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Efficacy of DA-5204 on Gastroesophageal Reflux Disease

Primary Purpose

Esophageal Disease

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pantoprazole
DA-5204
Placebo
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Disease focused on measuring Gastroesophageal Reflux, Esophagitis, Peptic

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bungdang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pantoprazole and DA-5204

Pantoprazole and placebo

Arm Description

Pantoprazole 40mg once daily and 'DA-5204' twice daily by mouth, administered for 4 weeks

Pantoprazole 40mg once daily and 'placebo' twice daily by mouth, administered for 4 weeks

Outcomes

Primary Outcome Measures

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]
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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 25, 2019
Last Updated
June 25, 2019
Sponsor
Seoul National University Hospital
Collaborators
Dong-A ST Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03998969
Brief Title
Efficacy of DA-5204 on Gastroesophageal Reflux Disease
Official Title
Efficacy of DA-5204 (Stillen 2X®) for Patients With Gastroesophageal Reflux Disease: A Randomized, Double-blind, Placebo-controlled Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
December 11, 2018 (Actual)
Study Completion Date
December 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Dong-A ST Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Disease
Keywords
Gastroesophageal Reflux, Esophagitis, Peptic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pantoprazole and DA-5204
Arm Type
Experimental
Arm Description
Pantoprazole 40mg once daily and 'DA-5204' twice daily by mouth, administered for 4 weeks
Arm Title
Pantoprazole and placebo
Arm Type
Active Comparator
Arm Description
Pantoprazole 40mg once daily and 'placebo' twice daily by mouth, administered for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Pantoprazole
Other Intervention Name(s)
Pantoline
Intervention Description
Pantoprazole 40mg tablet
Intervention Type
Drug
Intervention Name(s)
DA-5204
Other Intervention Name(s)
Stillen 2X®
Intervention Description
DA-5204 tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo (for DA-5204)
Intervention Description
Film-coated tablet manufactured to mimic DA-5204
Primary Outcome Measure Information:
Title
Endoscopically effective improvement
Description
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
Title
Endoscopically complete improvement
Description
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
Secondary Outcome Measure Information:
Title
Symptom improvement
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong Ho Lee, MD, PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bungdang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of DA-5204 on Gastroesophageal Reflux Disease

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