Omeprazole

Generic Name
Omeprazole
Brand Names
Konvomep, Losec, Omeclamox, Omesec, Previdolrx Analgesic Pak, Prilosec, Talicia, Yosprala, Zegerid, Zegerid Reformulated Aug 2006, Zegerid With Magnesium Hydroxide
Drug Type
Small Molecule
Chemical Formula
C17H19N3O3S
CAS Number
73590-58-6
Unique Ingredient Identifier
KG60484QX9
Background

Originally approved by the FDA in 1989, omeprazole is a proton-pump inhibitor, used to treat gastric acid-related disorders. These disorders may include gastroesophageal reflux disease (GERD), peptic ulcer disease, and other diseases characterized by the oversecretion of gastric acid. This drug was the first clinical useful drug in its class, and its approval was followed by the formulation of many other proton pump inhibitor drugs . Omeprazole is generally effective and well-tolerated, promoting its popular use in children and adults .

Indication

Omeprazole, according to the FDA label is a proton pump inhibitor (PPI) used for the following purposes:

• Treatment of active duodenal ulcer in adults

• Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer

recurrence in adults

• Treatment of active benign gastric ulcer in adults

• Reduction of risk of upper gastrointestinal (GI) bleeding in critically ill adult patients.

• Treatment of symptomatic gastroesophageal reflux disease (GERD) in

patients 1 year of age and older

• Treatment of erosive esophagitis (EE) due to acid-mediated GERD in

patients 1 month of age and older

• Maintenance of healing of EE due to acid-mediated GERD in patients 1

year of age and older

• Pathologic hypersecretory conditions in adults

Associated Conditions
Ankylosing Spondylitis (AS), Duodenal Ulcer, Erosive Esophagitis, Gastric Ulcer, Gastro-esophageal Reflux Disease (GERD), Healing, Heartburn, Helicobacter Pylori Infection, Osteoarthritis (OA), Rheumatoid Arthritis, Upper GI Bleeding, Zollinger-Ellison Syndrome, Benign, active Gastric Ulcer, Develop NSAID-induced gastric ulcers, Hypersecretory conditions, Multiple endocrine adenomas
Associated Therapies
-

Influence of CYP2C19 Polymorphism on PK/PD of Omeprazole

Phase 1
Completed
Conditions
Interventions
First Posted Date
2014-11-24
Last Posted Date
2015-01-01
Lead Sponsor
Seoul National University Hospital
Target Recruit Count
24
Registration Number
NCT02299687
Locations
🇰🇷

Seoul National University Hospital, Seoul, Korea, Republic of

DLBS2411 Treatment for Ulcer Healing in Non-Bleeding Peptic Ulcers

First Posted Date
2014-10-10
Last Posted Date
2019-07-09
Lead Sponsor
Dexa Medica Group
Target Recruit Count
32
Registration Number
NCT02262169
Locations
🇮🇩

Division of Gastroenterohepatology Department of Internal Medicine Faculty of Medicine, University of Udayana Sanglah General Hospital, Denpasar, Bali, Indonesia

The Effect of BI 187004 on the Pharmacokinetics of Cytochrome P450 Substrates (Caffeine, Warfarin, Omeprazole, Metoprolol and Midazolam) and a P Glycoprotein Substrate (Digoxin)

First Posted Date
2014-10-01
Last Posted Date
2014-12-23
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
24
Registration Number
NCT02254148
Locations
🇩🇪

1307.19.1 Boehringer Ingelheim Investigational Site, Biberach, Germany

Investigating the Influence of Omeprazole on the Pharmacokinetics of Oral Semaglutide in Healthy Subjects

Phase 1
Completed
Conditions
Interventions
First Posted Date
2014-09-26
Last Posted Date
2018-08-13
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
54
Registration Number
NCT02249871
Locations
🇩🇪

Novo Nordisk Investigational Site, Berlin, Germany

A Phase 1 Study to Examine the Pharmacodynamics of Different AZD1722 Formulations

Phase 1
Completed
Conditions
Interventions
First Posted Date
2014-09-26
Last Posted Date
2014-09-26
Lead Sponsor
Ardelyx
Target Recruit Count
18
Registration Number
NCT02249936
Locations
🇺🇸

ICON Development Solutions, Omaha, Nebraska, United States

A Study to Assess the Effects of Single Ascending Doses (SAD) of ASP8477, the Effect That Food Has on the Drug, and the Interaction Between ASP8477 and Omeprazole in Healthy Postmenopausal Females and Healthy Young Vasectomized Males

First Posted Date
2014-08-20
Last Posted Date
2014-08-20
Lead Sponsor
Astellas Pharma Europe B.V.
Target Recruit Count
72
Registration Number
NCT02220777
Locations
🇧🇪

SGS Belgium N.V., Antwerp, Belgium

🇫🇷

SGS Aster, Paris, France

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