奥美拉唑/碳酸氢钠/氢氧化镁(Magnesium Hydroxide/Omeprazole/Sodium Bicarbonate) - 药物靶点：Proton pump_在研适应症：十二指肠溃疡，胃溃疡，良性胃溃疡_专利_临床

概要

基本信息

药物类型

小分子化药

别名

奥美钠镁、Zegerid

靶点

Proton pump

作用机制

质子泵抑制剂

治疗领域

在研适应症

非在研适应症

原研机构

在研机构-

非在研机构

沈阳亿灵医药科技有限公司

Santarus, Inc.

河北武罗药业有限公司

+ [3]

最高研发阶段临床3期

首次获批日期

美国 (2009-12-04),

十二指肠溃疡糜烂性食管炎良性胃溃疡+ [3]

最高研发阶段(中国)临床3期

特殊审评-

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结构

分子式C17H19N3O3S

InChIKeySUBDBMMJDZJVOS-UHFFFAOYSA-N

CAS号73590-58-6

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关联

12

项与奥美拉唑/碳酸氢钠/氢氧化镁相关的临床试验

CTR20182169 / Completed

奥美钠镁咀嚼片健康人体药代动力学对比试验

本试验旨在研究奥美钠镁咀嚼片在中国健康志愿者中的单次及多次给药药代动力学特征，并与阿斯利康制药有限公司生产的奥美拉唑镁肠溶片(商品名：洛赛克)进行对比药代动力学研究，评价两种制剂间的药代动力学特征。

开始日期2018-08-13

申办/合作机构

山东百诺医药股份有限公司

CTR20170849 / Recruiting临床2期

奥美钠镁咀嚼片治疗胃溃疡有效性和安全性的随机、双盲双模拟、阳性药物平行对照、多中心临床试验

与奥美拉唑镁肠溶片（洛赛克®）进行对比，评价奥美钠镁咀嚼片治疗胃溃疡的有效性和安全性

开始日期2017-10-06

申办/合作机构

山东百诺医药股份有限公司

CTR20170855 / Active, not recruiting临床2期

奥美钠镁咀嚼片治疗十二指肠溃疡有效性和安全性的随机、双盲双模拟、阳性药物平行对照、多中心临床试验

与奥美拉唑镁肠溶片（洛赛克®）进行对比，评价奥美钠镁咀嚼片治疗十二指肠溃疡的有效性和安全性

开始日期2017-09-20

申办/合作机构

山东百诺医药股份有限公司

100 项与奥美拉唑/碳酸氢钠/氢氧化镁相关的临床结果

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100 项与奥美拉唑/碳酸氢钠/氢氧化镁相关的转化医学

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100 项与奥美拉唑/碳酸氢钠/氢氧化镁相关的专利（医药）

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6

项与奥美拉唑/碳酸氢钠/氢氧化镁相关的文献（医药）

2015-01-01·Digestive Diseases and Sciences3区 · 医学

Once-Daily Omeprazole/Sodium Bicarbonate Heals Severe Refractory Reflux Esophagitis with Morning or Nighttime Dosing

3区 · 医学

Article

作者: Michael D. Crowell ; Diana M. Orbelo ; Jeffrey A. Alexander ; Matthew Lohse ; David A. Katzka ; Vikneswaran Namasivayam ; Margaret S. Houston ; Mary Fredericksen ; Tushar S. Dabade ; Amindra S. Arora ; Ramona S. DeJesus ; Sami R. Achem ; Angela E. O’Neil ; Joseph A. Murray ; Steven C. Adamson ; Nancy N. Diehl ; Debra M. Geno ; Kee Wook Jung ; Dawn L. Francis ; Felicity T. Enders ; Yvonne Romero ; Andrew J. Majka

