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

A Study in Healthy Men to Test Whether Zongertinib Affects How 3 Other Medicines (Midazolam, Omeprazole, and Repaglinide) Are Taken up and Processed by the Body

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2024-07-10
Last Posted Date
2024-11-13
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
16
Registration Number
NCT06494761
Locations
🇩🇪

Humanpharmakologisches Zentrum Biberach, Biberach, Germany

Reducing Gastrointestinal Bleeding With Proton Pump Inhibitor Therapy in Acute Venous Thromboembolism

Phase 3
Not yet recruiting
Conditions
Venous Thromboembolism
Gastro Intestinal Bleeding
Blood Clot
Interventions
First Posted Date
2024-05-01
Last Posted Date
2024-05-01
Lead Sponsor
Deborah Siegal
Target Recruit Count
360
Registration Number
NCT06393868

A Study Investigating the Change in Metabolism Phenotype in Paediatric, Adolescent & Young Adults With Hodgkin or Non-Hodgkin Lymphoma.

Phase 1
Not yet recruiting
Conditions
Hodgkin Lymphoma
Non Hodgkin Lymphoma
First Posted Date
2024-04-25
Last Posted Date
2024-08-28
Lead Sponsor
Murdoch Childrens Research Institute
Target Recruit Count
10
Registration Number
NCT06383338
Locations
🇦🇺

Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

A Trial of Omeprazole and Low Dose Aspirin to Identify Colorectal Biomarkers of Preventive Efficacy

Early Phase 1
Recruiting
Conditions
Colorectal Neoplasia
Interventions
First Posted Date
2024-04-22
Last Posted Date
2025-04-10
Lead Sponsor
University of Michigan Rogel Cancer Center
Target Recruit Count
24
Registration Number
NCT06378398
Locations
🇺🇸

The University of Michigan Rogel Cancer Center, Ann Arbor, Michigan, United States

🇺🇸

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

A Clinical Trial to Evaluate a High-Fat Meal and Omeprazole Enteric-coated Tablets on ASBK021

Phase 1
Completed
Conditions
Healthy Subjects
Interventions
First Posted Date
2024-03-21
Last Posted Date
2025-02-18
Lead Sponsor
Abbisko Therapeutics Co, Ltd
Target Recruit Count
36
Registration Number
NCT06322706
Locations
🇨🇳

Wuxi People's Hospital, Wuxi, JiangShu, China

Safety and Efficacy of Triple and Quadruple Regimens as First Line Therapy for Management of Helicobacter Pylori Infection in Egyptians

First Posted Date
2024-03-18
Last Posted Date
2024-03-18
Lead Sponsor
Helwan University
Target Recruit Count
60
Registration Number
NCT06315478
Locations
🇪🇬

Badr hospital, Cairo, Egypt

A Study to Learn How Different Amounts of PF-06954522 Are Tolerated and Act in Adults With Type 2 Diabetes Mellitus

Phase 1
Active, not recruiting
Conditions
Type 2 Diabetes Mellitus (T2DM)
Obesity
Interventions
First Posted Date
2024-02-28
Last Posted Date
2025-02-13
Lead Sponsor
Pfizer
Target Recruit Count
45
Registration Number
NCT06279234
Locations
🇺🇸

Anaheim Clinical Trials, LLC, Anaheim, California, United States

🇺🇸

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

A Study of Effect of Multiple Doses of LOXO-305 on the Pharmacokinetics of Single Oral Doses of CYP1A2, CYP2C9, CYP2C19 Substrates in Healthy Participants

First Posted Date
2024-01-22
Last Posted Date
2025-03-10
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
16
Registration Number
NCT06215430
Locations
🇺🇸

Covance Clinical Research Unit, Dallas, Texas, United States

A Clinical Trial to Evaluate JAB-21822 Drug-drug Interactions in Healthy Subjects

First Posted Date
2023-12-08
Last Posted Date
2025-04-04
Lead Sponsor
Allist Pharmaceuticals, Inc.
Target Recruit Count
66
Registration Number
NCT06162169
Locations
🇨🇳

Beijing GoBroad Hospital, Beijing, Beijing, China

Ketorolac and Pregabalin Effects on breaSt Cancer (KePreSt)

Phase 2
Not yet recruiting
Conditions
Early-stage Breast Cancer
Estrogen-receptor-positive Breast Cancer
Interventions
First Posted Date
2023-11-29
Last Posted Date
2025-02-28
Lead Sponsor
Jules Bordet Institute
Target Recruit Count
112
Registration Number
NCT06150898
Locations
🇧🇪

Imane Bachir, Brussels, Belgium

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