 1
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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
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Time to therapeutic response (reduction in the severity of pain/discomfort in the upper abdomen according to VAS by 50% or more)
Prazo: Day 29 ± 1
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Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"
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Day 29 ± 1
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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.
Prazo: Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
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Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"
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Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
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Time to clinical recovery (reduction in the severity of pain/discomfort in the upper abdomen according to VAS to 10 mm or less)
Prazo: Day 29 ± 1
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Visual analogue scale (VAS) from 0 to 100 mm, where 0 is "no pain", and 100 is "the worst pain one can imagine"
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Day 29 ± 1
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Change in the total score of gastroenterological symptom severity according to the GSRS questionnaire by days 8, 15, 22, and 29 following treatment initiation.
Prazo: Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
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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.
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Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
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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.
Prazo: Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
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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.
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Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
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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.
Prazo: Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
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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.
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Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
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Change in quality of life according to the total score on the SF-36 questionnaire by day 29 from treatment initiation.
Prazo: Day 29 ± 1
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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.
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Day 29 ± 1
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Change in the total score on the PAGI-SYM questionnaire by days 15 and 29 from treatment initiation.
Prazo: Day 15 ± 1, and 29 ± 1
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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.
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Day 15 ± 1, and 29 ± 1
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change in the total score on the Visceral Sensitivity Index questionnaire by days 15 and 29 from the start of therapy
Prazo: Day 15 ± 1, and 29 ± 1
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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.
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Day 15 ± 1, and 29 ± 1
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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
Prazo: Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
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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.
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Day 8 ± 1, 15 ± 1, 22 ± 1, and 29 ± 1
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Safety and Tolerability: adverse event (AE) rate
Prazo: From screening (and signing informed consent form) to the end of the study (Day 36 ± 2)
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Frequency of adverse events (AEs) or serious AEs (SAEs)
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From screening (and signing informed consent form) to the end of the study (Day 36 ± 2)
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Safety and Tolerability: adverse event (AE) number
Prazo: 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)
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From screening (and signing informed consent form) to the end of the study (Day 36 ± 2)
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Safety and Tolerability: AEs associated with the study drug
Prazo: From screening (and signing informed consent form) to the end of the study (Day 36 ± 2)
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Number and frequency of AEs associated with the study drug
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From screening (and signing informed consent form) to the end of the study (Day 36 ± 2)
|
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Safety and Tolerability: SAEs associated with the study drug
Prazo: From screening (and signing informed consent form) to the end of the study (Day 36 ± 2)
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Number and frequency of SAEs associated with the study drug
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From screening (and signing informed consent form) to the end of the study (Day 36 ± 2)
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Safety and Tolerability: treatment discontinuation
Prazo: From screening (and signing informed consent form) to the end of the study (Day 36 ± 2)
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Percentage of patients who discontinued treatment due to the occurrence of AEs/SAEs
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From screening (and signing informed consent form) to the end of the study (Day 36 ± 2)
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Physical examination results: respiratory system
Prazo: Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1
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An assessment of the condition of the respiratory system on physical examination (normal condition or list of abnormal conditions, if any)
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Screening, day 1, day 8 ± 1, day 15 ± 1, day 22 ± 1, day 29 ± 1
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Results of laboratory and instrumental examinations: blood chemistry - CRP
Prazo: Screening, day 15 ± 1, day 29 ± 1
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C-reactive protein, CRP (mg/L)
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Screening, day 15 ± 1, day 29 ± 1
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Safety and Tolerability: 12-lead electrocardiogram (ECG) - heart rate
Prazo: Screening, day 1, day 29 ± 1
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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)
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Screening, day 1, day 29 ± 1
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Safety and Tolerability: 12-lead electrocardiogram (ECG) - PQ interval
Prazo: Screening, day 1, day 29 ± 1
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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)
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Screening, day 1, day 29 ± 1
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Safety and Tolerability: 12-lead electrocardiogram (ECG) - QRS complex
Prazo: Screening, day 1, day 29 ± 1
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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)
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Screening, day 1, day 29 ± 1
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Safety and Tolerability: 12-lead electrocardiogram (ECG) - corrected QT interval
Prazo: Screening, day 1, day 29 ± 1
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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)
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Screening, day 1, day 29 ± 1
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
12 de dezembro de 2025
Conclusão Primária (Estimado)
31 de dezembro de 2027
Conclusão do estudo (Estimado)
31 de dezembro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
12 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
12 de maio de 2026
Primeira postagem (Real)
19 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
19 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de maio de 2026
Última verificação
1 de março de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- GIB-03-04-2025
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Placebo
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University of OxfordHospital General Universitario Gregorio Marañon; Charite University, Berlin,... e outros colaboradoresAinda não está recrutandoPsicose | Psicose Resistente ao TratamentoEspanha, Reino Unido, Alemanha, Israel, Grécia, Itália, Holanda, Suíça