Delving into the Latest Updates on Magnesium Hydroxide/Omeprazole/Sodium Bicarbonate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

奥美钠镁, Zegerid

Target

Proton pump

Mechanism

Proton pump inhibitors

Therapeutic Areas

Digestive System Disorders

Active Indication

Duodenal UlcerStomach Ulcergastric ulcer benign

Inactive Indication

Erosive esophagitisEsophagitisGastroesophageal Reflux+ [2]

Originator Organization

Santarus, Inc.

Active Organization-

Inactive Organization

Shenyang Eliving Pharmaceutical Technology Co. Ltd.

Santarus, Inc.

Hebei Wuluo Pharmaceutical Co., Ltd

+ [3]

Drug Highest PhasePhase 3

First Approval Date

US (04 Dec 2009),

Duodenal UlcerErosive esophagitisgastric ulcer benign+ [2]

Regulation-

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Structure

Molecular FormulaC17H19N3O3S

InChIKeySUBDBMMJDZJVOS-UHFFFAOYSA-N

CAS Registry73590-58-6

View All Structures (3)

This study aims to study the pharmacokinetic characteristics of single and multiple doses of omeprazole magnesium chewable tablets in healthy Chinese volunteers, and to conduct a comparative pharmacokinetic study with omeprazole magnesium enteric-coated tablets (trade name: Losec) produced by AstraZeneca Pharmaceuticals Co., Ltd. to evaluate the pharmacokinetic characteristics of the two preparations.

Start Date13 Aug 2018

Sponsor / Collaborator

Shandong Bestcomm Pharmaceutical Co., Ltd.

CTR20170849 / RecruitingPhase 2

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

[Translation] A randomized, double-blind, double-dummy, positive drug parallel controlled, multicenter clinical trial on the efficacy and safety of Ogilvy sodium magnesium chewable tablets in the treatment of gastric ulcer

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

[Translation]

To compare with omeprazole magnesium enteric-coated tablets (Losec®) to evaluate the efficacy and safety of omeprazole magnesium chewable tablets in the treatment of gastric ulcer

Start Date06 Oct 2017

Sponsor / Collaborator

Shandong Bestcomm Pharmaceutical Co., Ltd.

CTR20170855 / Active, not recruitingPhase 2

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

[Translation] A randomized, double-blind, double-dummy, positive drug parallel controlled, multicenter clinical trial on the efficacy and safety of omeprazole sodium magnesium chewable tablets in the treatment of duodenal ulcer

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

[Translation]

To compare the efficacy and safety of omeprazole magnesium enteric-coated tablets (Losec®) with omeprazole magnesium enteric-coated tablets in the treatment of duodenal ulcers

Start Date20 Sep 2017

Sponsor / Collaborator

Shandong Bestcomm Pharmaceutical Co., Ltd.

100 Clinical Results associated with Magnesium Hydroxide/Omeprazole/Sodium Bicarbonate

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100 Translational Medicine associated with Magnesium Hydroxide/Omeprazole/Sodium Bicarbonate

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100 Patents (Medical) associated with Magnesium Hydroxide/Omeprazole/Sodium Bicarbonate

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6

Literatures (Medical) associated with Magnesium Hydroxide/Omeprazole/Sodium Bicarbonate

01 Jan 2015·Digestive Diseases and SciencesQ3 · MEDICINE

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

Q3 · MEDICINE

Article

Author: 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 ; Joseph A. Murray ; Sami R. Achem ; Angela E. O’Neil ; 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.

01 Dec 2005·Alimentary Pharmacology & TherapeuticsQ1 · MEDICINE

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

Q1 · MEDICINE

Review

Author: 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.

01 Dec 2005·Alimentary Pharmacology & TherapeuticsQ1 · MEDICINE

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

Q1 · MEDICINE

Review

Author: 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 Deals associated with Magnesium Hydroxide/Omeprazole/Sodium Bicarbonate

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External Link

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Stomach Ulcer	Preclinical	CN	Beijing Novel Pharm Co., Ltd.	12 Apr 2016
Esophagitis	Discovery	CN	Hebei Wuluo Pharmaceutical Co., Ltd	21 Jul 2017
Stomach Ulcer	Discovery	CN	Beijing Novel Pharm Co., Ltd.	12 Apr 2016
Duodenal Ulcer	Discovery	US	Santarus, Inc.	04 Dec 2009
Gastroesophageal Reflux	Discovery	US	Santarus, Inc.	04 Dec 2009

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01493089 (Pubmed \| J Biol Chem)	Phase 3	Gastroesophageal Reflux	239	Zegerid (20 mg)	luvefybums(gcsiljlrfp) = wvhzcwmqwi vfkebmascc (kmkkhuzihr ) View more	-	01 Jan 2015
				Losec (20 mg)	luvefybums(gcsiljlrfp) = ojufeariml vfkebmascc (kmkkhuzihr ) View more
NCT01493089 (CTgov)	Phase 3	Gastroesophageal Reflux \| Heartburn	239	Zegerid (Zegerid)	uduwnpqquw(jqayeeqvxy) = bimcseoyne pgmyropgdb (vpregpejsj, jtyvlddgel - eqguppmoig) View more	-	13 Aug 2013
				Losec (Losec)	uduwnpqquw(jqayeeqvxy) = vsdptwcpmf pgmyropgdb (vpregpejsj, rovxmccqao - enojbwpibs) View more