A Multicenter, Randomized, Double-blind, Active-controlled Phase 4 Study to Evaluate the Efficacy and Safety of EsoDuo Tab. 20/800mg in Patients With Non-erosive Reflux Disease(NERD)

To Evaluate the Efficacy and Safety of EsoDuo Tab. 20/800mg

开始日期2019-01-29

申办/合作机构

Chong Kun Dang Pharmaceutical Corp.

100 项与埃索美拉唑/碳酸氢钠相关的临床结果

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100 项与埃索美拉唑/碳酸氢钠相关的转化医学

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100 项与埃索美拉唑/碳酸氢钠相关的专利（医药）

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项与埃索美拉唑/碳酸氢钠相关的文献（医药）

2023-03-15·Gut and Liver

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

Article

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

Background/AimsEfficacy 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.MethodsThis 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.ResultsA 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.ConclusionsEsoduo^Ⓡ is as effective and safe as Nexium^Ⓡ for managing typical symptoms in patients with NERD (ClinicalTrial.gov identifier: NCT03928470).

2008-09-01·Journal of Pharmaceutical and Biomedical Analysis3区 · 医学

Compatibility studies between mannitol and omeprazole sodium isomers

3区 · 医学

Article

作者: B.D. Glass ; S. Agatonovic-Kustrin ; N. Markovic ; M. Ginic-Markovic ; M. Mangan

Omeprazole, commonly used in the treatment of various gastrointestinal disorders degrades rapidly in acidic pHs and results in inter-individual variability due to different rates of metabolism amongst patients. Since S-omeprazole shows more predictable bioavailability and excipients have been known to interact with active pharmaceutical ingredients to produce altered bioavailability, it was decided to investigate the compatibility of omeprazole sodium isomers with mannitol, the major excipient in omeprazole formulations using differential scanning calorimetry (DSC) for bulk drug, attenuated total reflectance (ATR) infrared (IR) spectroscopy in a powder mixture and localized thermal analysis (LTA) from a drug disk. DSC results clearly indicate an interaction between mannitol and R-omeprazole sodium due to decreased melting temperatures and broadening peaks. The DSC of S-omeprazole sodium does not show melting temperature although the drug was crystalline. Because of the accelerated temperature conditions during DSC experiments applied in this work, ATR-IR was undertaken to determine whether these results occurred at room temperature for the solid dosage form. The ATR-IR results show a difference between R- and S-omeprazole sodium with mannitol by the appearance of both the amino (N-H) and imino (N-H) stretching frequencies for R-omeprazole and only the N-H for the S-omeprazole sodium. It may thus be concluded that different ratios for the tautomeric forms for S- and R-omeprazole sodium result in changes in the degree of crystallinity and are responsible for the interaction with mannitol, common excipient in formulation. These interactions may be directly related to the difference in terms of bioavailability.

100 项与埃索美拉唑/碳酸氢钠相关的药物交易

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