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

NCT07139886 | Completed Phase 2

• 1 other identifier: DA9601_GAS_IIb
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

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

  2 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

administered 2 tablets of placebo three times daily for two weeks

Drug: Stillen® Tab Placebo

DA-9601(Stillen®) 180mg

EXPERIMENTAL

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

Drug: Stillen® Tab; Drug: Stillen® Tab Placebo

DA-9601(Stillen®) 360mg

EXPERIMENTAL

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

Drug: Stillen® Tab

Interventions

Stillen® Tab DRUG

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

DA-9601(Stillen®) 180mg; DA-9601(Stillen®) 360mg

Stillen® Tab Placebo DRUG

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

DA-9601(Stillen®) 180mg; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead

Study Sites (1)

Ajou University Medical Center, Division of Gastroenterology

Suwon, Gyeonggi-do, 16499, South Korea

Location

MeSH Terms

Interventions

DA 9601

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 24, 2025
• Study Start: March 14, 1997
• Primary Completion: July 8, 1999
• Study Completion: July 8, 1999
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

KR (1)