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

NCT ID: NCT05660122

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2852 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-11
• Study Completion Date: 2025-08-11

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.

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).

Conditions

Gastroesophageal Reflux Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Treatment group

patients with gastroesophageal reflux disease

Fexuprazan Hydrochloride

Intervention Type: DRUG

Fexuclue Tablet 40mg

Interventions

Fexuprazan Hydrochloride

Fexuclue Tablet 40mg

Intervention Type: DRUG

Other Intervention Names

Fexuclue Tablet

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

DWFE_P405

Identifier Type: -

Identifier Source: org_study_id