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A Study to Evaluate the Efficacy and Safety of AD-203

NCT ID: NCT04066530

Last Updated: 2020-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

475 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-23

Study Completion Date

2020-02-26

Brief Summary

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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

Detailed Description

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Conditions

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Acute Gastritis Chronic Gastritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AD-203

Group Type EXPERIMENTAL

AD-203

Intervention Type DRUG

AD-203 administered two times daily for two weeks

Mucosta tab.

Group Type ACTIVE_COMPARATOR

Mucosta tab.

Intervention Type DRUG

Mucosta tab. administered three times daily for two weeks

Interventions

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AD-203

AD-203 administered two times daily for two weeks

Intervention Type DRUG

Mucosta tab.

Mucosta tab. administered three times daily for two weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Addpharma Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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JongJae Park, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Korea University Guro Hospital

Locations

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Korea University Guro Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AD-203P3

Identifier Type: -

Identifier Source: org_study_id