Study design
treatment-emergent adverse, HGP1705, GERD-related
EROSIVE ESOPHAGITIS, HEART
This study was designed as a multicenter, double-blind, randomized controlled, non-inferiority trial involving patients with erosive esophagitis (EE). Patients with EE were randomly assigned to receive either HIP1601 40 mg or HGP1705 40 mg for 4 or 8 weeks. Complete EE healing rates, GERD-related symptoms, and treatment-emergent adverse events (TEAE) were investigated and compared between both drugs. This study was conducted at 20 hospitals in Republic of Korea between October 2018 and November 2019. The study protocol was approved by the ethics committees of all participating hospitals, and written informed consent was obtained from each patient before enrollment (Asan Medical Center Institutional Review Board [A2018-1391], CMC Institutional Review Board [KC18MDDT0645], GangNeung Asan Hsopital Institutional Review Board [GNAH 2018-09-012], Kangbuk Samsung Hospital Institutional Review Board [KBSMC 2018-08-040], Korea University Guro Hospital Institutional Review Board [2018GR0399], Kosin University Gospel Hospital Institutional Review Board [KUGH 2018-08-029], Pusan National University Hospital Institutional Review Board [D-1809-003-081], Seoul National University Hospital Institutional Review Board [H-1808-183-970], Severance Hospital Institutional Review Board [4-2018-1229], Soonchunhyang University Hospital Bucheon Institutional Review Board [SCHBC 2018-09-005], Ajou University Hospital Institutional Review Board [AJIRB-MED-CT3-18-327], Yeungnam University Hospital Institutional Review Board [2018-08-045], Wonkwang University Hospital Institutional Review Board [WKUH 2018-09-008], Ewha womans university medical center Institutional Review Board [EUMC 2018-09-004], Inje University Seoul Paik Hospital Institutional Review Board [PAIK 2018-09-003], Chonnam National University Hospital Institutional Review Board [CNUH-2018-237], Chungnam National University Hospital Institutional Review Board [CNUH-2018-063], Kyungpook National University Chilgok Hospital Institutional Review Board [KNUCH 2018-08-035], Hallym University Sacred Heart Hospital Institutional Review Board [HALLYM 2018-08-033] & Seoul National University Bundang Hospital Institutional Review Board [B-1904-532-405]). This trial has been registered in Clinical Trials. (NCT04080726, registration date: 25/10/2018, 