Esophageal DiseasePhase 3NCT03998969
Efficacy of DA-5204 on Gastroesophageal Reflux Disease
A Phase 3 study testing Pantoprazole and DA-5204 in people with Esophageal Disease, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Esophageal Disease
- What is being tested?
- Pantoprazole and DA-5204
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2016to 11 Dec 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bungdang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: Efficacy of DA-5204 (Stillen 2X®) for Patients With Gastroesophageal Reflux Disease: A Randomized, Double-blind, Placebo-controlled Pilot Study
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.
Read the 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).
- Conditions
- Esophageal Disease
- Being tested
- Pantoprazole, DA-5204, Placebo
- Keywords
- Gastroesophageal Reflux, Esophagitis, Peptic
- Medical subject headings
- Esophageal Diseases, Gastroesophageal Reflux, Esophagitis, Peptic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PantoprazoleDrug
Also called Pantoline
Pantoprazole 40mg tablet
DA-5204Drug
Also called Stillen 2X®
DA-5204 tablet
PlaceboDrug
Also called Placebo (for DA-5204)
Film-coated tablet manufactured to mimic DA-5204
| Study group | Role | What they receive |
|---|---|---|
| Pantoprazole and DA-5204 | Experimental | Pantoprazole 40mg once daily and 'DA-5204' twice daily by mouth, administered for 4 weeks Receives: Drug: Pantoprazole; Drug: DA-5204 |
| Pantoprazole and placebo | Active comparator | Pantoprazole 40mg once daily and 'placebo' twice daily by mouth, administered for 4 weeks Receives: Drug: Pantoprazole; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: 4 weeks
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.
Measured: 4 weeks
Secondary outcomes (1)
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start1 Jun 2016
- Primary completion11 Dec 2018
- Study completion11 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dong-A ST Co., Ltd.
- Responsible party
- Principal investigator, Dong Ho Lee, Seoul National University Hospital
- Investigators
- Dong Ho Lee, MD, PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998969
- Sponsor's protocol ID
- SNUBH-DHLDA5204
- Status last verified
- Jun 2019
- First submitted
- 25 Jun 2019
- Last updated
- 26 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of DA-5204 (Stillen 2X®) for Patients With Gastroesophageal Reflux Disease: A Randomized, Double-blind, Placebo-controlled Pilot Study
- ClinicalTrials.gov ID
- NCT03998969
- Acronym / sponsor ID
- SNUBH-DHLDA5204
- Conditions
- Esophageal Disease
- Keywords
- Gastroesophageal Reflux, Esophagitis, Peptic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Dong-A ST Co., Ltd.
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 11 Dec 2018 (actual)
- Study completion
- 11 Dec 2018 (actual)
- First posted
- 26 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pantoprazole and DA-5204 | Experimental | Drug: Pantoprazole, Drug: DA-5204Pantoprazole 40mg once daily and 'DA-5204' twice daily by mouth, administered for 4 weeks |
| Pantoprazole and placebo | Active comparator | Drug: Pantoprazole, Drug: PlaceboPantoprazole 40mg once daily and 'placebo' twice daily by mouth, administered for 4 weeks |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PantoprazoleAlso: PantolinePantoprazole 40mg tablet | Drug | Pantoprazole and DA-5204, Pantoprazole and placebo |
| DA-5204Also: Stillen 2X®DA-5204 tablet | Drug | Pantoprazole and DA-5204 |
| PlaceboAlso: Placebo (for DA-5204)Film-coated tablet manufactured to mimic DA-5204 | Drug | Pantoprazole and placebo |
Primary outcome
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]
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.
1 secondary outcome
Symptom improvement
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong Ho Lee, MD, PhD principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pantoprazole and DA-5204 in people with Esophageal Disease, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endoscopically effective improvement (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2019.