NCT03998969

Efficacy of DA-5204 on Gastroesophageal Reflux Disease

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Esophageal Disease

Interventions

Type	Name	Description
DRUG	Pantoprazole	Pantoprazole 40mg tablet
DRUG	DA-5204	DA-5204 tablet
DRUG	Placebo	Film-coated tablet manufactured to mimic DA-5204

Timeline

• Start date: 2016-06-01
• Primary completion: 2018-12-11
• Completion: 2018-12-11
• First posted: 2019-06-26
• Last updated: 2019-06-26

Locations

1 site across 1 country: South Korea