Chronic Gastritis Clinical Trial
Official title:
A Randomized, Double-blinded, Active Controlled, Non-Inferiority, Multicenter, Phase III Clinical Trial to Evaluate the Efficacy and Safety of AD-203 in Patients With Acute or Chronic Gastritis
Verified date | December 2020 |
Source | Addpharma Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a multicenter, active-controlled , randomized, double-blinded, paralleled group clinical study to evaluate the efficacy and safety of AD-203 to demonstrate the non-inferiority of AD-203 compared with Mucosta tab. in patients with acute or chronic gastritis
Status | Completed |
Enrollment | 475 |
Est. completion date | February 26, 2020 |
Est. primary completion date | February 26, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 75 Years |
Eligibility | Inclusion Criteria: - Age is over 20 years old, under 75 years old, men or women - Patients diagnosed with acute or chronic gastritis by gastroscopy Exclusion Criteria: - Patients who is impossible to receive gastroscopy - Patients taking other investigational drugs or participating in other clinical studies in 3 months prior to screening visit |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Korea University Guro Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Addpharma Inc. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | A percentage of subjects showed improvement of stomach erosions by the endoscopy. | Evaluate the improvement rate of "Very much improved' and "Much improved" of subjects with stomach erosions.
The definition of "Very Much Improved" is the subjects showed score changed from 4 to 1 or from 3 to 1. And, "Much improved" means the subject showed score changed from 4 to 2 or from 2 to 1. |
2 weeks |
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