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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by Dong-A ST Co., Ltd. ( Dong-A Pharmaceutical Co., Ltd. ).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01813812
First Posted: March 19, 2013
Last Update Posted: March 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dong-A ST Co., Ltd. ( Dong-A Pharmaceutical Co., Ltd. )
  Purpose
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.

Condition Intervention Phase
Acute Gastritis Chronic Gastritis Drug: DA-6034 Drug: Rebamipide 300mg Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Dong-A ST Co., Ltd. ( Dong-A Pharmaceutical Co., Ltd. ):

Primary Outcome 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 Outcome 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



Estimated Enrollment: 492
Study Start Date: October 2010
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DA-6034 45mg
two tablets (of DA-6034 45mg) are administered for 2 continuous weeks, three times a day.
Drug: DA-6034
Experimental: DA-6034 90mg
two tablets (of DA-6034 90mg) are administered for 2 continuous weeks, three times a day.
Drug: DA-6034
Active Comparator: Rebamipide 300mg
two tablets (of Rebamipide 300mg) are administered for 2 continuous weeks, three times a day.
Drug: Rebamipide 300mg

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01813812


Contacts
Contact: Hyun Chae Jung, M.D., Ph.D. 82-2-2072-0694 snuhirb@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Hyun Chae Jung, M.D., Ph.D.    82-2-2072-0694    snuhirb@gmail.com   
Sponsors and Collaborators
Dong-A Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Hyun Chae Jung, M.D., Ph.D. Seoul National University Hospital
Principal Investigator: Soo Heon Park, M.D., Ph.D. Catholic University Yeouido St. Mary's Hopspital
Principal Investigator: Seong Woo Jeon, M.D., Ph.D. Kyungpook National University
Principal Investigator: Sang Woo Lee, M.D.,Ph.D. Korea University
Principal Investigator: Dong Ho Lee, M.D.,Ph.D. Seoul National University Bundang Hospital
Principal Investigator: Kook Lae Lee, M.D., Ph.D. SMG-SNU Boramae Medical Center
Principal Investigator: Ju Yung Cho, M.D., Ph.D. Soonchunhyang University Hospital
Principal Investigator: Ki Myeong Lee, M.D., Ph.D. Ajou University School of Medicine
Principal Investigator: Yongchan Lee, M.D., Ph.D. Severance Hospital, Yonsei University
Principal Investigator: Sang Yong Seol, M.D., Ph.D. Inje University
Principal Investigator: Jeong Seop Moon, M.D., Ph.D. Inje University
Principal Investigator: Jong Sun Rew, M.D., Ph.D. Chonnam National University Hospital
Principal Investigator: Soo Taek Lee, M.D., Ph.D. Chonbuk National University Hospital
Principal Investigator: Chan Kook Park, M.D., Ph.D. Chosun University Hospital
Principal Investigator: Jae Gyu Kim, M.D., Ph.D. Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Principal Investigator: Sei Jin Youn, M.D., Ph.D. Chungbuk National University Hospital
Principal Investigator: Hak Yang Kim, M.D., Ph.D. Hallym University Medical Center
Principal Investigator: Byung Chul Yoon, M.D., Ph.D. Hanyang University
Principal Investigator: Suck Chei Choi, M.D., Ph.D. Wonkwang University Hospital
Principal Investigator: Ki Nam Shim, M.D., Ph.D. Ewha Womans University Mokdong Hospital
  More Information

Responsible Party: Dong-A Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01813812     History of Changes
Other Study ID Numbers: DA6034_Gas_III (Version 4.3)
First Submitted: March 13, 2013
First Posted: March 19, 2013
Last Update Posted: March 22, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Gastritis
Gastritis, Atrophic
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Rebamipide
Anti-Ulcer Agents
Gastrointestinal Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Enzyme Inhibitors