A Randomized, Double-Blind, Active-Control, Noninferiority, Multicenter, Phase 4 Study to Evaluate the Efficacy and Safety of Esomeprazole/Sodium Bicarbonate 20/800 mg in Patients with Nonerosive Gastroesophageal Reflux Disease
- Authors
- Park Su Hyun; Lee Kang Nyeong; Lee Oh Young; Choi Myung Gyu; Kim Jie-Hyun; Sung In-Kyung; Jang Jae Young; Park Kyung Sik; Chun Hoon Jai; Kim Eun Young; Lee Jun Kyu; Jang Jin Seok; Kim Gwang Ha; Hong Su Jin; Lee Yong Chan; Choi Suck-Chei; Kim Hyun Soo; Kim Tae Oh; Baik Gwang Ho; Jeon Yong Cheol
- Issue Date
- Mar-2023
- Publisher
- 거트앤리버 발행위원회
- Keywords
- Gastroesophageal reflux; Phase IV clinical trial; Esomeprazole; Sodium bicarbonate
- Citation
- Gut and Liver, v.17, no.2, pp 226 - 233
- Pages
- 8
- Indexed
- SCIE
SCOPUS
KCI
- Journal Title
- Gut and Liver
- Volume
- 17
- Number
- 2
- Start Page
- 226
- End Page
- 233
- URI
- https://scholarworks.korea.ac.kr/kumedicine/handle/2021.sw.kumedicine/63953
- DOI
- 10.5009/gnl220023
- ISSN
- 1976-2283
2005-1212
- Abstract
- Background/Aims: Efficacy of proton pump inhibitors is limited in patients with nonerosive reflux disease (NERD). The aim of this study was to comparatively evaluate the efficacy and safety of esomeprazole with sodium bicarbonate and esomeprazole alone.
Methods: This was a multicenter, randomized, double-blind, active-controlled, noninferiority comparative study. A total of 379 patients with NERD were randomly allocated to receive either EsoduoⓇ (esomeprazole 20 mg with sodium bicarbonate 800 mg) or NexiumⓇ (esomeprazole 20 mg) once daily for 4 weeks from January 2019 to December 2019. The patients had a history of heartburn for at least 2 days in the week before randomization as well as in the last 3 months and no esophageal mucosal breaks on endoscopy. The primary endpoint was a complete cure of heartburn at week 4. The secondary and exploratory endpoints as well as the safety profiles were compared in the groups at weeks 2 and 4.
Results: A total of 355 patients completed the study (180 in the EsoduoⓇ group and 175 in the NexiumⓇ group). The proportions of patients without heartburn in the entire 4th week of treatment were not different between the two groups (33.33% in the EsoduoⓇ group and 35% in the NexiumⓇ group, p=0.737). There were no significant differences in most of the secondary and exploratory endpoints as well as the safety profiles.
Conclusions: EsoduoⓇ is as effective and safe as NexiumⓇ for managing typical symptoms in patients with NERD (ClinicalTrial.gov identifier: NCT03928470).
- Files in This Item
- There are no files associated with this item.
- Appears in
Collections - 2. Clinical Science > Department of Gastroenterology and Hepatology > 1. Journal Articles
Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.