Gut Liver.  2023 Mar;17(2):226-233. 10.5009/gnl220023.

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

Affiliations
  • 1Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea
  • 2Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea
  • 3Department of Internal Medicine, Gangnam Severance Hospital, Seoul, Korea
  • 4Department of Internal Medicine, Konkuk University College of Medicine, Seoul, Korea
  • 5Department of Internal Medicine, College of Medicine, Kyung Hee University, Seoul, Korea
  • 6Department of Internal Medicine, Keimyung University College of Medicine, Daegu, Korea
  • 7Department of Internal Medicine, Korea University Anam Hospital, Seoul, Korea
  • 8Department of Internal Medicine, Daegu Catholic University School of Medicine, Daegu, Korea
  • 9Department of Internal Medicine, Dongguk University Ilsan Hospital, Dongguk University College of Medicine, Goyang, Korea
  • 10Department of Internal Medicine, Dong-A University Hospital, Dong-A University College of Medicine, Busan, Korea
  • 11Department of Internal Medicine, Pusan National University School of Medicine, Busan, Korea
  • 12Department of Internal Medicine, Soonchunhyang University College of Medicine, Bucheon, Korea
  • 13Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
  • 14Department of Internal Medicine, Wonkwang University College of Medicine, Iksan, Korea
  • 15Department of Internal Medicine, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, Wonju, Korea
  • 16Department of Internal Medicine, Inje University Haeundae Paik Hospital, Busan, Korea
  • 17Department of Internal Medicine, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, Chuncheon, Korea
  • 18Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, Korea

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Ⓡ/sup> (esomeprazole 20 mg with sodium bicarbonate 800 mg) or NexiumⓇ/sup> (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Ⓡ/sup> group and 175 in the NexiumⓇ/sup> 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Ⓡ/sup> group and 35% in the NexiumⓇ/sup> 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Ⓡ/sup> is as effective and safe as NexiumⓇ/sup> for managing typical symptoms in patients with NERD (ClinicalTrial.gov identifier: NCT03928470).

Keyword

Gastroesophageal reflux; Phase IV clinical trial; Esomeprazole; Sodium bicarbonate
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