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

NCT ID: NCT07139886

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 212 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-03-14
• Study Completion Date: 1999-07-08

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.

Conditions

Acute Gastritis; Chronic Gastritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

administered 2 tablets of placebo three times daily for two weeks

Group Type: PLACEBO_COMPARATOR

Stillen® Tab Placebo

Intervention Type: DRUG

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

DA-9601(Stillen®) 180mg

administered 1 tablet of placebo and 1 tablet of DA-9601(Stillen®) three times daily for two weeks

Group Type: EXPERIMENTAL

Stillen® Tab

Intervention Type: DRUG

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

Stillen® Tab Placebo

Intervention Type: DRUG

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

DA-9601(Stillen®) 360mg

administered 2 tablets of DA-9601(Stillen®) three times daily for two weeks

Group Type: EXPERIMENTAL

Stillen® Tab

Intervention Type: DRUG

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

Interventions

Stillen® Tab

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

Intervention Type: DRUG

Stillen® Tab Placebo

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ajou University Medical Center, Division of Gastroenterology

Suwon, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

DA9601_GAS_IIb

Identifier Type: -

Identifier Source: org_study_id