Clinical trial NCT05614752: Study to Evaluate the Improvement Effect on Subjective Symptom of FEXUCLUE Tab
Official title: A Multi-Center, Prospective, Observational Study to Evaluate the Improvement Effect on Subjective Symptom of FEXUCLUE Tab. in Patients With Erosive Gastroesophageal Reflux Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux Disease
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2022-11-14
Enrollment: 10067
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population was calculated by the average of changes and standard deviation at two weeks and by referring to Michael Shaw et al. (2008)'s RDQ score (reverse flow, heartburn, indigestion)

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).

Eligibility criteria: 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 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 participates in another clinical trial and is administering (applying) clinical trial drugs or clinical trial medical devices;
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

Primary outcomes:
measure: Average score change in RDQ
timeFrame: At least 2 weeks (up to 8 weeks)
Secondary outcomes:
measure: changes in average score of the individual symptoms (reflux, heartburn, indigestion)
timeFrame: At least 2 weeks (up to 8 weeks)
measure: RDQ validity rate
timeFrame: At least 2 weeks (up to 8 weeks)
measure: Overall improvement evaluated by the subjects
timeFrame: At least 2 weeks (up to 8 weeks)
measure: Overall improvement evaluated by the researchers
timeFrame: At least 2 weeks (up to 8 weeks)
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk National University Hospital
Study officials:
affiliation: Jeonbuk National University Hospital
name: Seungyoung Seo
role: PRINCIPAL_INVESTIGATOR
References: