Evaluating the effects of EsoDuo® on reflux symptoms
The Role of an EsoDuo® to Control Reflux Symptoms Related to the Acid; a Multicenter, Open-labeled, Phase 4 Study [RACER Study]
This study is testing if EsoDuo® can help people with reflux symptoms, like heartburn, feel better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Chong Kun Dang Pharmaceutical Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06430047 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of EsoDuo®, a medication aimed at controlling reflux symptoms related to acid. It is a multicenter, open-label, Phase 4 study that includes patients diagnosed with non-erosive or mild erosive reflux disease. Participants will receive EsoDuo® tablets and their symptoms will be monitored to assess the treatment's effectiveness. The study aims to provide insights into how well this medication can alleviate heartburn and other related symptoms.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 and older diagnosed with non-erosive or mild erosive reflux disease experiencing heartburn symptoms.
Not a fit: Patients with severe esophageal conditions, recent malignancy, or those who have undergone specific surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from gastroesophageal reflux disease.
How similar studies have performed: Other studies have shown promising results with similar interventions for reflux symptoms, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or Female aged ≥ 19 years 2. Patients diagnosed with non-erosive reflux disease or mild erosive reflux disease 3. Episode of heartburn the GERD symptom(either heartburn or gastric acid reflux) Exclusion Criteria: 1. Surgery history on stomach or esophagus 2. Barrett's esophagus (over 3cm), esophageal varices, esophageal stricture, esophageal achalasia, eosinophilic esophagitis, and primary motility disorders 3. Patients diagnosed with Grade C or Grade D according to the LA Classification system during upper gastrointestinal endoscopy 4. Patients with a history of malignancy within the past 5 years prior to the screening visit (Visit 1) 5. 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. 6. Clinically significant Abnormal Lab test 7. Pregnant woman, Breastfeeding woman.
Where this trial is running
Seoul
- Asan Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Hwoon-Yong Jung, M.D, PhD — Asan Medical Cental of Korea
- Study coordinator: Hwoon-Yong Jung, M.D, PhD
- Email: hwoonymd@gmail.com
- Phone: 82+2-3010-3197
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.