Back to resultsA Study to Evaluate the Efficacy and Safety of DA-6034 and to Demonstrate the Non-inferiority of DA-6034
Primary Purpose
Acute Gastritis, Chronic Gastritis
Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DA-6034
Rebamipide 300mg
Sponsored by
About this trial
This is an interventional treatment trial for Acute Gastritis
Eligibility 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
Sites / Locations
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
DA-6034 45mg
DA-6034 90mg
Rebamipide 300mg
Arm Description
two tablets (of DA-6034 45mg) are administered for 2 continuous weeks, three times a day.
two tablets (of DA-6034 90mg) are administered for 2 continuous weeks, three times a day.
two tablets (of Rebamipide 300mg) are administered for 2 continuous weeks, three times a day.
Outcomes
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).
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
The severity of the digestive symptoms (Scale of 1 to 5)
the example of the symptoms are:
epigastralgia, heartburn, acid reflux, nausea, domperidone
Full Information
NCT ID
NCT01813812
First Posted
March 13, 2013
Last Updated
March 20, 2013
Sponsor
Dong-A Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01813812
Brief Title
A Study to Evaluate the Efficacy and Safety of DA-6034 and to Demonstrate the Non-inferiority of DA-6034
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Gastritis, Chronic Gastritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
492 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DA-6034 45mg
Arm Type
Experimental
Arm Description
two tablets (of DA-6034 45mg) are administered for 2 continuous weeks, three times a day.
Arm Title
DA-6034 90mg
Arm Type
Experimental
Arm Description
two tablets (of DA-6034 90mg) are administered for 2 continuous weeks, three times a day.
Arm Title
Rebamipide 300mg
Arm Type
Active Comparator
Arm Description
two tablets (of Rebamipide 300mg) are administered for 2 continuous weeks, three times a day.
Intervention Type
Drug
Intervention Name(s)
DA-6034
Intervention Type
Drug
Intervention Name(s)
Rebamipide 300mg
Primary Outcome Measure Information:
Title
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).
Description
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
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
The number of erosions diagnosed by the gastroscope
Time Frame
2 weeks
Title
The severity of the digestive symptoms (Scale of 1 to 5)
Description
the example of the symptoms are:
epigastralgia, heartburn, acid reflux, nausea, domperidone
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyun Chae Jung, M.D., Ph.D.
Phone
82-2-2072-0694
Email
snuhirb@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun Chae Jung, M.D., Ph.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Soo Heon Park, M.D., Ph.D.
Organizational Affiliation
Catholic University Yeouido St. Mary's Hopspital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seong Woo Jeon, M.D., Ph.D.
Organizational Affiliation
Kyungpook National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sang Woo Lee, M.D.,Ph.D.
Organizational Affiliation
Korea University Ansan Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dong Ho Lee, M.D.,Ph.D.
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kook Lae Lee, M.D., Ph.D.
Organizational Affiliation
SMG-SNU Boramae Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ju Yung Cho, M.D., Ph.D.
Organizational Affiliation
Soonchunhyang University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ki Myeong Lee, M.D., Ph.D.
Organizational Affiliation
Ajou University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yongchan Lee, M.D., Ph.D.
Organizational Affiliation
Severance Hospital, Yonsei University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sang Yong Seol, M.D., Ph.D.
Organizational Affiliation
Inje University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeong Seop Moon, M.D., Ph.D.
Organizational Affiliation
Inje University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jong Sun Rew, M.D., Ph.D.
Organizational Affiliation
Chonnam National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Soo Taek Lee, M.D., Ph.D.
Organizational Affiliation
Chonbuk National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chan Kook Park, M.D., Ph.D.
Organizational Affiliation
Chosun University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jae Gyu Kim, M.D., Ph.D.
Organizational Affiliation
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sei Jin Youn, M.D., Ph.D.
Organizational Affiliation
Chungbuk National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hak Yang Kim, M.D., Ph.D.
Organizational Affiliation
Hallym University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Byung Chul Yoon, M.D., Ph.D.
Organizational Affiliation
Hanyang University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Suck Chei Choi, M.D., Ph.D.
Organizational Affiliation
Wonkwang University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ki Nam Shim, M.D., Ph.D.
Organizational Affiliation
Ewha Womans University Mokdong Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyun Chae Jung, M.D., Ph.D.
Phone
82-2-2072-0694
Email
snuhirb@gmail.com
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of DA-6034 and to Demonstrate the Non-inferiority of DA-6034
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