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 range18 Years – 75 Years
SexALL
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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 â‘¡ 18 years old or older, 75 years old or younger â‘¢ 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 â‘£ 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
What they're measuring
1
Change in Subjective and Objective Symptoms, Gastroscopy, Overall Improvement, Effectiveness grade