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

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.

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Key information

Conditions

Acute Gastritis Chronic Gastritis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ajou University Medical Center, Division of Gastroenterology

Suwon, Gyeonggi-do, 16499, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stillen® Tab

Drug

Oral administration 3 times per day (in-between meals and before sleep) for 2 weeks

Stillen® Tab Placebo

Drug

Oral administration 3 times per day (in-between meals and before sleep) for 2 weeks

Primary outcomes

Change in Subjective and Objective Symptoms, Gastroscopy, Overall Improvement, Effectiveness grade

Time frame: 2 weeks

evaluated in 5 levels of "Significant improvement • Moderate improvement • Mild improvement • No improvement • Exacerbation"

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

Phase 2b Multi-center Clinical Trials to Clarify the Efficacy and Adaptation Target of DA9601 in Patients With Acute and Chronic Gastritis, and to Determine the Optimal Clinical Dosage and Administration.

Important dates

Study start: 1997
Primary completion: 1999
Study completion: 1999
First posted: Aug 24, 2025
Registry last updated: Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed