Gastroesophageal Reflux Disease
Conditions
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).
Interventions
Fexuclue Tablet 40mg
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| RDQ validity rate | at 4 weeks (up to 8 weeks) | RDQ validity rate 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 |
| 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 |
Countries
South Korea
Outcome results
None listed