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Phase 4 Study of Sto M Tab. in Acute or Chronic Gastritis

2026年6月1日 更新者: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.

調査の概要

状態

まだ募集していません

詳細な説明

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.

研究の種類

介入

入学 (推定)

470

段階

  • フェーズ 4

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  1. Male or female adults aged 19 to 75 years at the time of screening.
  2. 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.
  3. 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.
  4. Participants who voluntarily provide written informed consent to participate in this clinical trial.

Exclusion Criteria:

  1. 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.
  2. Participants who have a history of gastric acid secretion-inhibiting surgery or gastric or esophageal surgery at screening (Visit 1).
  3. Participants who have been diagnosed with or have a history of Zollinger-Ellison syndrome at screening (Visit 1).
  4. 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).
  5. 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.
  6. Participants with current or prior thrombotic disease at screening (Visit 1), such as cerebral thrombosis, myocardial infarction, thrombophlebitis, or venous thrombosis.
  7. Participants diagnosed with disseminated intravascular coagulation at screening (Visit 1).
  8. Participants with concomitant hepatic, renal, cardiac, pulmonary, hematologic, or other diseases that, in the investigator's judgment, may affect the efficacy or safety evaluations.
  9. 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.
  10. Participants with hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
  11. Participants with a history of hypersensitivity to soybean, peanut, or soybean oil.
  12. Participants with a history of hypersensitivity to any component of the investigational products, such as tartrazine.
  13. Participants with clinically significant psychiatric disease at screening (Visit 1).
  14. Participants who meet any other exclusion criteria related to prior or concomitant medications specified in the protocol.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的:Sto M Tab. Group
Sto M Tab., oral, three times daiy, 2 weeks
アクティブコンパレータ:Stillen Tab. Group
Stillen Tab., oral, three times daily, 2 weeks

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Effective Rate of Gastric Mucosal Erosion Assessed by an Independent Reviewer
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Effective Rate of Gastric Mucosal Erosion Assessed by the Investigator
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

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研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年6月1日

一次修了 (推定)

2028年2月1日

研究の完了 (推定)

2028年2月1日

試験登録日

最初に提出

2026年6月1日

QC基準を満たした最初の提出物

2026年6月1日

最初の投稿 (実際)

2026年6月5日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月5日

QC基準を満たした最後の更新が送信されました

2026年6月1日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • MTS-STO-401

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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Sto M Tab.の臨床試験

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