NCT01817556

Brief Summary

This is a multicenter, active-controlled, randomized, double-blinded, paralleled group clinical study to evaluate the efficacy of 4-week treatment with Stillen tab. in patients with acute or chronic gastritis. Subject will receive Stillen tab or Mucosta tab., three times a day for four weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
258

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 25, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

April 15, 2021

Status Verified

April 1, 2021

Enrollment Period

1 year

First QC Date

March 21, 2013

Last Update Submit

April 13, 2021

Conditions

Acute GastritisChronic Gastritis

Outcome Measures

Primary Outcomes (1)

  • Improvement rates of erosive gastritis

    Improvement rates of erosive gastritis (%) = (improved cases)/(total cases administered) \* 100

    4 weeks

Secondary Outcomes (2)

  • Healing rates of erosive gastritis

    4 weeks

  • Symptoms improved level

    4 weeks

Study Arms (2)

Stillen Tab.

EXPERIMENTAL

administered three times daily for four weeks

Drug: Stillen Tab.

Mucosta Tab.

ACTIVE COMPARATOR

administered three times daily for four weeks

Drug: Mucosta Tab.

Interventions

Stillen Tab.DRUG
Stillen Tab.
Mucosta Tab.DRUG
Mucosta 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 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
  • Women either pregnant or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University Health System, Severance Hospital, IRB

Seoul, 120-752, South Korea

Location

MeSH Terms

Interventions

DA 9601

Study Officials

  • Yong Chan Lee, M.D., Ph.D.

    Yonsei University, Severance Hospital of Korea

    PRINCIPAL INVESTIGATOR

  • Jin Il Kim, M.D., Ph.D.

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

    PRINCIPAL INVESTIGATOR

  • Kwang Ro Joo, M.D., Ph.D.

    Kyung Hee University Gangdong Hospital of Korea

    PRINCIPAL INVESTIGATOR

  • Dong Il Park, M.D., Ph.D.

    Kangbuk Samsung Hospital of Korea

    PRINCIPAL INVESTIGATOR

  • In Kyung Sung, M.D.,Ph.D.

    Konkuk University Hospital of Korea

    PRINCIPAL INVESTIGATOR

  • Kyu Chan Huh, M.D., Ph.D.

    Konyang University Hospital of Korea

    PRINCIPAL INVESTIGATOR

  • Jung Il Suh, M.D., Ph.D.

    Dongguk University Gyeongju Hospital of Korea

    PRINCIPAL INVESTIGATOR

  • Su Jin Hong, M.D., Ph.D.

    Soon Chun Hyang University Bucheon Hospital of Korea

    PRINCIPAL INVESTIGATOR

  • Jin Heung Kim, M.D., Ph.D.

    Ajou University Hospital of Korea

    PRINCIPAL INVESTIGATOR

  • Dae Hwan Kang, M.D., Ph.D.

    Pusan National University Yangsan Hospital of Korea

    PRINCIPAL INVESTIGATOR

  • Tae Joo Jeon, M.D., Ph.D.

    Inje University Sanggye Paik Hospital of Korea

    PRINCIPAL INVESTIGATOR

  • Tea Oh Kim, M.D., Ph.D.

    Inje University Haeundae Paik Hospital of Korea

    PRINCIPAL INVESTIGATOR

  • Hyun Yong Jeong, M.D., Ph.D.

    Chungnam National Unviersity Hospital of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
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 21, 2013

First Posted

March 25, 2013

Study Start

October 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

April 15, 2021

Record last verified: 2021-04

Locations

KR(1)