NCT06151210

Brief Summary

This study is to evaluate the efficacy and safety of DA-5219 in patients with acute or chronic gastritis

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
467

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 30, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 31, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2025

Completed
Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

1.4 years

First QC Date

November 21, 2023

Last Update Submit

August 21, 2025

Conditions

Gastritis AcuteGastritis Chronic

Outcome Measures

Primary Outcomes (1)

  • Improvement rate of gastric mucosal erosion

    Change from baseline at 2 weeks

Secondary Outcomes (5)

  • Cure rate for gastric mucosal erosion

    Change from baseline at 2 weeks

  • Cure rate for gastric mucosal edema

    Change from baseline at 2 weeks

  • Improvement rate for gastric mucosal erythema

    Change from baseline at 2 weeks

  • Improvement rate for gastric mucosal bleeding

    Change from baseline at 2 weeks

  • Improvement rate for gastric subjective symptoms

    Change from baseline at 2 weeks

Study Arms (2)

DA-5219

EXPERIMENTAL

administered for 2weeks(DA-5219 + Stillen® Tab placebo)

Drug: DA-5219Drug: Stillen® Tab Placebo

Stillen® Tab

ACTIVE COMPARATOR

administered for 2weeks(Stillen® Tab + DA-5219 placebo)

Drug: Stillen® TabDrug: DA-5219 Placebo

Interventions

DA-5219DRUG

1 tablet/day

DA-5219
Stillen® TabDRUG

3 tablets/day

Stillen® Tab
DA-5219 PlaceboDRUG

1 tablet/day

Stillen® Tab
Stillen® Tab PlaceboDRUG

3 tablets/day

DA-5219

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women aged ≥ 19 years and ≤ 75 years
  • Subjects who diagnosed with acute or chronic gastritis by upper gastrointestinal endoscopy within 7days prior to the randomization
  • Subjects who have one or more erosions identified on upper gastrointestinal endoscopy within 7days prior to the randomization
  • Subjects who voluntarily signed a consent form

You may not qualify if:

  • Ineligible for upper gastrointestinal endoscopy
  • Subjects with active or healing gastroduodenal ulcer, reflux esophagitis, Barrett's esophagus, or gastroesophageal varices identified on upper gastrointestinal endoscopy within 7days prior to the randomization
  • Subjects with hypersensitivity to investigational drugs and similar drugs
  • Pregnant or breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Interventions

DA 9601

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2023

First Posted

November 30, 2023

Study Start

January 31, 2024

Primary Completion

July 10, 2025

Study Completion

July 15, 2025

Last Updated

August 28, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

Locations

KR(1)