A Study to Evaluate the Safety and Efficacy of DA9601 for Acute and Chronic Gastritis and to Determine the Optimal Clinical Dosage and Administration

Not Applicable

Completed

• Conditions: Acute Gastritis; Chronic Gastritis
• Interventions: Drug: Stillen® Tab Placebo; Drug: Stillen® Tab

• Registration Number: NCT07139886
• Lead Sponsor: Dong-A ST Co., Ltd.

Brief Summary

This is a multicenter, placebo-controlled, randomized, double-blinded, paralleled group clinical study to evaluate the efficacy of 2-week treatment with DA-9601 tab in patients with acute or chronic gastritis. Subject will receive DA-9601 180mg, 360mg tab or Placebo., three times a day for two weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-03-14
• Primary Completion: 1999-07-08
• Study Completion: 1999-07-08
• Status Verified: 2025-08
• Study First Submitted: 2025-08-18
• Study First Submitted QC: 2025-08-18
• Last Update Submitted: 2025-08-18
• Study First Posted: 2025-08-24
• Last Update Posted: 2025-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 212

Inclusion Criteria

• Patients who are diagnosed with acute gastritis and chronic gastritis by endoscopy; have gastric mucosal lesions such as erosion, bleeding, redness, swelling on the site; and have subjective and objective symptoms requiring medical treatment ② 18 years old or older, 75 years old or younger ③ Patients who have agreed with the terms of clinical trials

Exclusion Criteria

• Patients with peptic ulcer (excluding scars) and reflux esophagitis

  • Patients who were administered with H2 antagonist, muscarine receptor antagonist or nonsteroidal anti-inflammatory drug within 2 weeks prior to the start of the trial

    • Patients using protective agent enhancers at the start of the trial ④ Patients with recurrence observed during maintenance therapy at the start of the trial

      • Patients with a history of gastrectomy

        • Patients with severe disorders of the liver, kidneys, heart, lungs, blood, etc. ⑦ Patients with duodenal ulcer ⑧ Patients with gastrointestinal malignancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Stillen® Tab Placebo	administered 2 tablets of placebo three times daily for four weeks
DA-9601 180mg	Stillen® Tab	administered 1 tablet of placebo and 1 talblet of DA-9601 three times daily for four weeks
DA-9601 360mg	Stillen® Tab	administered 2 talblets of DA-9601 three times daily for four weeks
DA-9601 180mg	Stillen® Tab Placebo	administered 1 tablet of placebo and 1 talblet of DA-9601 three times daily for four weeks

Primary Outcome Measures

Name	Time	Method
Change in Subjective and Objective Symptoms, Gastroscopy, Overall Improvement, Effectiveness grade	2 weeks	evaluated in 5 levels of "Significant improvement • Moderate improvement • Mild improvement • No improvement • Exacerbation"

Trial Locations

Locations (1)

Ajou University Medical Center, Division of Gastroenterology; 🇰🇷 Suwon, Gyeonggi-do, Korea, Republic of