Study to Evaluate the Efficacy and Safety of FEXUCLUE Tablet

NCT05886933 | Completed

• 1 other identifier: DWFE_P407
• Study Type: observational
• Target: 9,846
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux Disease

Outcome Measures

Primary Outcomes (2)

• Change in the average score of the degree of individual symptoms of subjective symptoms (RDQ)

  Average score change in Reflux Disease Questionnaire (0 \~5) from baseline

  at least 4 weeks (up to 8 weeks)

• Change in the average score of the frequency of individual symptoms of subjective symptoms (RDQ)

  Average score change in Reflux Disease Questionnaire (0 \~5) from baseline

  at least 4 weeks (up to 8 weeks)

Secondary Outcomes (7)

• Changes in average score of the degree by symptoms (reflux, heartburn, indigestion)

  at least 4 weeks (up to 8 weeks)

• Changes in average score of the frequency by symptoms (reflux, heartburn, indigestion)

  at least 4 weeks (up to 8 weeks)

• RDQ validity rate

  at least 4 weeks (up to 8 weeks)

• RDQ loss rate

  at least 4 weeks (up to 8 weeks)

• Overall improvement evaluated by the subjects

  at least 4 weeks (up to 8 weeks)

Interventions

Fexuprazan Hydrochloride DRUG

Patient treated with Fexuprazan Hydrochloride (Fexuclue Tablet)

Also known as: Fexuclue Tablet

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Co&Ping Otolaryngology Clinic

Busan, South Korea

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Homin Lee

  Co&Ping Otolaryngology Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 2, 2023
• Study Start: May 22, 2023
• Primary Completion: April 30, 2024
• Study Completion: December 31, 2024
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

KR (1)