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

Chronic Gastritis Clinical Trial

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02282670
• Other study ID #: DA5204_GR_III
• 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
• 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

Related Conditions & MeSH terms

• Acute Gastritis
• Chronic Gastritis
• Gastritis
• Gastritis, Atrophic

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