Efficacy and Safety of EsoDuo®
Phase 4
Recruiting
- Conditions
- Gastro Esophageal Reflux
- Interventions
- Drug: EsoDuo® Tablet
- Registration Number
- NCT06430047
- Lead Sponsor
- Chong Kun Dang Pharmaceutical
- 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 \[RACER Study\]
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 180
Inclusion Criteria
- 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)
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental Group EsoDuo® Tablet -
- Primary Outcome Measures
Name Time Method The time taken to control the symptoms of GERD 2 weeks after the clinical trial participation the symptoms of GERD : heartburn or acid reflux
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of