## Protocol Section
### Identification Module
**NCT ID:** NCT06430047

**Brief Title:** Efficacy and Safety of EsoDuo®

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

#### Organization Study ID Info
**ID:** B73_02GERD2107
#### Organization
**Class:** INDUSTRY
**Full Name:** Chong Kun Dang Pharmaceutical
### Status Module
#### Completion Date
**Date:** 2025-05

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-11-25

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Chong Kun Dang Pharmaceutical

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 \[RACER Study\]

### Conditions Module

**Conditions:**

- Gastro Esophageal Reflux

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 180

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: EsoDuo® Tablet

**Label:** Experimental Group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Experimental Group

**Description:** QD, PO

**Name:** EsoDuo® Tablet

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** the symptoms of GERD : heartburn or acid reflux

**Measure:** The time taken to control the symptoms of GERD

**Time Frame:** 2 weeks after the clinical trial participation

### Eligibility Module

**Eligibility 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.

**Minimum Age:** 19 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** hwoonymd@gmail.com

**Name:** Hwoon-Yong Jung, M.D, PhD

**Phone:** 82+2-3010-3197

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Seoul

**Contacts:**

***Contact 1:***

- **Name:** Hwoon-Yong Jung, PhD

- **Role:** CONTACT

***Contact 2:***

- **Email:** hwoonymd@gmail.com

- **Phone:** 82+2-3010-3197

- **Role:** CONTACT

**Country:** Korea, Republic of

**Facility:** Asan Medical Center

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Asan Medical Cental of Korea

**Name:** Hwoon-Yong Jung, M.D, PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000015154

- Term: Esophageal Motility Disorders

- ID: D000003680

- Term: Deglutition Disorders

- ID: D000004935

- Term: Esophageal Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000004066

- Term: Digestive System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC09

- Name: Ear, Nose, and Throat Diseases

### Condition Browse Module - Browse Leaves

- ID: M8880

- Name: Gastroesophageal Reflux

- Relevance: HIGH

- As Found: Gastro Esophageal Reflux

- ID: M17874

- Name: Esophageal Motility Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M17875

- Name: Esophageal Spasm, Diffuse

- Relevance: LOW

- As Found: Unknown

- ID: M6882

- Name: Deglutition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M8085

- Name: Esophageal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005764

- Term: Gastroesophageal Reflux

### Misc Info Module

- Version Holder: 2024-05-31
