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

NCT05660122 | Completed

• 1 other identifier: DWFE_P405
• Study Type: observational
• Target: 2,852
• Locations: 1 country
• Sites: 1

Brief Summary

This observation study is a large-scale, prospective, and multi-organ observation study to observe the improvement effect of the self-evaluation results (PRO) of erosive gastroesophageal reflux disease at least 4 to 8 weeks after administration of Fexuclue Tab.

Conditions

Gastroesophageal Reflux Disease

Outcome Measures

Primary Outcomes (1)

• Average score change in RDQ

  Average score change in RDQ at 4 weeks (up to 8 weeks) from baseline

  at 4 weeks (up to 8 weeks)

Secondary Outcomes (4)

• Average individual score change in RDQ

  at 4 weeks (up to 8 weeks)

• RDQ validity rate

  at 4 weeks (up to 8 weeks)

• Overall improvement evaluated by the subjects

  at 4 weeks (up to 8 weeks)

• Overall improvement evaluated by the researchers

  at 4 weeks (up to 8 weeks)

Study Arms (1)

Treatment group

patients with gastroesophageal reflux disease

Drug: Fexuprazan Hydrochloride

Interventions

Fexuprazan Hydrochloride DRUG

Fexuclue Tablet 40mg

Also known as: Fexuclue Tablet

Treatment group

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This observation research plan assumes the following. 1. level of signification, α=0.05 2. Distance from Mean to Limits = 0.067 3. Standard deviation of the amount of change at the time of two weeks compared to the baseline of the RDQ score = 1.66 As a result of calculating using PASS2020 based on the above assumptions, the number of study subjects required to conduct this study was 2,359. In consideration of the dropout rate of about 20% in the calculated results, we intend to recruit 3,000 study subjects.

You may qualify if:

• Adult men and women aged 19 to 75 years of age at the time of registration.
• A patient with erosive gastroesophageal reflux disease who is scheduled to administer Fexuclue Tab. for the first time based on the medical judgement of the researcher based on the medication authorization.
• A person who voluntarily agrees to participate in this observation study and signed the 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)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: December 21, 2022
• Study Start: November 11, 2022
• Primary Completion: December 26, 2024
• Study Completion: August 11, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

KR (1)