RecruitingPhase 4NCT06430047

Efficacy and Safety of EsoDuo®

The Role of an EsoDuo® to Control Reflux Symptoms Related to the Acid; a Multicenter, Open-labeled, Phase 4 Study [RACER Study]

Sponsor

Chong Kun Dang Pharmaceutical

Enrollment

180 participants

Start Date

Nov 25, 2022

Study Type

INTERVENTIONAL

Conditions

Clinical Trial to Evaluate the Effects of EsoDuo® in Controlling Reflux Symptoms Related to the Acid

Min Age: 19 Years

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)

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.