BACKGROUNDMorning dose or twice-daily proton pump inhibitor (PPI) use is often prescribed to heal severe reflux esophagitis.AIMCompare the effect of single dose morning (control arm) versus nighttime (experimental arm) omeprazole/sodium bicarbonate (Zegerid(®)) (IR-OME) on esophagitis and gastroesophageal reflux symptoms.METHODSAdult outpatients with Los Angeles grade C or D esophagitis were allocated to open-label 40 mg IR-OME once a day for 8 weeks in a prospective, randomized, parallel design, single center study. Esophagogastroduodenoscopy (EGD) and validated self-report symptom questionnaires were completed at baseline and follow-up. Intention-to-treat and per-protocol analyses were performed.RESULTSNinety-two of 128 (72 %) eligible subjects participated [64 (70 %) male, mean age 58 (range 19-86), median BMI 29 (range 21-51), 58 C:34 D]. Overall, 81 (88 %) subjects healed [n = 70 (76 %)] or improved [n = 11 (12 %)] erosions. There was no significant difference (morning vs. night) in mucosal healing [81 vs. 71 %, (p = 0.44)] or symptom resolution [heartburn (77 vs. 65 %, p = 0.12), acid regurgitation (82 vs. 73 %, p = 0.28)]. Prevalence of newly identified Barrett's esophagus was 14 % with half diagnosed only after treatment.CONCLUSIONSOnce-daily IR-OME (taken morning or night) effectively heals severe reflux esophagitis and improves GERD symptoms. Results support the clinical practice recommendation to repeat EGD after 8 weeks PPI therapy in severe esophagitis patients to assure healing and exclude Barrett's esophagus.

2005-12-01·Alimentary Pharmacology & Therapeutics1区 · 医学

Review article: putting immediate‐release proton‐pump inhibitors into clinical practice – improving nocturnal acid control and avoiding the possible complications of excessive acid exposure

1区 · 医学

Review

作者: Katz, P O

SummaryNocturnal gastro‐oesphageal reflux is an under‐appreciated clinical challenge. This condition may cause symptoms such as nocturnal heartburn, or it may be asymptomatic. In addition, patients may experience sleep disturbances that can potentially lead to complications such as erosive oesophagitis and Barrett's oesophagus, and may be a risk factor for development of oesophageal adenocarcinoma. Delayed‐release proton‐pump inhibitors (PPIs) have traditionally been effective in treating both daytime and night‐time reflux symptoms, but are limited in control of nocturnal acidity by their pharmacodynamic characteristics.This narrative review addresses the prevalence, impact and pharmacologic approaches used to control nocturnal acidity. Methods to optimize nocturnal acid control include careful attention to dosing schedule, using higher doses of PPIs, adding an histamine H2‐receptor antagonist at bedtime to once or twice daily delayed‐release PPI, or using immediate‐relase omeprazole (Zegerid powder for oral suspension; Santarus, Inc., San Diego, CA, USA).This new formulation appears to provide sustained control of intragastric pH at steady state, and when dosed at bedtime, and may be effective in improving control of nocturnal pH and treating night‐time GERD.

2005-12-01·Alimentary Pharmacology & Therapeutics1区 · 医学

Review article: immediate‐release proton‐pump inhibitor therapy – potential advantages

1区 · 医学

Review

作者: Howden, C W

SummaryThe absorption of most oral proton‐pump inhibitors is delayed by the enteric coating required to protect the acid‐labile proton‐pump inhibitor from degradation in the stomach and, as a result, antisecretory effect is also delayed.This article provides an overview of the pharmacokinetics and pharmacodynamics of a new immediate‐release omeprazole [(IR‐OME) Zegerid power for oral suspension; Santarus Inc., San Diego, CA, USA] and its potential advantages over delayed‐release proton‐pump inhibitors.Immediate‐release omeprazole has a higher mean peak plasma omeprazole concentration (Cmax) and a significantly shorter mean time to reach Cmax (tmax) than delayed‐release omeprazole. Immediate‐release omeprazole 40 mg has a prolonged antisecretory effect with median intragastric pH above 4.0 for 18.6 h/day at steady‐state, after 7 days of once daily dosing. The sodium bicarbonate in immediate‐release omeprazole protects the uncoated omeprazole from degradation by gastric acid. The accelerated antisecretory action of immediate‐release omeprazole compared with delayed‐release omeprazole may be due to the activation of proton pumps by the rapid neutralization of intragastric acid by the sodium bicarbonate. The faster onset of action seen with immediate‐release omeprazole is not achieved by using an antacid with a delayed‐release proton‐pump inhibitor, because administering antacids with conventional delayed‐release proton‐pump inhibitors does not significantly enhance absorption of the proton‐pump inhibitor.In conclusion, immediate‐release omeprazole is associated with rapid absorption of omeprazole and rapid onset of antisecretory effect, without compromising the duration of acid suppression.

