NCT02282670

Brief Summary

This is a multicenter, active-controlled, randomized, double-blinded, paralleled group clinical study to evaluate the efficacy and safety of DA-5204 and to demonstrate the non-inferiority of DA-5204 compared with Stillen® tab. in patients with acute or chronic gastritis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
434

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2014

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2014

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2014

Completed
Last Updated

November 4, 2014

Status Verified

October 1, 2014

Enrollment Period

7 months

First QC Date

October 28, 2014

Last Update Submit

October 31, 2014

Conditions

Acute GastritisChronic Gastritis

Outcome Measures

Primary Outcomes (1)

  • A percentage of subjects showed moderate or significant improvement of stomach erosions by the endoscopy.

    The definition of "moderate improvement" is the subjects showed score changed from 4 to 1 or from 2 to 1. And, "significant improvement" means the subject showed score changed from 4 to 1 or from 3 to 1. \[score 1(normal) : no erosion, score 2(mild) : 1-2 erosions, score 3(moderate) : 3-5 erosions, score 4(severe) : 6 or more erosions\]

    2 weeks

Secondary Outcomes (2)

  • A percentage of completely cured subject after a treatment

    2 weeks

  • A percentage of subjects showed morderate or significant improvement of gastric symptom rating scale.

    2 weeks

Study Arms (2)

DA-5204

EXPERIMENTAL

DA-5204 administered two times daily for two weeks

Drug: DA-5204

Stillen tab.

ACTIVE COMPARATOR

Stillen tab. administered three times daily for two weeks

Drug: Stillen tab.

Interventions

DA-5204DRUG
DA-5204
Stillen tab.DRUG
Stillen tab.

Eligibility Criteria

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

You may qualify if:

  • Age is over 20 years old, under 75 years old, men or women
  • Patients diagnosed with acute or chronic gastritis by gastroscopy
  • Patients with one or more erosions found by gastroscopy
  • Signed the informed consent forms

You may not qualify if:

  • Patients who is impossible to receive gastroscopy
  • Patients with peptic ulcer and gastroesophageal reflux disease
  • Patients administered with prokinetics, H2 receptor antagonists, proton pump inhibitors, anticholinergic drugs or non-steroid anti-inflammatory drugs prior to study in 2 weeks
  • Patients with surgery related to gastroesophageal
  • Patients with Zollinger-Ellison syndrome
  • Patients with any kind of malignant tumor
  • Patients administered with anti-thrombotic drugs
  • Patients with significant cardiovascular, pulmonary, heptic, renal, hemopoietic or endocrine system primary disease
  • Patients with neuropsychiatric disorder, alcoholism, or drug abuse
  • Patients taking other investigational drugs or participating in other clinical studies in 4 weeks.
  • Women either pregnant or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National Universtiy, Bundang Hospital, IRB

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Related Publications (1)

  • Choi YJ, Lee DH, Choi MG, Lee SJ, Kim SK, Song GA, Rhee PL, Jung HY, Kang DH, Lee YC, Lee SH, Choi SC, Shim KN, Seol SY, Moon JS, Shin YW, Kim HS, Lee ST, Cho JW, Choi EK, Lee OY, Jang JS. Evaluation of the Efficacy and Safety of DA-9601 versus Its New Formulation, DA-5204, in Patients with Gastritis: Phase III, Randomized, Double-Blind, Non-Inferiority Study. J Korean Med Sci. 2017 Nov;32(11):1807-1813. doi: 10.3346/jkms.2017.32.11.1807.

    PMID: 28960033DERIVED

MeSH Terms

Interventions

DA-5204DA 9601

Study Officials

  • Dong Ho Lee, M.D., Ph.D.

    Seoul National University Bundang Hospital of Korea

    PRINCIPAL INVESTIGATOR

  • Myung Gyu Choi, M.D., Ph.D.

    The Catholic University, Seoul St. Mary's Hospital of Korea

    PRINCIPAL INVESTIGATOR

  • Sung Joon Lee, M.D., Ph.D.

    Kangwon National University Hospital of Korea

    PRINCIPAL INVESTIGATOR

  • Sung Kuk Kim, M.D., Ph.D.

    Kyungbuk National University Hospital of Korea

    PRINCIPAL INVESTIGATOR

  • Geun Am Song, M.D., Ph.D.

    Pusan National Universtiy Hospital of Korea

    PRINCIPAL INVESTIGATOR

  • Poong Lyeol Lee, M.D., Ph.D.

    Samsung Medical Center of Korea

    PRINCIPAL INVESTIGATOR

  • Hwoon Yong Jung, M.D., Ph.D.

    Asan Medical Center of Korea

    PRINCIPAL INVESTIGATOR

  • Dae Hwan Kang, M.D., Ph.D.

    Pusan National University Yangsan Hospital of Korea

    PRINCIPAL INVESTIGATOR

  • Yong Chan Lee, M.D., Ph.D.

    Yonsei University, Severance Hospital of Korea

    PRINCIPAL INVESTIGATOR

  • Si Hyung Lee, M.D., Ph.D.

    Yeungnam University Hospital of Korea

    PRINCIPAL INVESTIGATOR

  • Suck Chei Choi, M.D., Ph.D.

    Wonkwang University Hospital of Korea

    PRINCIPAL INVESTIGATOR

  • Gi Nam Sim, M.D., Ph.D.

    Ewha Womans University Medical Center of Korea

    PRINCIPAL INVESTIGATOR

  • Sang Young Seoul, M.D., Ph.D.

    Inje University Busan Paik Hospital of Korea

    PRINCIPAL INVESTIGATOR

  • Jeong Seop Moon, M.D., Ph.D.

    Inje University Seoul Paik Hospital of Korea

    PRINCIPAL INVESTIGATOR

  • Yong Woon Shin, M.D., Ph.D.

    Inha University Hospital of Korea

    PRINCIPAL INVESTIGATOR

  • Hyen Soo Kim, M.D., Ph.D.

    Chonnam National Universtiy Hospital of Korea

    PRINCIPAL INVESTIGATOR

  • Soo Teik Lee, M.D., Ph.D.

    Chonbuk National Universtiy Hospital of Korea

    PRINCIPAL INVESTIGATOR

  • Jin Woong Cho, M.D., Ph.D.

    The Presbyterian medical center in Jeonju of Korea

    PRINCIPAL INVESTIGATOR

  • Eun Kwang Choi, M.D., Ph.D.

    Jeju National Universtiy Hospital of Korea

    PRINCIPAL INVESTIGATOR

  • Soon Man Yoon, M.D., Ph.D.

    Chungbuk National University Hospital of Korea

    PRINCIPAL INVESTIGATOR

  • Oh Young Lee, M.D., Ph.D.

    Hanyang Universtiy Hospital of Korea

    PRINCIPAL INVESTIGATOR

  • Jin Seok Jang, M.D., Ph.D.

    Dong-A University Hospital of Korea

    PRINCIPAL INVESTIGATOR

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

October 28, 2014

First Posted

November 4, 2014

Study Start

April 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

November 4, 2014

Record last verified: 2014-10

Locations

KR(1)