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

Primary Purpose

Acute Gastritis, Chronic Gastritis

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Stillen Tab.

Mucosta Tab.

About this trial

This is an interventional treatment trial for Acute Gastritis

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Yonsei University Health System, Severance Hospital, IRB

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stillen Tab.

Mucosta Tab.

Arm Description

administered three times daily for four weeks

Outcomes

Primary Outcome Measures

Improvement rates of erosive gastritis

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

Secondary Outcome Measures

Healing rates of erosive gastritis

Healing rates of erosive gastritis (%) = (healed cases)/(total cases administered)*100

Symptoms improved level

Full Information

NCT ID

NCT01817556

First Posted

March 21, 2013

Last Updated

April 13, 2021

Sponsor

Dong-A ST Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01817556

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

October 2013 (Actual)

Study Completion Date

October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dong-A ST Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Gastritis, Chronic Gastritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

258 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Stillen Tab.

Arm Type

Experimental

Arm Description

administered three times daily for four weeks

Arm Title

Mucosta Tab.

Arm Type

Active Comparator

Arm Description

administered three times daily for four weeks

Intervention Type

Drug

Intervention Name(s)

Stillen Tab.

Intervention Type

Drug

Intervention Name(s)

Mucosta Tab.

Primary Outcome Measure Information:

Title

Improvement rates of erosive gastritis

Description

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

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Healing rates of erosive gastritis

Description

Healing rates of erosive gastritis (%) = (healed cases)/(total cases administered)*100

Time Frame

4 weeks

Title

Symptoms improved level

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: