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

NCT ID: NCT01813812

Last Updated: 2013-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

492 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Gastritis Chronic Gastritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DA-6034 45mg

two tablets (of DA-6034 45mg) are administered for 2 continuous weeks, three times a day.

Group Type EXPERIMENTAL

DA-6034

Intervention Type DRUG

DA-6034 90mg

two tablets (of DA-6034 90mg) are administered for 2 continuous weeks, three times a day.

Group Type EXPERIMENTAL

DA-6034

Intervention Type DRUG

Rebamipide 300mg

two tablets (of Rebamipide 300mg) are administered for 2 continuous weeks, three times a day.

Group Type ACTIVE_COMPARATOR

Rebamipide 300mg

Intervention Type DRUG

Interventions

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DA-6034

Intervention Type DRUG

Rebamipide 300mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dong-A Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hyun Chae Jung, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Soo Heon Park, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Catholic University Yeouido St. Mary's Hopspital

Seong Woo Jeon, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Kyungpook National University Hospital

Sang Woo Lee, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Korea University Ansan Hospital

Dong Ho Lee, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Kook Lae Lee, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

SMG-SNU Boramae Medical Center

Ju Yung Cho, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Soonchunhyang University Hospital

Ki Myeong Lee, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Ajou University School of Medicine

Yongchan Lee, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital, Yonsei University

Sang Yong Seol, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Inje University

Jeong Seop Moon, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Inje University

Jong Sun Rew, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Chonnam National University Hospital

Soo Taek Lee, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Chonbuk National University Hospital

Chan Kook Park, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Chosun University Hospital

Jae Gyu Kim, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Sei Jin Youn, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Chungbuk National University Hospital

Hak Yang Kim, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Hallym University Medical Center

Byung Chul Yoon, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Hanyang University

Suck Chei Choi, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Wonkwang University Hospital

Ki Nam Shim, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Ewha Womans University Mokdong Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hyun Chae Jung, M.D., Ph.D.

Role: CONTACT

82-2-2072-0694

Facility Contacts

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Hyun Chae Jung, M.D., Ph.D.

Role: primary

82-2-2072-0694

Other Identifiers

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DA6034_Gas_III (Version 4.3)

Identifier Type: -

Identifier Source: org_study_id

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