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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.
Verified March 2013 by Dong-A Pharmaceutical Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Dong-A Pharmaceutical 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 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 ] [ 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
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 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 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 Pharmaceutical 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
Gastritis, Atrophic
Acute Disease
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Disease Attributes
Pathologic Processes
Rebamipide
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014