drugset

drugset / Trial / NCT04080726

Efficacy and Safety of HIP1601 Capsule

NCT04080726 ↗

Phase 3 Completed 213 enrolled Hanmi Pharmaceutical Company Limited

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to investigate the safety and clinical efficacy of HIP1601 in patients with erosive gastroesphageal reflux disease.

Timeline

Start: 2018-10-25
Primary completion: 2019-12-03
Completion: 2019-12-03

Publications

Lim H, Park JK, Chung H, Lee SH, Park JM, Park JH, Kim GH, Shin SK, Hong SJ, Lee KJ, Park MI, Jung HK, Kim HS, Sung JK, Jeon SW, Choi SC, Moon JS, Kim N, Park JJ, Hong SH, Kim NY, Jung HY. Efficacy and safety of HIP1601 (dual delayed-release esomeprazole) 40 mg in erosive esophagitis compared to HGP1705 (delayed-release esomeprazole) 40 mg: a multicenter, randomized, double-blind, non-inferiority study. BMC Gastroenterol. 2023 Dec 18;23(1):447. doi: 10.1186/s12876-023-03087-6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Esomeprazole	Small molecule	40 mg	Oral

Indications