Acute Gastritis, Chronic Gastritis
Conditions
Brief summary
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
Interventions
DRUGAD-203
AD-203 administered two times daily for two weeks
DRUGMucosta tab.
Mucosta tab. administered three times daily for two weeks
Sponsors
Addpharma Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A percentage of subjects showed improvement of stomach erosions by the endoscopy. | 2 weeks | 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. |
Countries
South Korea
Outcome results
None listed