NCT01813812

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
492

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Last Updated

March 22, 2013

Status Verified

March 1, 2013

Enrollment Period

2.8 years

First QC Date

March 13, 2013

Last Update Submit

March 20, 2013

Conditions

Acute GastritisChronic Gastritis

Outcome Measures

Primary Outcomes (1)

  • 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

    2 weeks

Secondary Outcomes (2)

  • The number of erosions diagnosed by the gastroscope

    2 weeks

  • The severity of the digestive symptoms (Scale of 1 to 5)

    2 weeks

Study Arms (3)

DA-6034 45mg

EXPERIMENTAL

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

Drug: DA-6034

DA-6034 90mg

EXPERIMENTAL

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

Drug: DA-6034

Rebamipide 300mg

ACTIVE COMPARATOR

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

Drug: Rebamipide 300mg

Interventions

DA-6034DRUG
DA-6034 45mgDA-6034 90mg
Rebamipide 300mgDRUG
Rebamipide 300mg

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with acute gastritis or chronic gastritis
  • or more erosions found in the gastroscope examination
  • Age should be: 20≤age≤75

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

MeSH Terms

Interventions

recoflavonerebamipide

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

82-2-2072-0694snuhirb@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2013

First Posted

March 19, 2013

Study Start

October 1, 2010

Primary Completion

August 1, 2013

Last Updated

March 22, 2013

Record last verified: 2013-03

Locations

KR(1)