Study to Evaluate the Improvement Effect on Subjective Symptom of FEXUCLUE Tab

NCT05614752 | Completed

• 1 other identifier: DWFE_P406
• Study Type: observational
• Target: 10,067
• 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 (1)

• Average score change in RDQ

  Average score change in RDQ at least 2 weeks (up to 8 weeks) compared to baseline

  At least 2 weeks (up to 8 weeks)

Secondary Outcomes (4)

• changes in average score of the individual symptoms (reflux, heartburn, indigestion)

  At least 2 weeks (up to 8 weeks)

• RDQ validity rate

  At least 2 weeks (up to 8 weeks)

• Overall improvement evaluated by the subjects

  At least 2 weeks (up to 8 weeks)

• Overall improvement evaluated by the researchers

  At least 2 weeks (up to 8 weeks)

Study Arms (1)

Treatment group

treated with Fexuclue Tablet 40mg

Drug: Fexuprazan

Interventions

Fexuprazan DRUG

Fexuclue Tablet 40mg

Treatment group

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

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)

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

Jeonbuk National University Hospital

Jeonju, South Korea

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

fexuprazan

Condition Hierarchy (Ancestors)

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

Study Officials

• Seungyoung Seo

  Jeonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 14, 2022
• Study Start: July 6, 2022
• Primary Completion: December 31, 2023
• Study Completion: November 8, 2024
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

KR (1)