Overview

This trial is active, not recruiting.

Conditions acute gastritis, chronic gastritis
Treatments da-5204, stillen tab.
Phase phase 3
Sponsor Dong-A ST Co., Ltd.
Start date April 2014
End date November 2014
Trial size 434 participants
Trial identifier NCT02282670, DA5204_GR_III

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
DA-5204 administered two times daily for two weeks
da-5204
(Active Comparator)
Stillen tab. administered three times daily for two weeks
stillen tab.

Primary Outcomes

Measure
A percentage of subjects showed moderate or significant improvement of stomach erosions by the endoscopy.
time frame: 2 weeks

Secondary Outcomes

Measure
A percentage of completely cured subject after a treatment
time frame: 2 weeks
A percentage of subjects showed morderate or significant improvement of gastric symptom rating scale.
time frame: 2 weeks

Eligibility Criteria

Male or female participants from 20 years up to 75 years old.

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

Additional Information

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
Principal investigator Dong Ho Lee, M.D., Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Dong-A ST Co., Ltd..