A Study to Evaluate the Efficacy and of Stillen Tab. and to Demonstrate the Non-inferiority of Stillen Tab.

April 13, 2021 updated by: Dong-A ST Co., Ltd.

A Multicenter, Active-controlled, Randomized, Double-blind Paralleled-group Clinical Trial to Evaluate the Efficacy of 4-week Treatment With Stillen Tab. in Patients With Acute or Chronic Gastritis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

258

Phase

  • Phase 4

Contacts and Locations

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

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Yonsei University Health System, Severance Hospital, IRB

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

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stillen Tab.
administered three times daily for four weeks
Drug: Stillen Tab.
Active Comparator: Mucosta Tab.
administered three times daily for four weeks
Drug: Mucosta Tab.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement rates of erosive gastritis
Time Frame: 4 weeks

Improvement rates of erosive gastritis (%)

= (improved cases)/(total cases administered) * 100
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing rates of erosive gastritis
Time Frame: 4 weeks

Healing rates of erosive gastritis (%)

= (healed cases)/(total cases administered)*100
4 weeks
Symptoms improved level
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

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

Sponsor

Dong-A ST Co., Ltd.

Investigators

  • 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: 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

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

October 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

March 21, 2013

First Submitted That Met QC Criteria

March 21, 2013

First Posted (Estimate)

March 25, 2013

Study Record Updates

Last Update Posted (Actual)

April 15, 2021

Last Update Submitted That Met QC Criteria

April 13, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA9601_Gas_IV

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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