Back to resultsA Study to Evaluate the Efficacy and Safety of AD-203
Primary Purpose
Acute Gastritis, Chronic Gastritis
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
AD-203
Mucosta tab.
Sponsored by
About this trial
This is an interventional treatment trial for Acute Gastritis
Eligibility Criteria
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
Sites / Locations
- Korea University Guro Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
AD-203
Mucosta tab.
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04066530
Brief Title
A Study to Evaluate the Efficacy and Safety of AD-203
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
September 23, 2019 (Actual)
Primary Completion Date
February 26, 2020 (Actual)
Study Completion Date
February 26, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Addpharma Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Gastritis, Chronic Gastritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
475 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AD-203
Arm Type
Experimental
Arm Title
Mucosta tab.
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
AD-203
Intervention Description
AD-203 administered two times daily for two weeks
Intervention Type
Drug
Intervention Name(s)
Mucosta tab.
Intervention Description
Mucosta tab. administered three times daily for two weeks
Primary Outcome Measure Information:
Title
A percentage of subjects showed improvement of stomach erosions by the endoscopy.
Description
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.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JongJae Park, Ph.D
Organizational Affiliation
Korea University Guro Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of AD-203
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