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

A Multi-Center, Prospective, Observational Study to Evaluate the Improvement Effect on Subjective Symptom of FEXUCLUE Tab. in Patients With Erosive Gastroesophageal Reflux Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Gastroesophageal Reflux Disease
• Intervention / Treatment: Drug: Fexuprazan Hydrochloride

Detailed Description

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.

Subjects who met the inclusion/exclusion criteria will administer Fexuclue Tablet once a day for four weeks after registration, regardless of their meals. If esophagitis is not treated or symptoms continue after 4 weeks of administration, the subject will continue to administer Fexuclue Tablet for 4 more weeks (maximum administration period: 8 weeks).

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: HyeongSeon Noh; Phone Number: 8210-4266-0549; Email: hsno116@daewoong.co.kr

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Recruiting
    • Kosin University Gospel Hospital
    • Contact: KiEun Kwon; Phone Number: 051-990-6771; Email: kosinirb@kosinmed.or.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

1. Adult men and women aged 19 to 75 years of age at the time of registration.
2. 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.
3. A person who voluntarily agrees to participate in this observation study and signed the 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment group; patients with gastroesophageal reflux disease	Drug: Fexuprazan Hydrochloride; Fexuclue Tablet 40mg; Other Names: Fexuclue Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average score change	in Reflux Disease Questionnaire	at 4 weeks (up to 8 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average score change	individual score in Reflux Disease Questionnaire	at 4 weeks (up to 8 weeks)

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2022
• Primary Completion (Estimated): June 30, 2023
• Study Completion (Estimated): October 31, 2023

Study Registration Dates

• First Submitted: December 13, 2022
• First Submitted That Met QC Criteria: December 13, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Actual): May 26, 2023
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux; Gastrointestinal Agents; Fexuprazan
• Other Study ID Numbers: DWFE_P405

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No