Gastro Esophageal RefluxPhase 4NCT06430047
Efficacy and Safety of EsoDuo®
A Phase 4 study testing EsoDuo® Tablet in people with Gastro Esophageal Reflux, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
Clinical Trial to Evaluate the Effects of EsoDuo® in Controlling Reflux Symptoms Related to the Acid Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Gastro Esophageal Reflux
- What is being tested?
- EsoDuo® Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Nov 2022to May 2025
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female aged ≥ 19 years
- Patients diagnosed with non-erosive reflux disease or mild erosive reflux disease
- Episode of heartburn the GERD symptom(either heartburn or gastric acid reflux)
Who cannot join
- Surgery history on stomach or esophagus
- Barrett's esophagus (over 3cm), esophageal varices, esophageal stricture, esophageal achalasia, eosinophilic esophagitis, and primary motility disorders
- Patients diagnosed with Grade C or Grade D according to the LA Classification system during upper gastrointestinal endoscopy
- Patients with a history of malignancy within the past 5 years prior to the screening visit (Visit 1)
- Patients who have taken prohibited concomitant medications within 14 days prior to the screening visit or require continuous administration of prohibited medications during the trial period.
- Clinically significant Abnormal Lab test
- Pregnant woman, Breastfeeding woman.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul
Hwoon-Yong Jung, PhD
82+2-3010-3197, hwoonymd@gmail.com
About this study
Official title: The Role of an EsoDuo® to Control Reflux Symptoms Related to the Acid; a Multicenter, Open-labeled, Phase 4 Study [RACER Study]
Clinical Trial to Evaluate the Effects of EsoDuo® in Controlling Reflux Symptoms Related to the Acid
Read the detailed description
The Role of an EsoDuo® to Control Reflux Symptoms Related to the Acid; a Multicenter, Open-labeled, Phase 4 Study [RACER Study]
- Conditions
- Gastro Esophageal Reflux
- Being tested
- EsoDuo® Tablet
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsoDuo® TabletDrug
QD, PO
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Not described Receives: Drug: EsoDuo® Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time taken to control the symptoms of GERD
the symptoms of GERD : heartburn or acid reflux
Measured: 2 weeks after the clinical trial participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start25 Nov 2022
- Primary completionJan 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro Esophageal RefluxStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hwoon-Yong Jung, M.D, PhD, Principal investigator, Asan Medical Cental of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06430047
- Sponsor's protocol ID
- B73_02GERD2107
- Status last verified
- May 2024
- First submitted
- 21 May 2024
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of an EsoDuo® to Control Reflux Symptoms Related to the Acid; a Multicenter, Open-labeled, Phase 4 Study [RACER Study]
- ClinicalTrials.gov ID
- NCT06430047
- Acronym / sponsor ID
- B73_02GERD2107
- Conditions
- Gastro Esophageal Reflux
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2022 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 28 May 2024 (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.
Clinical Trial to Evaluate the Effects of EsoDuo® in Controlling Reflux Symptoms Related to the Acid
Detailed description
The Role of an EsoDuo® to Control Reflux Symptoms Related to the Acid; a Multicenter, Open-labeled, Phase 4 Study [RACER Study]
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: EsoDuo® Tablet |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or Female aged ≥ 19 years
- Patients diagnosed with non-erosive reflux disease or mild erosive reflux disease
- Episode of heartburn the GERD symptom(either heartburn or gastric acid reflux)
Key exclusion criteria (7 listed)
- Surgery history on stomach or esophagus
- Barrett's esophagus (over 3cm), esophageal varices, esophageal stricture, esophageal achalasia, eosinophilic esophagitis, and primary motility disorders
- Patients diagnosed with Grade C or Grade D according to the LA Classification system during upper gastrointestinal endoscopy
- Patients with a history of malignancy within the past 5 years prior to the screening visit (Visit 1)
- Patients who have taken prohibited concomitant medications within 14 days prior to the screening visit or require continuous administration of prohibited medications during the trial period.
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 |
|---|---|---|
| EsoDuo® TabletQD, PO | Drug | Experimental Group |
Primary outcome
The time taken to control the symptoms of GERD
Time frame: 2 weeks after the clinical trial participation
the symptoms of GERD : heartburn or acid reflux
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
Related trials for Gastro Esophageal Reflux
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
Enrolling by invitation
Endoscopic Treatment of Gastroesophageal Reflux Disease
Gastro Esophageal Reflux Disease
Enrolling by invitationObservational study
Assessment of Esophageal Epithelium Integrity With Use of a Novel Mucosal Impedance Device
Gastro Esophageal Reflux
RecruitingObservational study
Efficacy and Safety of Esomeprazole 40 mg IV in Post-Surgical Patients Admitted to the ICU
Stress Ulcers, Reflux Episodes
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.
Hwoon-Yong Jung, M.D, PhD principal investigator
Asan Medical Cental of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EsoDuo® Tablet in people with Gastro Esophageal Reflux, run by Chong Kun Dang Pharmaceutical 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 7 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: status not confirmed, as of the sponsor's last update on 28 May 2024. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hwoon-Yong Jung, M.D, PhD (82+2-3010-3197, hwoonymd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time taken to control the symptoms of GERD (time frame: 2 weeks after the clinical trial participation). 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 28 May 2024.