A Multicenter, Double Blinded, Randomized, Parallel Assignment Study to Demonstrate the Efficacy of DA9601

Summary

This is a phase IV clinical study to evaluate the preventive effectiveness of NSAID-Associated Gastroduodenal Injury. The study is consisted of multi-center, doubleblind, active-controlled, stratified randomized, parallel group. A tablet of DA9601, Cytotec (200ug of Misoprostol), Acrofen (100mg of Aceclofenac) will be assigned randomly to the subjects for four weeks.

Conditions

• NSAID-associated Gastroduodenal Injury

Interventions

DRUG

Stillen

DRUG

Cytotec (reference drug)

DRUG

NSAID (Aceclofenac)

Sponsors & Collaborators

• Dong-A ST Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Sang-Yong Seol, MD · Inje University

• Myoung-Gyu Choi, MD · The Catholic University of Korea

• Oh Young Lee, MD · Hanyang University

• Dong Ho Lee, MD · Seoul National University Bundang Hospital

• Yong Chan Lee, MD · Severance Hospital

• Suck Chei Choi, MD · Wonkwang University School of Medicine & Hospital

• Jong Sun Rew, MD · Chonnam National University Hospital

• Kang Moon Lee · Saint Vincent's Hospital, Korea

• Jae Young Jang, MD · Kyunghee University Medical Center

• Hoon-jai Chun, MD · Korea University Anam Hospital

• Sang-woo Lee, MD · Korea University Ansan Hospital

• Moo In Park, MD · Kosin University Gospel Hospital

• Joong Goo Kwon, MD · Daegu Catholic University Medical Center

• Geunam Song, MD · Pusan National University Hospital

• Seong Woo Jeon, MD · Kyungpook National University Medical Center

• Soo Taek Lee, MD · Chonbuk National University Hospital

• Jae Gyu Kim, MD · Chung-Ang University Hosptial, Chung-Ang University College of Medicine

• Poong-Lyul Rhee, MD · Samsung Medical Center

• Kwang Jae Lee, MD · Ajou University School of Medicine

• Hyo Jin Park, MD · Gangnam Severance Hospital

• Byung Ik Jang, MD · Yeungnam University Hospital

• Yong Woon Shin, MD · Inha University Hospital

• Dong Soo Han, MD · Hanyang University

• Sung Kook Kim, MD · Kyungpook National University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-09-30

Primary Completion

2014-03-31

Completion

2014-03-31

Countries

• South Korea

Study Locations