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

• Sponsor: Dong-A ST Co., Ltd. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06151210
• Collaborator: (none)
• Enrollment: 452
• Arms: 2
• Anticipated Duration (Months): 11

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Gastritis Acute; Gastritis Chronic	Drug: DA-5219; Drug: Stillen® Tab; Drug: DA-5219 Placebo; Drug: Stillen® Tab Placebo	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 452 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Dec 1, 2023
• Anticipated Primary Completion Date: Nov 1, 2024
• Anticipated Study Completion Date: Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DA-5219 administered for 2weeks(DA-5219 + Stillen® Tab placebo)	Drug: DA-5219; 1 tablet/day; Drug: Stillen® Tab Placebo; 3 tablets/day
Active Comparator: Stillen® Tab administered for 2weeks(Stillen® Tab + DA-5219 placebo)	Drug: Stillen® Tab; 3 tablets/day; Drug: DA-5219 Placebo; 1 tablet/day

Outcome Measures

Primary Outcome Measures

1. Improvement rate of gastric mucosal erosion [Change from baseline at 2 weeks]

Secondary Outcome Measures

1. Cure rate for gastric mucosal erosion [Change from baseline at 2 weeks]

2. Cure rate for gastric mucosal edema [Change from baseline at 2 weeks]

3. Improvement rate for gastric mucosal erythema [Change from baseline at 2 weeks]

4. Improvement rate for gastric mucosal bleeding [Change from baseline at 2 weeks]

5. Improvement rate for gastric subjective symptoms [Change from baseline at 2 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Dong-A ST Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dong-A ST Co., Ltd.
• ClinicalTrials.gov Identifier: NCT06151210
• Other Study ID Numbers: DA5219_GAS_III
• First Posted: Nov 30, 2023
• Last Update Posted: Nov 30, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Gastritis

Study Results

No Results Posted as of Nov 30, 2023