NCT06430047

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2022

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 25, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 28, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

May 28, 2024

Status Verified

May 1, 2024

Enrollment Period

2.1 years

First QC Date

May 21, 2024

Last Update Submit

May 21, 2024

Conditions

Gastro Esophageal Reflux

Outcome Measures

Primary Outcomes (1)

  • The time taken to control the symptoms of GERD

    the symptoms of GERD : heartburn or acid reflux

    2 weeks after the clinical trial participation

Study Arms (1)

Experimental Group

EXPERIMENTAL
Drug: EsoDuo® Tablet

Interventions

EsoDuo® TabletDRUG

QD, PO

Experimental Group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Hwoon-Yong Jung, M.D, PhD

    Asan Medical Cental of Korea

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hwoon-Yong Jung, M.D, PhD

CONTACT

82+2-3010-3197hwoonymd@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2024

First Posted

May 28, 2024

Study Start

November 25, 2022

Primary Completion

January 1, 2025

Study Completion

May 1, 2025

Last Updated

May 28, 2024

Record last verified: 2024-05

Locations

KR(1)