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- Ensaio Clínico NCT07631065
Phase 4 Study of Sto M Tab. in Acute or Chronic Gastritis
1 de junho de 2026 atualizado por: Mather's Pharm. Co., Ltd.
A Randomized, Double-blinded, Active Controlled, Non-Inferiority, Multicenter, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Sto M Tab. in Patients With Acute or Chronic Gastritis
This Phase 4, multicenter, randomized, double-blind, active-controlled, non-inferiority study aims to evaluate the non-inferiority of Stoem Tab. compared to Stillen Tab.
(Dong-A ST Co., Ltd.) in patients with acute or chronic gastritis.
Participants will receive either Stoem Tab. or Stillen Tab. for 2 weeks.
The primary outcome is the effective rate of gastric mucosal erosion at Week 2, assessed by upper gastrointestinal endoscopy and evaluated by an independent reviewer, defined as the proportion of participants achieving at least a 50% improvement in erosion score compared to baseline.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
This Phase 4 clinical trial will assess the efficacy and safety of Stoem Tab. compared to Stillen Tab. in adults with acute or chronic gastritis.
Participants will be randomized in a double-blind, parallel, active-controlled design to receive either Stoem Tab. or Stillen Tab. for 2 weeks.
The primary endpoint is the effective rate of gastric mucosal erosion at Week 2, assessed by upper gastrointestinal endoscopy and evaluated by an independent reviewer.
A responder is defined as a participant whose erosion score at Week 2 has improved by at least 50% compared to baseline (i.e., a decrease from grade 4 to grade 2 or 1, or from grade 3 or 2 to grade 1).
The effective rate is calculated as the proportion of responders among the evaluable participants.
Secondary endpoints include additional efficacy and safety evaluations.
The study aims to demonstrate the non-inferiority of Stoem Tab. to Stillen Tab.
All participants will be monitored for efficacy, safety, and medication compliance, and standard eligibility criteria will be applied.
Tipo de estudo
Intervencional
Inscrição (Estimado)
470
Estágio
- Fase 4
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:
- Male or female adults aged 19 to 75 years at the time of screening.
- Participants diagnosed with acute or chronic gastritis by upper gastrointestinal endoscopy performed within 7 days prior to randomization (Visit 2), with at least one gastric erosion confirmed. Erosions of the esophagus and duodenum are excluded.
- Female participants of childbearing potential or male participants who agree to maintain sexual abstinence or use appropriate contraceptive methods during the study period and for 2 weeks after the last administration of the investigational product. Periodic abstinence, such as calendar, ovulation, symptothermal, or post-ovulation methods, is not considered an acceptable contraceptive method.
- Participants who voluntarily provide written informed consent to participate in this clinical trial.
Exclusion Criteria:
- Participants with any of the following lesions confirmed or accompanied by upper gastrointestinal endoscopy at screening (Visit 1): active or healing peptic ulcer; reflux esophagitis; Barrett's esophagus greater than 3 cm; gastroesophageal varices; esophageal stricture; or other clinically relevant lesions. Participants with ulcer scars may be enrolled.
- Participants who have a history of gastric acid secretion-inhibiting surgery or gastric or esophageal surgery at screening (Visit 1).
- Participants who have been diagnosed with or have a history of Zollinger-Ellison syndrome at screening (Visit 1).
- Participants with inflammatory bowel disease, such as Crohn's disease, ulcerative colitis, or intestinal Behcet's disease; primary esophageal motility disorder; or pancreatitis at screening (Visit 1).
- Participants with a history of malignancy within 5 years prior to screening (Visit 1). However, participants who have been completely treated and have had no recurrence for at least 5 years may be enrolled at the investigator's discretion. Participants with gastrointestinal malignancy are excluded regardless of the time since diagnosis. Participants with basal cell carcinoma, squamous cell carcinoma of the skin, thyroid cancer, or carcinoma in situ of other sites may be enrolled at the investigator's discretion if they have been completely treated and have had no recurrence for at least 3 years.
- Participants with current or prior thrombotic disease at screening (Visit 1), such as cerebral thrombosis, myocardial infarction, thrombophlebitis, or venous thrombosis.
- Participants diagnosed with disseminated intravascular coagulation at screening (Visit 1).
- Participants with concomitant hepatic, renal, cardiac, pulmonary, hematologic, or other diseases that, in the investigator's judgment, may affect the efficacy or safety evaluations.
- Participants with current or prior lipid metabolism disorders at screening (Visit 1), such as hyperlipidemia or diabetic hyperlipidemia, or participants who require cautious administration of lipid nutritional products. However, participants whose condition is adequately controlled with medication may be enrolled at the investigator's discretion.
- Participants with hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- Participants with a history of hypersensitivity to soybean, peanut, or soybean oil.
- Participants with a history of hypersensitivity to any component of the investigational products, such as tartrazine.
- Participants with clinically significant psychiatric disease at screening (Visit 1).
- Participants who meet any other exclusion criteria related to prior or concomitant medications specified in the protocol.
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: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Sto M Tab. Group
|
Sto M Tab., oral, three times daiy, 2 weeks
|
|
Comparador Ativo: Stillen Tab. Group
|
Stillen Tab., oral, three times daily, 2 weeks
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Effective Rate of Gastric Mucosal Erosion Assessed by an Independent Reviewer
Prazo: Baseline and Week 2
|
Proportion of participants whose erosion score improved by at least 50% from baseline to Week 2, as assessed by upper gastrointestinal endoscopy and evaluated by an independent reviewer.
|
Baseline and Week 2
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Effective Rate of Gastric Mucosal Erosion Assessed by the Investigator
Prazo: Baseline and Week 2
|
Proportion of participants whose erosion score improved by at least 50% from baseline to Week 2, as assessed by upper gastrointestinal endoscopy.
|
Baseline and Week 2
|
|
Complete Cure Rate of Gastric Mucosal Erosion Assessed by the Investigator
Prazo: Week 2
|
Proportion of participants with complete resolution of gastric mucosal erosion at Week 2, as assessed by upper gastrointestinal endoscopy.
|
Week 2
|
|
Complete Cure Rate of Gastric Mucosal Edema Assessed by the Investigator
Prazo: Week 2
|
Proportion of participants with complete resolution of gastric mucosal edema at Week 2, as assessed by upper gastrointestinal endoscopy.
|
Week 2
|
|
Effective Rate of Gastric Mucosal Redness Assessed by the Investigator
Prazo: Baseline and Week 2
|
Proportion of participants whose redness score improved by at least 50% from baseline to Week 2, as assessed by upper gastrointestinal endoscopy.
|
Baseline and Week 2
|
|
Effective Rate of Gastric Mucosal Hemorrhage Assessed by the Investigator
Prazo: Baseline and Week 2
|
Proportion of participants whose hemorrhage score improved by at least 50% from baseline to Week 2, as assessed by upper gastrointestinal endoscopy.
|
Baseline and Week 2
|
|
Improvement Rate of Subjective Symptom Score Assessed by the Investigator
Prazo: Baseline and Week 2
|
Proportion of participants whose total subjective symptom score improved by at least 50% from baseline to Week 2, as assessed by a self-reported questionnaire.
|
Baseline and Week 2
|
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 (Estimado)
1 de junho de 2026
Conclusão Primária (Estimado)
1 de fevereiro de 2028
Conclusão do estudo (Estimado)
1 de fevereiro de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
1 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
1 de junho de 2026
Primeira postagem (Real)
5 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
5 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
1 de junho de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- MTS-STO-401
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 .
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