A Study to Evaluate the Safety and Efficacy of DA9601 for Acute and Chronic Gastritis and to Dete… (NCT07139886) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Safety and Efficacy of DA9601 for Acute and Chronic Gastritis and to Determine the Optimal Clinical Dosage and Administration
South Korea212 participantsStarted 1997-03-14
Plain-language summary
This is a multicenter, placebo-controlled, randomized, double-blinded, paralleled group clinical study to evaluate the efficacy of 2-week treatment with DA-9601 tab in patients with acute or chronic gastritis. Subject will receive DA-9601 180mg, 360mg tab or Placebo., three times a day for two weeks.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients who are diagnosed with acute gastritis and chronic gastritis by endoscopy; have gastric mucosal lesions such as erosion, bleeding, redness, swelling on the site; and have subjective and objective symptoms requiring medical treatment ② 18 years old or older, 75 years old or younger ③ Patients who have agreed with the terms of clinical trials
Exclusion Criteria:
* Patients with peptic ulcer (excluding scars) and reflux esophagitis
* Patients who were administered with H2 antagonist, muscarine receptor antagonist or nonsteroidal anti-inflammatory drug within 2 weeks prior to the start of the trial
* Patients using protective agent enhancers at the start of the trial ④ Patients with recurrence observed during maintenance therapy at the start of the trial
* Patients with a history of gastrectomy
* Patients with severe disorders of the liver, kidneys, heart, lungs, blood, etc. ⑦ Patients with duodenal ulcer ⑧ Patients with gastrointestinal malignancy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Subjective and Objective Symptoms, Gastroscopy, Overall Improvement, Effectiveness grade