Clinical trial NCT05886933: Study to Evaluate the Efficacy and Safety of FEXUCLUE Tablet
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux Disease
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2023-06-02
Enrollment: 9846
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Referring to the minimum number of subjects required and the number of patients with gastroesophageal reflux disease in Korea, We expected to recruit about 16,000 people which is 0.2 %.

However, since this study is conducted under daily medical care, we expected 10% to be dropout rate.

Therefore the total study population is about 18,000

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 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

Primary outcomes:
measure: Change in the average score of the degree of individual symptoms of subjective symptoms (RDQ)
timeFrame: at least 4 weeks (up to 8 weeks)
measure: Change in the average score of the frequency of individual symptoms of subjective symptoms (RDQ)
timeFrame: at least 4 weeks (up to 8 weeks)
Secondary outcomes:
measure: Changes in average score of the degree by symptoms (reflux, heartburn, indigestion)
timeFrame: at least 4 weeks (up to 8 weeks)
measure: Changes in average score of the frequency by symptoms (reflux, heartburn, indigestion)
timeFrame: at least 4 weeks (up to 8 weeks)
measure: RDQ validity rate
timeFrame: at least 4 weeks (up to 8 weeks)
measure: RDQ loss rate
timeFrame: at least 4 weeks (up to 8 weeks)
measure: Overall improvement evaluated by the subjects
timeFrame: at least 4 weeks (up to 8 weeks)
measure: Overall improvement evaluated by the researchers
timeFrame: at least 4 weeks (up to 8 weeks)
measure: Quality of Life (GERD-HRQL) Total score change
timeFrame: at least 4 weeks (up to 8 weeks)
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Co&Ping Otolaryngology Clinic
Study officials:
affiliation: Co&Ping Otolaryngology Clinic
name: Homin Lee
role: PRINCIPAL_INVESTIGATOR
References: