Efficacy and Safety of EsoDuo®

Gastro Esophageal Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06430047
• Other study ID #: B73_02GERD2107
• Status: Recruiting
• Phase: Phase 4
• Start date: November 25, 2022
• Est. completion date: May 2025

Study information

• Verified date: May 2024
• Source: Chong Kun Dang Pharmaceutical
• Contact: Hwoon-Yong Jung, M.D, PhD
• Phone: 82+2-3010-3197
• Email: hwoonymd[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: May 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastro Esophageal Reflux
• Gastroesophageal Reflux

Intervention

Drug:
• EsoDuo® Tablet
QD, PO

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time taken to control the symptoms of GERD	the symptoms of GERD : heartburn or acid reflux	2 weeks after the clinical trial participation