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A Study to Evaluate the Efficacy and Safety of DA-6034 and to Demonstrate the Non-inferiority of DA-6034

NCT01813812 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 492

Last updated 2013-03-22

No results posted yet for this study

Summary

This is a multicenter, double-blinded, double-dummy, active-controlled, randomized, Phase III clinical trial to evaluate the efficacy and safety of DA-6034 and to demonstrate the non-inferiority of DA-6034 compared with Rebamipide in patients with acute or chronic gastritis. Subjects will receive 45mg, 90mg of DA-6034 and 300mg of Rebamipide, two tablets, three times a day for two weeks.

Conditions

  • Acute Gastritis
  • Chronic Gastritis

Interventions

DRUG

DA-6034

DRUG

Rebamipide 300mg

Sponsors & Collaborators

  • Dong-A Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Hyun Chae Jung, M.D., Ph.D. · Seoul National University Hospital

  • Soo Heon Park, M.D., Ph.D. · Catholic University Yeouido St. Mary's Hopspital

  • Seong Woo Jeon, M.D., Ph.D. · Kyungpook National University Hospital

  • Sang Woo Lee, M.D.,Ph.D. · Korea University Ansan Hospital

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

  • Kook Lae Lee, M.D., Ph.D. · SMG-SNU Boramae Medical Center

  • Ju Yung Cho, M.D., Ph.D. · Soonchunhyang University Hospital

  • Ki Myeong Lee, M.D., Ph.D. · Ajou University School of Medicine

  • Yongchan Lee, M.D., Ph.D. · Severance Hospital, Yonsei University

  • Sang Yong Seol, M.D., Ph.D. · Inje University

  • Jeong Seop Moon, M.D., Ph.D. · Inje University

  • Jong Sun Rew, M.D., Ph.D. · Chonnam National University Hospital

  • Soo Taek Lee, M.D., Ph.D. · Chonbuk National University Hospital

  • Chan Kook Park, M.D., Ph.D. · Chosun University Hospital

  • Jae Gyu Kim, M.D., Ph.D. · Chung-Ang University Hosptial, Chung-Ang University College of Medicine

  • Sei Jin Youn, M.D., Ph.D. · Chungbuk National University Hospital

  • Hak Yang Kim, M.D., Ph.D. · Hallym University Medical Center

  • Byung Chul Yoon, M.D., Ph.D. · Hanyang University

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

  • Ki Nam Shim, M.D., Ph.D. · Ewha Womans University Mokdong Hospital

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
2010-10-31
Primary Completion
2013-08-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01813812 on ClinicalTrials.gov