Phase 4 Study of Sto M Tab. in Acute or Chronic Gastritis
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
Aperçu de l'étude
Statut
Statut
Les conditions
Les conditions
Intervention / Traitement
Intervention / Traitement
Description détaillée
Type d'étude
Type d'étude
Inscription (Estimé)
Inscription
Phase
Phase
- Phase 4
Critères de participation
Critère d'éligibilité
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Nombre de bras
Armes et Interventions
Groupe de participants / BrasGroupe de participants / Bras |
Intervention / TraitementIntervention / Traitement |
|---|---|
|
Expérimental: Sto M Tab. Group
|
Sto M Tab., oral, three times daiy, 2 weeks
|
|
Comparateur actif: Stillen Tab. Group
|
Stillen Tab., oral, three times daily, 2 weeks
|
Que mesure l'étude ?
Principaux critères de jugement
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Effective Rate of Gastric Mucosal Erosion Assessed by an Independent Reviewer
Délai: 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
|
Mesures de résultats secondaires
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Effective Rate of Gastric Mucosal Erosion Assessed by the Investigator
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Début de l'étude
Achèvement primaire (Estimé)
Achèvement primaire
Achèvement de l'étude (Estimé)
Achèvement de l'étude
Dates d'inscription aux études
Première soumission
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Première publication
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour publiée
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
Autres numéros d'identification d'étude
- MTS-STO-401
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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