100 项与奥美拉唑/碳酸氢钠/氢氧化镁相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	奥美拉唑/碳酸氢钠/氢氧化镁	-	-

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
胃溃疡	临床2期	美国	Santarus, Inc.	2009-12-04
十二指肠溃疡	临床1期	美国	Santarus, Inc.	2009-12-04
胃溃疡	临床1期	美国	Santarus, Inc.	2009-12-04
胃食管反流	药物发现	美国	Santarus, Inc.	2009-12-04

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01493089 (Pubmed \| J Biol Chem)	临床3期	胃食管反流	239	Zegerid (20 mg)	遞積醖網網構繭鹹蓋網(齋願遞觸鏇鏇遞淵選繭) = 積憲憲憲壓淵繭壓繭選獵繭簾製齋鏇構鹽膚積 (繭觸範窪夢鏇構襯鬱鹽 ) 更多	-	2015-01-01
				Losec (20 mg)	遞積醖網網構繭鹹蓋網(齋願遞觸鏇鏇遞淵選繭) = 醖築鹹醖構壓鏇艱簾鏇獵繭簾製齋鏇構鹽膚積 (繭觸範窪夢鏇構襯鬱鹽 ) 更多
NCT01129778 (CTgov)	N/A	胃食管反流 \| 巴雷特食管	27	Bravo pH monitoring+Zegerid (proton pump inhibitor)	(範範糧鏇糧顧餘簾廠淵) = 淵遞廠淵廠鏇憲窪製網願鏇築願餘獵製鹽窪淵 (簾繭範夢窪獵齋獵艱鑰, 觸鹽蓋觸選觸積壓齋選 ~ 簾積壓鬱築窪顧鏇憲蓋) 更多	-	2017-06-06
NCT01493089 (CTgov)	临床3期	胃食管反流 \| 胃灼热	239	Zegerid (Zegerid)	築遞鹹餘艱夢構選壓艱(簾夢鑰蓋襯蓋艱鬱膚蓋) = 築壓窪顧醖鏇餘壓窪糧網鹹艱鬱膚選鬱膚壓簾 (膚獵膚淵鹽艱繭蓋製鹹, 範選顧鬱範選淵網蓋憲 ~ 鹽淵糧齋齋鏇獵選遞製) 更多	-	2013-08-13
				Losec (Losec)	築遞鹹餘艱夢構選壓艱(簾夢鑰蓋襯蓋艱鬱膚蓋) = 鹽衊構選蓋淵網餘齋憲網鹹艱鬱膚選鬱膚壓簾 (膚獵膚淵鹽艱繭蓋製鹹, 艱膚願糧繭鹹築鹹憲膚 ~ 廠襯蓋範衊鹹繭鹽遞積) 更多
NCT00808769 (CTgov)	临床4期	-	30	Prilosec OTC+Zegerid (Zegerid® Then Prilosec OTC®)	淵襯觸蓋鬱構獵築餘遞(艱鹹鬱淵鬱網膚鏇遞網) = 遞願壓簾廠繭網顧遞艱簾廠簾築夢壓範窪窪衊 (鏇簾醖遞膚衊網積廠築, 齋齋壓膚簾鹹製鹽齋壓 ~ 鬱襯壓範築顧製製簾糧) 更多	-	2011-04-27
				Prilosec OTC+Zegerid (Prilosec OTC® Then Zegerid®)	淵襯觸蓋鬱構獵築餘遞(艱鹹鬱淵鬱網膚鏇遞網) = 遞簾顧蓋膚蓋選選艱願簾廠簾築夢壓範窪窪衊 (鏇簾醖遞膚衊網積廠築, 壓積廠鹽膚齋壓願餘願 ~ 廠鑰憲鹹衊膚遞選遞獵) 更多