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

Active, not recruiting

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Drug: Fexuprazan Hydrochloride

• Registration Number: NCT05660122
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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).

Study Timeline

• Study Start: 2022-11-11
• Study First Submitted: 2022-12-13
• Study First Submitted QC: 2022-12-13
• Study First Posted: 2022-12-21
• Primary Completion: 2024-10-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-22
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2874

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment group	Fexuprazan Hydrochloride	patients with gastroesophageal reflux disease

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Overall improvement evaluated by the researchers	at 4 weeks (up to 8 weeks)	Overall improvement evaluated by the researchers at 4 weeks (up to 8 weeks) from baseline
RDQ validity rate	at 4 weeks (up to 8 weeks)	RDQ validity rate at 4 weeks (up to 8 weeks) from baseline
Average individual score change in RDQ	at 4 weeks (up to 8 weeks)	Average individual score change in RDQ at 4 weeks (up to 8 weeks) from baseline
Overall improvement evaluated by the subjects	at 4 weeks (up to 8 weeks)	Overall improvement evaluated by the subjects at 4 weeks (up to 8 weeks) from baseline

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of