Gastro Esophageal Reflux
Conditions
Brief summary
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 \[RACER Study\]
Interventions
DRUGEsoDuo® Tablet
QD, PO
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The time taken to control the symptoms of GERD | 2 weeks after the clinical trial participation | the symptoms of GERD : heartburn or acid reflux |
Countries
South Korea
Contacts
Primary ContactHwoon-Yong Jung, M.D, PhD
Outcome results
None listed