Clinical Trial to Evaluate the Efficacy and Safety of DA-5219 in Patients With Acute or Chronic Gastritis

Gastritis Chronic Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DA-5219 in Patients With Acute or Chronic Gastritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06151210
• Other study ID #: DA5219_GAS_III
• Status: Recruiting
• Phase: Phase 3
• Start date: January 31, 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Dong-A ST Co., Ltd.
• Contact: Hwoon-Yong Jung, Ph.D
• Phone: +82) 02-3010-3197
• Email: hwoonymd[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 452
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

Main Inclusion Criteria:

• 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

Main Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Gastritis
• Gastritis Acute
• Gastritis Chronic

Intervention

Drug:
• DA-5219
1 tablet/day
• Stillen® Tab
3 tablets/day
• DA-5219 Placebo
1 tablet/day
• Stillen® Tab Placebo
3 tablets/day

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement rate of gastric mucosal erosion		Change from baseline at 2 weeks
Secondary	Cure rate for gastric mucosal erosion		Change from baseline at 2 weeks
Secondary	Cure rate for gastric mucosal edema		Change from baseline at 2 weeks
Secondary	Improvement rate for gastric mucosal erythema		Change from baseline at 2 weeks
Secondary	Improvement rate for gastric mucosal bleeding		Change from baseline at 2 weeks
Secondary	Improvement rate for gastric subjective symptoms		Change from baseline at 2 weeks