Study to Evaluate the Efficacy and Safety of FEXUCLUE Tablet

Completed

• Conditions: Gastroesophageal Reflux Disease

• Registration Number: NCT05886933
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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.

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).

Study Timeline

• Study Start: 2023-05-22
• Study First Submitted: 2023-05-24
• Study First Submitted QC: 2023-05-24
• Study First Posted: 2023-06-02
• Primary Completion: 2024-04-30
• Study Completion: 2024-12-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9846

Inclusion Criteria

1. Adult aged 19 years to 75 years (on registration date)
2. Patient scheduled to administer Fexuclue tablet based on the medical judgment of investigator.
3. Patient who has not taken a treatment for gastroesophageal reflux disease within two weeks from baseline visit.
4. Patient who agreed to participate in this observation study and signed Informed Consent Form

Exclusion Criteria

1. A person who falls under the prohibition of administration according to the permission for Fexuclue Tablet

   • Patients with hypersensitivity to the components of Fexuclue tablet or Fexuclue tablet and a history thereof
   • Patients undergoing Atazanavir, Nelfinavir or Lilpivirin-containing preparations
   • Pregnant and lactating women
   • Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabortion

2. A person who has taken a treatment for gastroesophageal reflux disease within two weeks from baseline visit.

3. In addition to the above, a person who has determined that the researcher (the doctor in charge) is not suitable for participation in this observation study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the average score of the degree of individual symptoms of subjective symptoms (RDQ)	at least 4 weeks (up to 8 weeks)	Average score change in Reflux Disease Questionnaire (0 \~5) from baseline
Change in the average score of the frequency of individual symptoms of subjective symptoms (RDQ)	at least 4 weeks (up to 8 weeks)	Average score change in Reflux Disease Questionnaire (0 \~5) from baseline

Secondary Outcome Measures

Name	Time	Method
RDQ validity rate	at least 4 weeks (up to 8 weeks)	RDQ validity rate at 4 weeks(up to 8 weeks) from baseline
RDQ loss rate	at least 4 weeks (up to 8 weeks)	RDQ loss rate at 4 weeks(up to 8 weeks) from baseline
Quality of Life (GERD-HRQL) Total score change	at least 4 weeks (up to 8 weeks)	Quality of Life (GERD-HRQL) Total score change at 4 weeks(up to 8 weeks) from baseline
Changes in average score of the degree by symptoms (reflux, heartburn, indigestion)	at least 4 weeks (up to 8 weeks)	Average score change in Reflux Disease Questionnaire (0 \~5) from baseline
Overall improvement evaluated by the subjects	at least 4 weeks (up to 8 weeks)	Overall improvement result (scale 1\~5, Fully recovered/Much improvement/Moderate improvement/Unchanged/Aggravated) evaluated by the subjects at 4 weeks(up to 8 weeks) from baseline
Overall improvement evaluated by the researchers	at least 4 weeks (up to 8 weeks)	Overall improvement result (scale 1\~5, Fully recovered/Much improvement/Moderate improvement/Unchanged/Aggravated) evaluated by the researchers at 4 weeks(up to 8 weeks) from baseline
Changes in average score of the frequency by symptoms (reflux, heartburn, indigestion)	at least 4 weeks (up to 8 weeks)	Average score change in Reflux Disease Questionnaire (0 \~5) from baseline

Trial Locations

Locations (1)

Co&Ping Otolaryngology Clinic; 🇰🇷 Busan, Korea, Republic of