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

Daewoong Pharmaceutical

Status: Active, not recruiting

Conditions: Gastroesophageal Reflux Disease

Treatments: Drug: Fexuprazan Hydrochloride

Study type: Observational

Funder types: Industry

Identifiers

NCT05660122

DWFE_P405

Details and patient eligibility

About

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.

Full 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).

Enrollment: 2,874 estimated patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

2,874 participants in 1 patient group

Treatment group

Description:

patients with gastroesophageal reflux disease

Treatment:

Drug: Fexuprazan Hydrochloride