Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-26 @ 1:39 AM
Study NCT ID:
NCT05886933
Status:
COMPLETED
Last Update Posted:
2025-01-24
First Post:
2023-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Efficacy and Safety of FEXUCLUE Tablet
Sponsor:
Daewoong Pharmaceutical Co. LTD.
Organization:
Study Overview
Official Title:
A Prospective, Non-Intervention, Multi-Center Observational Study to Evaluate the Efficacy and Safety of FEXUCLUE Tablet in Patients With Erosive Gastroesophageal Reflux Disease
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This observational study is a large-scale, prospective, and multi-institutional observational study.
Patients from 19 to 75 years of age, will take a self-assessment (PRO) during the study period before and after administration of Pexuclue tablet.
Patients from 19 to 75 years of age, will take a self-assessment (PRO) during the study period before and after administration of Pexuclue tablet.
Detailed Description:
Data will be collected based on patient's medical records from daily visit. Enrolled subjects will take a Patient Reported Outcome (PRO) survey including Quality of life evaluation (GERD-HRQL) and self-awareness symptom (RDQ).
The survey will be done twice (before and after the administration of Fexuclue tablet) electronically through an application (e-PRO).
The survey will be done twice (before and after the administration of Fexuclue tablet) electronically through an application (e-PRO).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: