Skip to main content
OpenTrials
Completed

NCT Number: NCT03998969

Efficacy of DA-5204 on Gastroesophageal Reflux Disease

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Bungdang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pantoprazole

Drug

Pantoprazole 40mg tablet

Other names: Pantoline

DA-5204

Drug

DA-5204 tablet

Other names: Stillen 2X®

Placebo

Drug

Film-coated tablet manufactured to mimic DA-5204

Other names: Placebo (for DA-5204)

Primary outcomes

  1. Endoscopically effective improvement

    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]

  2. Endoscopically complete improvement

    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.

Secondary outcomes

  1. Symptom improvement

    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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Dong-A ST Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 26, 2019
Registry last updated
Jun 26, 2019

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.

Published trials that share one or more normalized conditions with this study.