Observationa Study is a Prospective and Multi-institution... | NCT06952855

Studies
Observationa Study is a Prospective and Multi-institutional Observational Study.

NCT06952855

Sponsor

Jeil Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

May 13, 2025Actual

Enrollment

5,536Actual

Phase

Not provided

Conditions

Erosive Reflux Disease
Heartburn
Acid Regurgitation

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2024Actual

Primary Completion Date

Apr 23, 2025Actual

Completion Date

Apr 23, 2025Actual

First Submitted Date

Mar 11, 2025

First Submission Date that Met QC Criteria

Apr 28, 2025

First Posted Date

May 1, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2025

Last Update Posted Date

May 13, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This observational study is a prospective, multi-institutional non intervention study to examine the prescription patterns, corresponding treatment effects and safety in routine clinical practice for patients prescribed for the treatment of gastroesophageal reflux disease.

Detailed Description

The present observational study is designed to check effect and safety for patients who have been prescribed JAQBO for the treatment of erosive gastroesophageal reflux disease.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,536Actual

Label	Type	Description	Intervention Names
1 cohort		No interventions

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in GERD (heartburn, acid regurgitation) score in RDQ	Scale(none / 1day / 2day/ 3-4 day / 5-6 day/ every day)	4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

An adult over 19 years of age
A person who voluntarily provides written informed consent

Exclusion Criteria:

A pregnant woman or a nursing woman
A person who is deemed unsuitable for the subject of the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

GERD patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Goodbreath Medical Center		Seoul	Gyeonggi-do	15865	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006356	Heartburn
D005764	Gastroesophageal Reflux

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D015154	Esophageal Motility Disorders

Browse Leaves

Not provided

Browse Branches

Not provided