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

Clinical Trials

Fatty Acid Synthase Inhibition in Castration Refractory Prostate Cancer

Phase 2

Recruiting

Conditions: Castration Resistant Prostatic Cancer
Prostate Cancer
Refractory Cancer

Interventions: Drug: Omeprazole 80 mg twice daily

First Posted Date: 2020-04-07

Last Posted Date: 2025-02-12

Lead Sponsor: Wake Forest University Health Sciences

Target Recruit Count: 20

Registration Number: NCT04337580

Locations: 🇺🇸
Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
🇺🇸
W.G. Bill Hefner VA Medical Center, Salisbury, North Carolina, United States

Preventing Cardiac Complication of COVID-19 Disease With Early Acute Coronary Syndrome Therapy: A Randomised Controlled Trial.

Not Applicable

Terminated

Conditions: COVID-19

Interventions: Drug: Aspirin 75mg
Drug: Clopidogrel 75mg
Drug: Rivaroxaban 2.5 MG
Drug: Atorvastatin 40mg
Drug: Omeprazole 20mg

First Posted Date: 2020-04-03

Last Posted Date: 2023-01-18

Lead Sponsor: Imperial College London

Target Recruit Count: 320

Registration Number: NCT04333407

Locations: 🇬🇧
Charing Cross Hospital, London, United Kingdom

Study in Subjects With Rheumatoid Arthritis to Evaluate the Effect of a Single Dose of Olokizumab on the Pharmacokinetics of Substrates for CYP1A2, CYP2C9, CYP2C19 and CYP3A4

Phase 1

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: Olokizumab
Drug: Omeprazole
Drug: Caffeine
Drug: Warfarin+ Vitamin K
Drug: Midazolam

First Posted Date: 2020-01-29

Last Posted Date: 2024-08-15

Lead Sponsor: R-Pharm International, LLC

Target Recruit Count: 17

Registration Number: NCT04246762

Locations: 🇧🇬
Comac Medical Ltd, Sofia, Bulgaria
🇲🇩
ICS ARENSIA Exploratory Medicine SRL, a daughter company of ARENSIA Exploratory Medicine GmbH,Republican Clinical Hospital, Chisinau, Moldova, Republic of

Assessment of Gastric pH Changes Induced by Ascorbic Acid Tablets

Phase 1

Active, not recruiting

Conditions: Hypochlorhydria

Interventions: Drug: Omeprazole 20mg
Dietary Supplement: Vitamin C

First Posted Date: 2019-12-16

Last Posted Date: 2024-08-15

Lead Sponsor: Indiana University

Target Recruit Count: 11

Registration Number: NCT04199624

Locations: 🇺🇸
Indiana University School of Medicine, Indianapolis, Indiana, United States

Interaction Between Omeprazole and Gliclazide in CYP2C19 Normal/ Ultrarapid Metabolisers

Phase 1

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Omeprazole
Drug: Placebo oral tablet
Drug: Gliclazide

First Posted Date: 2019-12-13

Last Posted Date: 2021-08-18

Lead Sponsor: University of Sarajevo

Target Recruit Count: 15

Registration Number: NCT04198948

Locations: 🇧🇦
General Hospital Prim. Dr. Abdulah Nakas, Sarajevo, Bosnia and Herzegovina

Oral Omeprazole in Bleeding Peptic Ulcer

Early Phase 1

Conditions: Bleeding Peptic Ulcer

Interventions: Drug: Omeprazole

First Posted Date: 2019-11-20

Last Posted Date: 2019-11-25

Lead Sponsor: Assiut University

Target Recruit Count: 100

Registration Number: NCT04170270

Argon Plasma Coagulation for Barrett's Esophagus

Not Applicable

Completed

Conditions: Barretts Esophagus With Low Grade Dysplasia

Interventions: Device: Argon Plasma Coagulation 90W power
Device: Argon Plasma Coagulation 60W power
Drug: Omeprazole 40 mg
Drug: Omeprazole 120 mg