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

Overview

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.

Full Title of Study: “A Phase 3 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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2013

Interventions

  • Drug: DA-6034
  • Drug: Rebamipide 300mg

Arms, Groups and Cohorts

  • Experimental: DA-6034 45mg
    • two tablets (of DA-6034 45mg) are administered for 2 continuous weeks, three times a day.
  • Experimental: DA-6034 90mg
    • two tablets (of DA-6034 90mg) are administered for 2 continuous weeks, three times a day.
  • Active Comparator: Rebamipide 300mg
    • two tablets (of Rebamipide 300mg) are administered for 2 continuous weeks, three times a day.

Clinical Trial Outcome Measures

Primary Measures

  • The number of erosions comparing the before and after the administration. For example, if the number of the erosion is 0, the score is 1 (normal).
    • Time Frame: 2 weeks
    • The scale is classified into 5 steps which are based on the severity of the improvement. EX) noticable improvement: 4->1, 3->1, slight improvement: 4->3, 3->2

Secondary Measures

  • The number of erosions diagnosed by the gastroscope
    • Time Frame: 2 weeks
  • The severity of the digestive symptoms (Scale of 1 to 5)
    • Time Frame: 2 weeks
    • the example of the symptoms are: epigastralgia, heartburn, acid reflux, nausea, domperidone

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosed with acute gastritis or chronic gastritis – 1 or more erosions found in the gastroscope examination – Age should be: 20≤age≤75 Exclusion Criteria:

  • A patient with peptic ulcer and a gastroesophageal reflux disease. – Received a medication including non-steroid anti-inflammatory drug 2 weeks before the initiation – Had a surgery regarding gastroesophageal – A patient with Zollinger-Ellison syndrome – Had a medical history of a malignant tumor – A patient who is currently taking anti-thrombotic drugs

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Dong-A Pharmaceutical Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Hyun Chae Jung, M.D., Ph.D., Principal Investigator, Seoul National University Hospital
    • Soo Heon Park, M.D., Ph.D., Principal Investigator, Catholic University Yeouido St. Mary’s Hopspital
    • Seong Woo Jeon, M.D., Ph.D., Principal Investigator, Kyungpook National University Hospital
    • Sang Woo Lee, M.D.,Ph.D., Principal Investigator, Korea University Ansan Hospital
    • Dong Ho Lee, M.D.,Ph.D., Principal Investigator, Seoul National University Bundang Hospital
    • Kook Lae Lee, M.D., Ph.D., Principal Investigator, SMG-SNU Boramae Medical Center
    • Ju Yung Cho, M.D., Ph.D., Principal Investigator, Soonchunhyang University Hospital
    • Ki Myeong Lee, M.D., Ph.D., Principal Investigator, Ajou University School of Medicine
    • Yongchan Lee, M.D., Ph.D., Principal Investigator, Severance Hospital, Yonsei University
    • Sang Yong Seol, M.D., Ph.D., Principal Investigator, Inje University
    • Jeong Seop Moon, M.D., Ph.D., Principal Investigator, Inje University
    • Jong Sun Rew, M.D., Ph.D., Principal Investigator, Chonnam National University Hospital
    • Soo Taek Lee, M.D., Ph.D., Principal Investigator, Chonbuk National University Hospital
    • Chan Kook Park, M.D., Ph.D., Principal Investigator, Chosun University Hospital
    • Jae Gyu Kim, M.D., Ph.D., Principal Investigator, Chung-Ang University Hosptial, Chung-Ang University College of Medicine
    • Sei Jin Youn, M.D., Ph.D., Principal Investigator, Chungbuk National University Hospital
    • Hak Yang Kim, M.D., Ph.D., Principal Investigator, Hallym University Medical Center
    • Byung Chul Yoon, M.D., Ph.D., Principal Investigator, Hanyang University
    • Suck Chei Choi, M.D., Ph.D., Principal Investigator, Wonkwang University Hospital
    • Ki Nam Shim, M.D., Ph.D., Principal Investigator, Ewha Womans University Mokdong Hospital
  • Overall Contact(s)
    • Hyun Chae Jung, M.D., Ph.D., 82-2-2072-0694, snuhirb@gmail.com

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