NCT05660122

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,852 (actual)
• Sponsor: Daewoong Pharmaceutical Co. LTD. · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: —

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

Interventions

Type	Name	Description
DRUG	Fexuprazan Hydrochloride	Fexuclue Tablet 40mg

Timeline

• Start date: 2022-11-11
• Primary completion: 2024-12-26
• Completion: 2025-08-11
• First posted: 2022-12-21
• Last updated: 2025-09-04

Locations

1 site across 1 country: South Korea