Efficacy of DA-5204 on Gastroesophageal Reflux Disease

Esophageal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03998969
• Other study ID #: SNUBH-DHLDA5204
• Status: Completed
• Phase: Phase 3
• Start date: June 1, 2016
• Est. completion date: December 11, 2018

Study information

• Verified date: June 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 11, 2018
• Est. primary completion date: December 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Disease
• Esophageal Diseases
• Esophagitis, Peptic
• Gastroesophageal Reflux

Intervention

Drug:
• Pantoprazole
Pantoprazole 40mg tablet
• DA-5204
DA-5204 tablet
• Placebo
Film-coated tablet manufactured to mimic DA-5204

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bungdang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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