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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Dong-A ST Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01813812
First received: March 13, 2013
Last updated: March 20, 2013
Last verified: March 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.:

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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
  • The severity of the digestive symptoms (Scale of 1 to 5) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

    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

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 ST 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 Hospital
Principal Investigator: Sei Jin Youn, M.D., Ph.D. Chungbuk National University
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

No publications provided

Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT01813812     History of Changes
Other Study ID Numbers: DA6034_Gas_III (Version 4.3)
Study First Received: March 13, 2013
Last Updated: March 20, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on October 20, 2014