CompletedNot Applicable

Study to Evaluate the Efficacy and Safety of FEXUCLUE Tablet

South Korea9,846 participantsStarted 2023-05-22

Plain-language summary

This observational study is a large-scale, prospective, and multi-institutional observational study. Patients from 19 to 75 years of age, will take a self-assessment (PRO) during the study period before and after administration of Pexuclue tablet.

Who can participate

Age range19 Years – 75 Years

SexALL

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Inclusion criteria

✓. Adult aged 19 years to 75 years (on registration date)
✓. Patient scheduled to administer Fexuclue tablet based on the medical judgment of investigator.
✓. Patient who has not taken a treatment for gastroesophageal reflux disease within two weeks from baseline visit.
✓. Patient who agreed to participate in this observation study and signed Informed Consent Form

Exclusion criteria

✕. A person who falls under the prohibition of administration according to the permission for Fexuclue Tablet
✕. A person who has taken a treatment for gastroesophageal reflux disease within two weeks from baseline visit.
✕. 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

What they're measuring

Change in the average score of the degree of individual symptoms of subjective symptoms (RDQ)

Timeframe: at least 4 weeks (up to 8 weeks)

Change in the average score of the frequency of individual symptoms of subjective symptoms (RDQ)

Timeframe: at least 4 weeks (up to 8 weeks)

Trial details

NCT IDNCT05886933

SponsorDaewoong Pharmaceutical Co. LTD.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-04-30

View on ClinicalTrials.gov More Gastroesophageal Reflux Disease trials