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

Dong-A ST

Status and phase: Completed; Phase 3

Conditions: Gastritis Chronic; Gastritis Acute

Treatments: Drug: DA-5219 Placebo; Drug: Stillen® Tab; Drug: Stillen® Tab Placebo; Drug: DA-5219

Study type: Interventional

Funder types: Industry

Identifiers

NCT06151210

DA5219_GAS_III

Details and patient eligibility

About

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

Enrollment: 467 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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467 participants in 2 patient groups

DA-5219

Experimental group

Description:

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

Treatment:

Drug: DA-5219

Drug: Stillen® Tab Placebo

Stillen® Tab

Active Comparator group

Description:

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

Treatment:

Drug: Stillen® Tab

Drug: DA-5219 Placebo