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: C_₁₇H_₁₉N_₃O_₃S

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: -

Clinical Trials

Anti-reflux Control to Decrease Post Tonsillectomy Pain

Phase 4

Terminated

Conditions: Laryngopharyngeal Reflux
Throat Pain

Interventions: Drug: Omeprazole

First Posted Date: 2013-01-29

Last Posted Date: 2018-10-24

Lead Sponsor: Ascension Health

Target Recruit Count: 6

Registration Number: NCT01777854

Locations: 🇺🇸
Genesys Regional Medical Center, Grand Blanc, Michigan, United States

Study to Evaluate Effect of Belatacept on Pharmacokinetics of Inje Cocktail in Healthy Volunteers

Phase 4

Completed

Conditions: Transplant Rejection

Interventions: Drug: Caffeine
Drug: Losartan
Drug: Omeprazole
Drug: Dextromethorphan
Drug: Midazolam
Biological: Belatacept

First Posted Date: 2013-01-11

Last Posted Date: 2014-06-27

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 45

Registration Number: NCT01766050

Locations: 🇺🇸
Healthcare Discoveries, Llc D/B/A Icon Development Solutions, San Antonio, Texas, United States

Omeprazole and Pantoprazole Antiplatelet Effect of Clopidogrel Clinical Trials(OPEN)

Phase 4

Conditions: Acute Coronary Syndromes

Interventions: Drug: omeprazole
Drug: Pantoprazole

First Posted Date: 2012-11-28

Last Posted Date: 2012-11-28

Lead Sponsor: Yaling Han

Target Recruit Count: 620

Registration Number: NCT01735227

Locations: 🇨🇳
OPEN trail, Shenyang, Liaoning, China
🇨🇳
ShenyangNH, Shenyang, Liaoning, China

Effect of Omeprazole on Metformin

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Placebo
Drug: Omeprazole

First Posted Date: 2012-10-22

Last Posted Date: 2013-03-19

Lead Sponsor: Xijing Hospital

Target Recruit Count: 20

Registration Number: NCT01711320

Locations: 🇨🇳
Department of pharmacy, Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi, China

A Three-Period Study to Investigate the Relative Bioavailability and Pharmacodynamic Profiles of a Zegerid 20mg Capsule, Zegerid 20mg Powder for Oral Suspension and Losec 20mg Capsule in Healthy Adult Volunteers Under Fasting Conditions

Phase 1

Completed

Conditions: Acid Reflux
Gastro Oesophageal Reflux Disease

Interventions: Drug: Losec
Drug: Zegerid

First Posted Date: 2012-10-19

Last Posted Date: 2012-10-19

Lead Sponsor: Norgine

Target Recruit Count: 20

Registration Number: NCT01710995

Locations: 🇬🇧
Bio-Kinetic Europe Limited, 14 Great Victoria Street, Belfast BT2 7BA, Belfast, United Kingdom

Investigation of Food Effect and Gastric ph Increase on the Bioavailability of Faldapravir

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: faldaprevir
Drug: omeprazole

First Posted Date: 2012-09-27

Last Posted Date: 2015-07-30

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 15

Registration Number: NCT01694706

Locations: 🇩🇪
1220.59.1 Boehringer Ingelheim Investigational Site, Biberach, Germany

Management of Myocardial Injury After Noncardiac Surgery Trial

Phase 3

Completed

Conditions: Myocardial Injury After Noncardiac Surgery (MINS)

Interventions: Drug: Placebo (for Dabigatran)
Drug: Placebo (for Omeprazole)
Drug: Dabigatran
Drug: Omeprazole

First Posted Date: 2012-08-09

Last Posted Date: 2018-03-26

Lead Sponsor: Population Health Research Institute

Target Recruit Count: 1754

Registration Number: NCT01661101

Locations: 🇵🇪
Hospital Nacional Cayetano Heredia, Lima, Peru
🇦🇷
Instituto Cardiovascular de Buenos Aires, Caba, Buenos Aires, Argentina
🇦🇷
Clinica Parra - Centro de Investigaciones, Rafaela, Santa Fe, Argentina

and more 79 locations