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Clinical Trial Details — Status: Unknown status

Administrative data

NCT number NCT02282670
Other study ID # DA5204_GR_III
Secondary ID
Status Unknown status
Phase Phase 3
First received October 28, 2014
Last updated October 31, 2014
Start date April 2014
Est. completion date November 2014

Study information

Verified date October 2014
Source Dong-A ST Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Unknown status
Enrollment 434
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender All
Age group 20 Years to 75 Years
Eligibility 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

Study Design


Intervention

Drug:
DA-5204

Stillen tab.


Locations

Country Name City State
Korea, Republic of Seoul National Universtiy, Bundang Hospital, IRB Seongnam Gyeonggi-do

Sponsors (1)

Lead Sponsor Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. 2 weeks
Secondary 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)]. 2 weeks
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