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A Study to Evaluate the Efficacy and Safety of DA-5204

Primary Purpose

Acute Gastritis, Chronic Gastritis

Status

Unknown status

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

DA-5204

Stillen 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 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

Sites / Locations

Seoul National Universtiy, Bundang Hospital, IRB

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DA-5204

Stillen tab.

Arm Description

DA-5204 administered two times daily for two weeks

Stillen tab. administered three times daily for two weeks

Outcomes

Primary Outcome Measures

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]

Secondary Outcome Measures

A percentage of completely cured subject after a treatment

The definition of "completely cured" is the subjects with no erosions, in other words, 0 erosion found at stomach by the endoscopy.

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

The definition of "moderate improvement" is the subjects showed reduction ratio of score changed from 50% to 75%. And, "singnificant improvement" means the subjects showed reduction ratio of score changed 75% or more. Reduction ratio of score is calculated as [1-(total score of 7 days before termination of treatment)/(total score of 7 days before treatment)].

Full Information

NCT ID

NCT02282670

First Posted

October 28, 2014

Last Updated

October 31, 2014

Sponsor

Dong-A ST Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02282670

Brief Title

A Study to Evaluate the Efficacy and Safety of DA-5204

Official Title

A Phase III Clinical Trial 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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Unknown status

Study Start Date

April 2014 (undefined)

Primary Completion Date

November 2014 (Anticipated)

Study Completion Date

November 2014 (Anticipated)

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 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.

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 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

434 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DA-5204

Arm Type

Experimental

Arm Description

DA-5204 administered two times daily for two weeks

Arm Title

Stillen tab.

Arm Type

Active Comparator

Arm Description

Stillen tab. administered three times daily for two weeks

Intervention Type

Drug

Intervention Name(s)

DA-5204

Intervention Type

Drug

Intervention Name(s)

Stillen tab.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

A percentage of completely cured subject after a treatment

Description

The definition of "completely cured" is the subjects with no erosions, in other words, 0 erosion found at stomach by the endoscopy.

Time Frame

2 weeks

Title

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

Description

Time Frame

2 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 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

Overall Study Officials: