Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Dong-A ST Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pantoprazole and DA-5204 | Experimental | Pantoprazole 40mg once daily and 'DA-5204' twice daily by mouth, administered for 4 weeks |
|
| Pantoprazole and placebo | Active Comparator | Pantoprazole 40mg once daily and 'placebo' twice daily by mouth, administered for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pantoprazole | Drug | Pantoprazole 40mg tablet |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dong Ho Lee, MD, PhD | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bungdang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005764 | Gastroesophageal Reflux |
| D004942 | Esophagitis, Peptic |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077402 | Pantoprazole |
| C000711370 | DA-5204 |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| DA-5204 | Drug | DA-5204 tablet |
|
|
| Placebo | Drug | Film-coated tablet manufactured to mimic DA-5204 |
|
|
| D004941 | Esophagitis |
| D005759 | Gastroenteritis |
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D013272 | Stomach Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |