Efficacy of DA-5204 on Gastroesophageal Reflux Disease

Last updated: June 25, 2019
Sponsor: Seoul National University Hospital
Overall Status: Completed

Phase

3

Condition

Heartburn (Pediatric)

Esophageal Disorders

Gastrointestinal Diseases And Disorders

Treatment

N/A

Clinical Study ID

NCT03998969
SNUBH-DHLDA5204
  • Ages 20-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Patients who is impossible to receive gastroscopy

  • Patients with esophageal stricture, esophageal varix, Barrett's esophagus, pepticulcer or gastrointestinal bleeding

  • Patients administered with prokinetics, H2 receptor antagonists, proton pumpinhibitors, anticholinergic drugs or non-steroid anti-inflammatory drugs prior tostudy 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 orendocrine system primary disease

  • Patients with neuropsychiatric disorder, alcoholism, or drug abuse

  • Patients taking other investigational drugs or participating in other clinical studiesin 4 weeks.

  • Women either pregnant or breast feeding

Study Design

Total Participants: 70
Study Start date:
June 01, 2016
Estimated Completion Date:
December 11, 2018

Study 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).

Connect with a study center

  • Seoul National University Bungdang Hospital

    Seongnam-si, Gyeonggi-do 13620
    Korea, Republic of

    Site Not Available

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