Status:
COMPLETED
A Study to Evaluate the Safety and Efficacy of DA9601 for Acute and Chronic Gastritis and to Determine the Optimal Clinical Dosage and Administration
Lead Sponsor:
Dong-A ST Co., Ltd.
Conditions:
Acute Gastritis
Chronic Gastritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 g...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 14 1997
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 1999
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT07139886
Start Date
March 14 1997
End Date
July 8 1999
Last Update
August 29 2025
Active Locations (1)
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1
Ajou University Medical Center, Division of Gastroenterology
Suwon, Gyeonggi-do, South Korea, 16499