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

Su Hyun Park, Kang Nyeong Lee, Oh Young Lee, Myung Gyu Choi, Jie-Hyun Kim, In-Kyung Sung, Jae Young Jang, Kyung Sik Park, Hoon Jai Chun, Eun Young Kim, Jun Kyu Lee, Jin Seok Jang, Gwang Ha Kim, Su Jin Hong, Yong Chan Lee, Suck-Chei Choi, Hyun Soo Kim, Tae Oh Kim, Gwang Ho Baik, Yong Cheol Jeon, Su Hyun Park, Kang Nyeong Lee, Oh Young Lee, Myung Gyu Choi, Jie-Hyun Kim, In-Kyung Sung, Jae Young Jang, Kyung Sik Park, Hoon Jai Chun, Eun Young Kim, Jun Kyu Lee, Jin Seok Jang, Gwang Ha Kim, Su Jin Hong, Yong Chan Lee, Suck-Chei Choi, Hyun Soo Kim, Tae Oh Kim, Gwang Ho Baik, Yong Cheol Jeon

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).

Keywords: Esomeprazole; Gastroesophageal reflux; Phase IV clinical trial; Sodium bicarbonate.

Conflict of interest statement

CONFLICTS OF INTEREST

The study was sponsored and conducted by Chong Kun Dang Pharmaceutical Corp.

J.H.K., G.H.K., and Y.C.L. are editorial board members of the journal but were not involved in the peer reviewer selection, evaluation, or decision process of this article. No other potential conflicts of interest relevant to this article were reported.

Figures

Fig. 1
Fig. 1
Enrollment, randomization, and follow-up of patients. FAS, full analysis set; PPS, per-protocol set.

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Source: PubMed

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