Evaluation of the Efficacy and Safety of DW1903 in Patients with Gastritis: A Randomized, Double-Blind, Noninferiority, Multicenter, Phase 3 study
- Authors
- Kim, Jie-Hyun; Jung, Hwoon-Yong; Yoo, In Kyung; Park, Seon-Young; Kim, Jae Gyu; Sung, Jae Kyu; Jang, Jin Seok; Cheon, Gab Jin; Kim, Kyoung Oh; Kim, Tae Oh; Lee, Soo Teik; Cho, Kwang Bum; Chun, Hoon Jai; Park, Jong-Jae; Park, Moo In; Jang, Jae-Young; Jeon, Seong Woo; Cho, Jin Woong; Kang, Dae Hwan; Kim, Gwang Ha; Kim, Jae J.; Kim, Sang Gyun; Kim, Nayoung; Lee, Yong Chan; Hong, Su Jin; Kim, Hyun-Soo; Lee, Sora; Lee, Sang Woo
- Issue Date
- Jun-2023
- Publisher
- 거트앤리버 발행위원회
- Keywords
- Gastritis; Phase III clinical trial; Proton pump inhibitors; Histamine H2 antagonists
- Citation
- Gut and Liver
- Indexed
- SCIE
SCOPUS
KCI
- Journal Title
- Gut and Liver
- URI
- https://scholarworks.korea.ac.kr/kumedicine/handle/2021.sw.kumedicine/63550
- DOI
- 10.5009/gnl220446
- ISSN
- 1976-2283
2005-1212
- Abstract
- Background/Aims
H2 receptor antagonists (H2RA) have been used to treat gastritis by inhibit-ing gastric acid. Proton pump inhibitors (PPIs) are more potent acid suppressants than H2RA. However, the efficacy and safety of low-dose PPI for treating gastritis remain unclear. The aim was to investigate the efficacy and safety of low-dose PPI for treating gastritis.
Methods
A double-blind, noninferiority, multicenter, phase 3 clinical trial randomly assigned 476 patients with endoscopic erosive gastritis to a group using esomeprazole 10 mg (DW1903) daily and a group using famotidine 20 mg (DW1903R1) daily for 2 weeks. The full-analysis set in-cluded 319 patients (DW1903, n=159; DW1903R1, n=160) and the per-protocol set included 298 patients (DW1903, n=147; DW1903R1, n=151). The primary endpoint (erosion improvement rate) and secondary endpoint (erosion and edema cure rates, improvement rates of hemorrhage, erythema, and symptoms) were assessed after the treatment. Adverse events were compared.
Results
According to the full-analysis set, the erosion improvement rates in the DW1903 and DW1903R1 groups were 59.8% and 58.8%, respectively. According to the per-protocol analysis, the erosion improvement rates in the DW1903 and DW1903R1 groups were 61.9% and 59.6%, respectively. Secondary endpoints were not significantly different between two groups except that the hemorrhagic improvement rate was higher in DW1903 with statistical tendency. The number of adverse events were not statistically different.
Conclusions
DW1903 of a low-dose PPI was not inferior to DW1903R1 of H2RA. Thus, low-dose PPI can be a novel option for treating gastritis (ClinicalTrials.gov Identifier: NCT05163756). (Gut Liver, Published online June 13, 2023)
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Collections - 2. Clinical Science > Department of Gastroenterology and Hepatology > 1. Journal Articles
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