Clinical trial NCT05660122: A Study to Evaluate the Improvement Effect on Subjective Symptom of FEXUCLUE Tab
Official title: A Multi-Center, Prospective, Observational Study to Evaluate the Improvement Effect on Subjective Symptom of FEXUCLUE Tab. in Patients With Erosive Gastroesophageal Reflux Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Gastroesophageal Reflux Disease
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2022-12-21
Enrollment: 2874
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This observation research plan assumes the following.

1. level of signification, α=0.05
2. Distance from Mean to Limits = 0.067
3. Standard deviation of the amount of change at the time of two weeks compared to the baseline of the RDQ score = 1.66

As a result of calculating using PASS2020 based on the above assumptions, the number of study subjects required to conduct this study was 2,359. In consideration of the dropout rate of about 20% in the calculated results, we intend to recruit 3,000 study subjects.

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).

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

Primary outcomes:
measure: Average score change in RDQ
timeFrame: at 4 weeks (up to 8 weeks)
Secondary outcomes:
measure: Average individual score change in RDQ
timeFrame: at 4 weeks (up to 8 weeks)
measure: RDQ validity rate
timeFrame: at 4 weeks (up to 8 weeks)
measure: Overall improvement evaluated by the subjects
timeFrame: at 4 weeks (up to 8 weeks)
measure: Overall improvement evaluated by the researchers
timeFrame: at 4 weeks (up to 8 weeks)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: