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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

Evaluating the Effects of Omeprazole on the Pharmacokinetics of XS004 (Dasatinib) Tablets in Healthy Adult Subjects Under Fasting Conditions

Phase 1
Completed
Conditions
Pharmacokinetics
Drug Interactions
Interventions
First Posted Date
2022-06-27
Last Posted Date
2022-06-27
Lead Sponsor
Xspray Pharma AB
Target Recruit Count
17
Registration Number
NCT05433896
Locations
🇺🇸

AXIS Clinicals, Dilworth, Minnesota, United States

A Pharmacokinetic Study to Evaluate the Drug Interaction Between SHR0302 and CYP Substrates in Healthy Volunteers

First Posted Date
2022-05-26
Last Posted Date
2022-12-22
Lead Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Target Recruit Count
24
Registration Number
NCT05392127
Locations
🇨🇳

Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China

High Dose Dual Therapy vs Clarithromycin Triple Therapy for Treatment Naive H Pylori Infection in an Urban Population

Phase 4
Completed
Conditions
Helicobacter Pylori Infection
Interventions
First Posted Date
2022-04-22
Last Posted Date
2023-02-01
Lead Sponsor
Icahn School of Medicine at Mount Sinai
Target Recruit Count
112
Registration Number
NCT05342532
Locations
🇺🇸

Mount Sinai Union Square Division of Digestive Diseases, New York, New York, United States

Study of H2 Antagonist and a Proton Pump Inhibitor of Selpercatinib in Healthy Participants

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2022-04-21
Last Posted Date
2024-10-30
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
20
Registration Number
NCT05338502
Locations
🇺🇸

Covance Clinical Research Unit, Inc., Madison, Wisconsin, United States

A Study of ALXN1840 (Coated and Non-coated) Administered With And Without Omeprazole In Healthy Adults

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: ALXN1840 Enteric-coated Tablet
Drug: ALXN1840 Non-coated Capsule
First Posted Date
2022-04-08
Last Posted Date
2023-08-02
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
18
Registration Number
NCT05319912
Locations
🇺🇸

Clinical Trial Site, Lincoln, Nebraska, United States

A Study of ALXN1840 (Non-coated) Administered With And Without Omeprazole In Healthy Adults

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2022-04-08
Last Posted Date
2023-08-01
Lead Sponsor
Alexion Pharmaceuticals, Inc.
Target Recruit Count
18
Registration Number
NCT05319899
Locations
🇺🇸

Clinical Trial Site, Lincoln, Nebraska, United States

A Pharmacokinetic Study to Evaluate the Drug Interaction Between HRS5091 and Probe Drugs in Healthy Volunteers

First Posted Date
2022-03-10
Last Posted Date
2022-12-23
Lead Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Target Recruit Count
22
Registration Number
NCT05273775
Locations
🇨🇳

The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China

Risk of CYP2C19 Phenoconversion in Healthy Volunteers With Rapid, Normal, and Intermediate Predicted Metabolizers' Status

First Posted Date
2022-03-03
Last Posted Date
2022-11-03
Lead Sponsor
University Hospital, Geneva
Target Recruit Count
45
Registration Number
NCT05264142
Locations
🇨🇭

Geneva University Hospitals, HUG, Genève, Switzerland

Biomarkers for Prediction of Analgesic Efficacy in Knee OA.

Not Applicable
Completed
Conditions
Knee, Osteoarthritis (OA)
Biomarkers for Prediction of OA Treatment Efficacy
Interventions
First Posted Date
2022-02-25
Last Posted Date
2024-04-12
Lead Sponsor
Rambam Health Care Campus
Target Recruit Count
17
Registration Number
NCT05256342
Locations
🇮🇱

Rambam Health Care Campus, Haifa, Israel

A Study to Investigate the Effect of Single and Repeated Oral Doses of ACT-539313 on What the Body Does to Flurbiprofen, Omeprazole, Midazolam in Healthy Subjects

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2022-02-24
Last Posted Date
2022-05-04
Lead Sponsor
Idorsia Pharmaceuticals Ltd.
Target Recruit Count
22
Registration Number
NCT05254548
Locations
🇩🇪

CRS Clinical Research Services Berlin GmbH, Berlin, Germany

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