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

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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07139886

Enrollment

212

Registered

2025-08-24

Start date

1997-03-14

Completion date

1999-07-08

Last updated

2025-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Gastritis, Chronic Gastritis

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.

Interventions

DRUGStillen® Tab

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

DRUGStillen® Tab Placebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026