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

March 20, 2013 updated by: Dong-A Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
492

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Hyun Chae Jung, M.D., Ph.D.
  • Phone Number: 82-2-2072-0694
  • Email: snuhirb@gmail.com

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Recruiting
        • Seoul National University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The number of erosions diagnosed by the gastroscope
Time Frame: 2 weeks
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
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dong-A Pharmaceutical Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 Hospital
  • Principal Investigator: Sang Woo Lee, M.D.,Ph.D., Korea University Ansan Hospital
  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2010

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DA6034_Gas_III (Version 4.3)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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