CompletedNot Applicable

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

South Korea2,852 participantsStarted 2022-11-11

Plain-language 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.

Who can participate

Age range19 Years – 75 Years

SexALL

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Inclusion criteria

✓. Adult men and women aged 19 to 75 years of age at the time of registration.
✓. 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.
✓. A person who voluntarily agrees to participate in this observation study and signed the informed consent form.

Exclusion criteria

✕. A person who falls under the prohibition of administration according to the permission for Fexuclue Tablet
✕. A person who participates in another clinical trial and is administering (applying) clinical trial drugs or clinical trial medical devices;
✕. 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

Average score change in RDQ

Timeframe: at 4 weeks (up to 8 weeks)

Trial details

NCT IDNCT05660122

SponsorDaewoong Pharmaceutical Co. LTD.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-12-26

View on ClinicalTrials.gov More Gastroesophageal Reflux Disease trials