MedPath

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

The Possible Protective Role of Omeprazole Against Oxaliplatin Induced Neuropathy in Cancer Patients

Phase 3
Not yet recruiting
Conditions
Chemotherapy Induced Peripheral Neuropathy
Interventions
First Posted Date
2023-01-11
Last Posted Date
2023-01-11
Lead Sponsor
Aya Mohamed Sadek Elsaid
Target Recruit Count
46
Registration Number
NCT05680870

Evaluation of the Effects of Omeprazole and Rifampin on the Pharmacokinetics of VX-548 in Healthy Participants

Phase 1
Completed
Conditions
Pain
Interventions
First Posted Date
2022-12-02
Last Posted Date
2024-03-20
Lead Sponsor
Vertex Pharmaceuticals Incorporated
Target Recruit Count
31
Registration Number
NCT05635110
Locations
🇦🇺

CMAX Clinical Research, Adelaide, Australia

A Study to Evaluate the Impact of Acid-reducing Agents on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants

Phase 1
Completed
Conditions
Healthy Participants
Interventions
First Posted Date
2022-10-31
Last Posted Date
2024-12-12
Lead Sponsor
Amgen
Target Recruit Count
14
Registration Number
NCT05599828
Locations
🇺🇸

Covance Clinical Research Unit, Inc, Dallas, Texas, United States

Study to Evaluate the Drug-drug Interaction Effect of Omeprazole on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants

Phase 1
Completed
Conditions
Healthy Participants
Interventions
First Posted Date
2022-10-17
Last Posted Date
2025-03-18
Lead Sponsor
Amgen
Target Recruit Count
14
Registration Number
NCT05581992
Locations
🇺🇸

Covance Clinical Research Unit, Inc, Daytona Beach, Florida, United States

A Study to Evaluate the Impact of Lactobacillus Rhamnosus GG on Proton Pump Inhibitor-Induced Gut Dysbiosis

Not Applicable
Recruiting
Conditions
Healthy
Interventions
Dietary Supplement: Lactobacillus rhamnosus GG
Drug: Placebo
First Posted Date
2022-08-26
Last Posted Date
2025-03-17
Lead Sponsor
Mayo Clinic
Target Recruit Count
30
Registration Number
NCT05517928
Locations
🇺🇸

Mayo Clinic Arizona, Scottsdale, Arizona, United States

A Study to Evaluate the Impact of Omeprazole on the Pharmacokinetics of Sotorasib Co-administered With an Acidic Beverage in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
First Posted Date
2022-08-11
Last Posted Date
2024-01-19
Lead Sponsor
Amgen
Target Recruit Count
16
Registration Number
NCT05497557
Locations
🇺🇸

Labcorp Clinical Research Unit Inc., Dallas, Texas, United States

A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

Phase 1
Active, not recruiting
Conditions
Advanced Solid Tumors
Metastatic Solid Tumors
Interventions
First Posted Date
2022-08-04
Last Posted Date
2025-03-25
Lead Sponsor
Genentech, Inc.
Target Recruit Count
232
Registration Number
NCT05487235
Locations
🇦🇷

Sanatorio Allende, Cordoba, Argentina

🇦🇷

Fundacion CORI para la Investigacion y Prevencion del Cancer, La Rioja, Argentina

🇦🇷

Centro Medico IPAM, Rosario, Argentina

and more 23 locations

A Study of Effect of Food and a Proton Pump Inhibitor on Selpercatinib (LY3527723) in Healthy Participants

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2022-07-21
Last Posted Date
2022-07-21
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
19
Registration Number
NCT05468164
Locations
🇺🇸

Celerion, Tempe, Arizona, United States

A Study of Imlunestrant (LY3484356) in Female Healthy Participants

First Posted Date
2022-07-06
Last Posted Date
2022-11-25
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
113
Registration Number
NCT05444556
Locations
🇺🇸

Altasciences Clinical Los Angeles, Inc, Cypress, California, United States

🇺🇸

Qps-Mra, Llc, South Miami, Florida, United States

🇺🇸

ICON Early Phase Services, San Antonio, Texas, United States

Study to Assess the Effect of Co-Administration of AZD9833 on the Pharmacokinetics of Midazolam, of Omeprazole, of Celecoxib and of Dabigatran Etexilate in Healthy Postmenopausal Female Volunteers

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
First Posted Date
2022-06-29
Last Posted Date
2023-01-12
Lead Sponsor
AstraZeneca
Target Recruit Count
59
Registration Number
NCT05438303
Locations
🇺🇸

Research Site, Berlin, New Jersey, United States

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