NCT04066530

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
475

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2019

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 26, 2019

Completed
28 days until next milestone

Study Start

First participant enrolled

September 23, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2020

Completed
Last Updated

December 2, 2020

Status Verified

December 1, 2020

Enrollment Period

5 months

First QC Date

August 21, 2019

Last Update Submit

December 1, 2020

Conditions

Acute GastritisChronic Gastritis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

AD-203

EXPERIMENTAL
Drug: AD-203

Mucosta tab.

ACTIVE COMPARATOR
Drug: Mucosta tab.

Interventions

AD-203DRUG

AD-203 administered two times daily for two weeks

AD-203
Mucosta tab.DRUG

Mucosta tab. administered three times daily for two weeks

Mucosta tab.

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age is over 20 years old, under 75 years old, men or women
  • Patients diagnosed with acute or chronic gastritis by gastroscopy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Guro Hospital

Seoul, South Korea

Location

Study Officials

  • JongJae Park, Ph.D

    Korea University Guro Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2019

First Posted

August 26, 2019

Study Start

September 23, 2019

Primary Completion

February 26, 2020

Study Completion

February 26, 2020

Last Updated

December 2, 2020

Record last verified: 2020-12

Locations

KR(1)