Efficacy of DA-5204 on Gastroesophageal Reflux Disease
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pantoprazole and DA-5204 Pantoprazole 40mg once daily and 'DA-5204' twice daily by mouth, administered for 4 weeks |
Drug: Pantoprazole
Pantoprazole 40mg tablet
Other Names:
Drug: DA-5204
DA-5204 tablet
Other Names:
|
| Active Comparator: Pantoprazole and placebo Pantoprazole 40mg once daily and 'placebo' twice daily by mouth, administered for 4 weeks |
Drug: Pantoprazole
Pantoprazole 40mg tablet
Other Names:
Drug: Placebo
Film-coated tablet manufactured to mimic DA-5204
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Endoscopically effective improvement [4 weeks]
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]
- Endoscopically complete improvement [4 weeks]
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.
Secondary Outcome Measures
- Symptom improvement [4 weeks]
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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seoul National University Bungdang Hospital | Seongnam-si | Gyeonggi-do | Korea, Republic of | 13620 |
Sponsors and Collaborators
- Seoul National University Hospital
- Dong-A ST Co., Ltd.
Investigators
- Principal Investigator: Dong Ho Lee, MD, PhD, Seoul National University Bundang Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SNUBH-DHLDA5204