Efficacy of DA-5204 on Gastroesophageal Reflux Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Efficacy of DA-5204 (Stillen 2X®) for Patients With Gastroesophageal Reflux Disease: A Randomized, Double-blind, Placebo-controlled Pilot Study

Conditions
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Esophageal Disease

Intervention / Treatment
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* Drug: Pantoprazole
* Drug: DA-5204
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pantoprazole and DA-5204<br>Pantoprazole 40mg once daily and 'DA-5204' twice daily by mouth, administered for 4 weeks | Drug: Pantoprazole<br>* Pantoprazole 40mg tablet<br>* Other names: Pantoline;Drug: DA-5204<br>* DA-5204 tablet<br>* Other names: Stillen 2X®;|
| Active Comparator: Pantoprazole and placebo<br>Pantoprazole 40mg once daily and 'placebo' twice daily by mouth, administered for 4 weeks | Drug: Pantoprazole<br>* Pantoprazole 40mg tablet<br>* Other names: Pantoline;Drug: Placebo<br>* Film-coated tablet manufactured to mimic DA-5204<br>* Other names: Placebo (for DA-5204);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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] | 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. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroesophageal Reflux, Esophagitis, Peptic