A Study to Evaluate the Efficacy and Safety of DA-5204

Summary

This is a multicenter, active-controlled, randomized, double-blinded, paralleled group clinical study to evaluate the efficacy and safety of DA-5204 and to demonstrate the non-inferiority of DA-5204 compared with Stillen® tab. in patients with acute or chronic gastritis.

Conditions

• Acute Gastritis
• Chronic Gastritis

Interventions

DRUG

DA-5204

DRUG

Stillen tab.

Sponsors & Collaborators

• Dong-A ST Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Dong Ho Lee, M.D., Ph.D. · Seoul National University Bundang Hospital of Korea

• Myung Gyu Choi, M.D., Ph.D. · The Catholic University, Seoul St. Mary's Hospital of Korea

• Sung Joon Lee, M.D., Ph.D. · Kangwon National University Hospital of Korea

• Sung Kuk Kim, M.D., Ph.D. · Kyungbuk National University Hospital of Korea

• Geun Am Song, M.D., Ph.D. · Pusan National Universtiy Hospital of Korea

• Poong Lyeol Lee, M.D., Ph.D. · Samsung Medical Center of Korea

• Hwoon Yong Jung, M.D., Ph.D. · Asan Medical Center of Korea

• Dae Hwan Kang, M.D., Ph.D. · Pusan National University Yangsan Hospital of Korea

• Yong Chan Lee, M.D., Ph.D. · Yonsei University, Severance Hospital of Korea

• Si Hyung Lee, M.D., Ph.D. · Yeungnam University Hospital of Korea

• Suck Chei Choi, M.D., Ph.D. · Wonkwang University Hospital of Korea

• Gi Nam Sim, M.D., Ph.D. · Ewha Womans University Medical Center of Korea

• Sang Young Seoul, M.D., Ph.D. · Inje University Busan Paik Hospital of Korea

• Jeong Seop Moon, M.D., Ph.D. · Inje University Seoul Paik Hospital of Korea

• Yong Woon Shin, M.D., Ph.D. · Inha University Hospital of Korea

• Hyen Soo Kim, M.D., Ph.D. · Chonnam National Universtiy Hospital of Korea

• Soo Teik Lee, M.D., Ph.D. · Chonbuk National Universtiy Hospital of Korea

• Jin Woong Cho, M.D., Ph.D. · The Presbyterian medical center in Jeonju of Korea

• Eun Kwang Choi, M.D., Ph.D. · Jeju National Universtiy Hospital of Korea

• Soon Man Yoon, M.D., Ph.D. · Chungbuk National University Hospital of Korea

• Oh Young Lee, M.D., Ph.D. · Hanyang Universtiy Hospital of Korea

• Jin Seok Jang, M.D., Ph.D. · Dong-A University Hospital of Korea

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-04-30

Primary Completion

2014-11-30

Completion

2014-11-30

Countries

• South Korea

Study Locations