Evaluating DA-5219 for treating acute or chronic gastritis
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
This study is testing a new medication called DA-5219 to see if it can help people with acute or chronic gastritis feel better and heal their stomach issues.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 452 (estimated) |
| Ages | 19 Years to 75 Years |
| Sex | All |
| Sponsor | Dong-A ST Co., Ltd. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06151210 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy and safety of DA-5219 in patients diagnosed with acute or chronic gastritis. Participants will be randomly assigned to receive either DA-5219 or a placebo, with the study focusing on those who have erosions identified through upper gastrointestinal endoscopy. The trial will include men and women aged 19 to 75 years, ensuring a thorough evaluation of the treatment's impact on gastritis symptoms and healing. The study will be conducted at Asan Medical Center in Seoul.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 19 to 75 who have been diagnosed with acute or chronic gastritis and have erosions identified via endoscopy.
Not a fit: Patients with active or healing gastroduodenal ulcers, reflux esophagitis, or other specified gastrointestinal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide effective relief and healing for patients suffering from acute or chronic gastritis.
How similar studies have performed: While the specific approach of DA-5219 is novel, similar studies evaluating treatments for gastritis have shown varying degrees of success.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Seoul
- Asan Medical Center — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Hwoon-Yong Jung, Ph.D
- Email: hwoonymd@gmail.com
- Phone: +82) 02-3010-3197
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.