Seoul National University Bungdang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
NCT Number: NCT03998969
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.
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Notify Me20 year–75 year
All sexes
Interventional
Phase 3
Seongnam-si, Gyeonggi-do, 13620, South Korea
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pantoprazole 40mg tablet
Other names: Pantoline
DA-5204 tablet
Other names: Stillen 2X®
Film-coated tablet manufactured to mimic DA-5204
Other names: Placebo (for DA-5204)
Time frame: 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]
Time frame: 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.
Time frame: 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.
Seoul National University Hospital
Other
Efficacy of DA-5204 (Stillen 2X®) for Patients With Gastroesophageal Reflux Disease: A Randomized, Double-blind, Placebo-controlled Pilot Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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