Efficacy of DA-5204 on Gastroesophageal Reflux Disease

Seoul National University Hospital70 enrolled

Overview

This is a single-center, randomized, double-blind, placebo-controlled clinical Study to evaluate the efficacy of DA-5204 and proton pump inhibitor combination therapy compared with proton pump inhibitor alone therapy in patients with gastroesophageal reflux Disease.

Gastroesophageal reflux disease is a condition in which reflux of stomach contents into the esophagus causes troublesome symptoms, such as heartburn and acid regurgitation. Proton pump inhibitors, as acid suppressor, are the agents recommended as the first-line treatment for gastroesophageal reflux disease. However, approximately 20-30% of patients have insufficient effect on this therapy alone. DA-5204 is a medicine based on Artemisia asiatica 95% ethanol extract. DA-5204 has been administered to treat gastritis and gastric ulcers with antioxidative and cytoprotective actions on gastric mucosal damage. Therefore, we expect DA-5204 to be effective in reflux esophagitis (esophageal mucosal injury).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Esophageal Disease

Interventions

PantoprazoleDRUG

Pantoprazole 40mg tablet

DA-5204DRUG

DA-5204 tablet

PlaceboDRUG

Film-coated tablet manufactured to mimic DA-5204

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age is over 20 years old, under 75 years old, men or women * Patients diagnosed with erosive esophagitis by gastroscopy * Signed the informed consent forms Exclusion Criteria: * Patients who is impossible to receive gastroscopy * Patients with esophageal stricture, esophageal varix, Barrett's esophagus, peptic ulcer or gastrointestinal bleeding * Patients administered with prokinetics, H2 receptor antagonists, proton pump inhibitors, anticholinergic drugs or non-steroid anti-inflammatory drugs prior to study in 4 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

Locations (1)

Seoul National University Bungdang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

Endoscopically effective improvement

A percentage of subjects showed effective improvement of erosive esophagitis (esophageal mucosal injury) by the endoscopy. The definition of "effective improvement" is the subjects showed score changed from 3 to 0, from 2 to 0, or from 3 to 1. \[score 0(LA grade N): normal mucosa, score 1(LA grade M): minimal changes to the mucosa such as erythema, blurring and/or whitish turbidity, score 2(LA grade A): non-confluent mucosal breaks \<5 mm in length, score 3(LA grade B): non-confluent mucosal breaks ≥5 mm in length\]

Time frame: 4 weeks

Endoscopically complete improvement

A percentage of subjects showed complete improvement of erosive esophagitis (esophageal mucosal injury) by the endoscopy. The definition of "complete improvement" is the subjects showed score changed from 3 to 0 or from 2 to 0.

Time frame: 4 weeks

Secondary Outcomes

Symptom improvement

A percentage of subjects showed sufficient improvement of reflux symptom score from Gastroesophageal Reflux Disease Questionnaire (GerdQ). The definition of "sufficient improvement" is the subjects showed ≥50% reduction from the initial sum of scores for GerdQ.

Time frame: 4 weeks

Data from ClinicalTrials.gov

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