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

Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal Disorders

Phase 4
Conditions
Constipation-predominant Irritable Bowel Syndrome
Functional Dyspepsia
Interventions
First Posted Date
2021-11-26
Last Posted Date
2021-12-13
Lead Sponsor
RenJi Hospital
Target Recruit Count
78
Registration Number
NCT05134584
Locations
🇨🇳

RenJiH, Shanghai, Shanghai, China

Study of the Effect of Food and a Proton Pump Inhibitor (PPI; Omeprazole) on LOXO-305 in Healthy Participants

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
First Posted Date
2021-11-24
Last Posted Date
2025-01-10
Lead Sponsor
Loxo Oncology, Inc.
Target Recruit Count
10
Registration Number
NCT05134350
Locations
🇺🇸

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

A Study of the Drug Interactions Between Danicopan and Cyclosporine, Tacrolimus, Antacids, and Omeprazole in Healthy Adults

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2021-11-05
Last Posted Date
2021-11-05
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
72
Registration Number
NCT05109390
Locations
🇺🇸

Clinical Trial Site, Tempe, Arizona, United States

A Study to Estimate the Effect of Multiple Dose Abrocitinib on Caffeine, Efavirenz, and Omeprazole in Healthy Participants

Phase 1
Completed
Conditions
Healthy Participants
Interventions
First Posted Date
2021-10-05
Last Posted Date
2024-05-31
Lead Sponsor
Pfizer
Target Recruit Count
26
Registration Number
NCT05067439
Locations
🇺🇸

Research Centers of America ( Hollywood ), Hollywood, Florida, United States

A Study to Assess the Effects of Itraconazole, Rifampicin, and Omeprazole on Pharmacokinetics of Adavosertib

Phase 1
Terminated
Conditions
Advanced Solid Tumours
Interventions
First Posted Date
2021-07-13
Last Posted Date
2022-09-16
Lead Sponsor
AstraZeneca
Target Recruit Count
5
Registration Number
NCT04959266
Locations
🇪🇸

Research Site, Malaga, Spain

High Dose Omeprazole in Patients With Pancreatic Cancer

Early Phase 1
Recruiting
Conditions
Exocrine Pancreatic Cancer
Interventions
First Posted Date
2021-06-18
Last Posted Date
2025-05-16
Lead Sponsor
University of Oklahoma
Target Recruit Count
60
Registration Number
NCT04930991
Locations
🇺🇸

Stephenson Cancer Center, Oklahoma City, Oklahoma, United States

A Study to Evaluate the One-way Interaction of Calcium Carbonate, Omeprazole, or Rifampin on ACP-196

Phase 1
Completed
Conditions
Healthy Participants
Interventions
First Posted Date
2021-06-07
Last Posted Date
2021-06-07
Lead Sponsor
Acerta Pharma BV
Target Recruit Count
72
Registration Number
NCT04914936

Vonoprazan in Helicobacter Pylori Treatment an RCT

First Posted Date
2021-05-25
Last Posted Date
2021-08-18
Lead Sponsor
Dow University of Health Sciences
Target Recruit Count
179
Registration Number
NCT04901663
Locations
🇵🇰

Dr Ruth KM Pfau Civil Hospital Karachi, Karachi, Sindh, Pakistan

A Study to Evaluate the Effect of an Acidic Formulation of Acalabrutinib (ACP-196), Acidic Beverage, or Grapefruit Juice on the Pharmacokinetics (PK) of ACP-196 Alone and Coadministered With Omeprazole

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
First Posted Date
2021-05-07
Last Posted Date
2021-05-07
Lead Sponsor
Acerta Pharma BV
Target Recruit Count
36
Registration Number
NCT04876807
Locations
🇺🇸

Laura Sterling, MD, MPH, Lincoln, Nebraska, United States

A Study of LY3484356 in Healthy Female Participants

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2021-04-12
Last Posted Date
2022-05-02
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
82
Registration Number
NCT04840888
Locations
🇺🇸

LabCorp CRU, Inc., Daytona Beach, Florida, United States

🇺🇸

Covance Dallas, Dallas, Texas, United States

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