Samsung Medical Center
Seoul, South Korea
NCT Number: NCT05660122
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.
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Notify Me19 year–75 year
All sexes
Observational
Seoul, South Korea
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).
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Fexuclue Tablet 40mg
Other names: Fexuclue Tablet
Time frame: at 4 weeks (up to 8 weeks)
Average score change in RDQ at 4 weeks (up to 8 weeks) from baseline
Time frame: at 4 weeks (up to 8 weeks)
Average individual score change in RDQ at 4 weeks (up to 8 weeks) from baseline
Time frame: at 4 weeks (up to 8 weeks)
RDQ validity rate at 4 weeks (up to 8 weeks) from baseline
Time frame: at 4 weeks (up to 8 weeks)
Overall improvement evaluated by the subjects at 4 weeks (up to 8 weeks) from baseline
Time frame: at 4 weeks (up to 8 weeks)
Overall improvement evaluated by the researchers at 4 weeks (up to 8 weeks) from baseline
Daewoong Pharmaceutical Co. LTD.
Industry
A Multi-Center, Prospective, Observational Study to Evaluate the Improvement Effect on Subjective Symptom of FEXUCLUE Tab. in Patients With Erosive Gastroesophageal Reflux Disease
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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