Efficacy and Safety of EsoDuo®

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-25

Study Completion Date

2025-05-31

Brief Summary

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

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Detailed Description

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

Conditions

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Gastro Esophageal Reflux

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental Group

Group Type EXPERIMENTAL

EsoDuo® Tablet

Intervention Type DRUG

QD, PO

Interventions

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EsoDuo® Tablet

QD, PO

Intervention Type DRUG

Eligibility Criteria

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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 Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No