Efficacy and Safety of EsoDuo®

Chong Kun Dang

Status and phase: Enrolling; Phase 4

Conditions: Gastro Esophageal Reflux

Treatments: Drug: EsoDuo® Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT06430047

B73_02GERD2107

Details and patient eligibility

About

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

Full description

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

Enrollment: 180 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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180 participants in 1 patient group

Experimental Group

Experimental group

Treatment:

Drug: EsoDuo® Tablet