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

The Role of HRM and Specific Biomarkers of Inflammation in the Diagnosis of Patients With Dysphagia and Suspected EoE

Conditions: Eosinophilic Esophagitis

Interventions: Diagnostic Test: High-resolution manometry
Diagnostic Test: Serum biomarkers
Diagnostic Test: Gastrointestinal Quality of Life index
Drug: Omeprazole 20 MG Oral Tablet

First Posted Date: 2021-03-17

Last Posted Date: 2021-03-17

Lead Sponsor: Wroclaw Medical University

Target Recruit Count: 58

Registration Number: NCT04803162

Locations: 🇵🇱
Department of Gastroenterology and Hepatology, Wroclaw Medical University, Wrocław, Borowska 213, Poland

PROUD Study - Preventing Opioid Use Disorders

Phase 4

Terminated

Conditions: Opioid Use
Anesthesia

Interventions: Behavioral: Guided mindfulness exercises
Other: Self-administered aromatherapy
Drug: Baby aspirin
Drug: Tylenol/Acetaminophen
Drug: Pregabalin
Drug: Prednisone
Drug: Meloxicam
Drug: Prilosec
Drug: Tramadol
Drug: Voltaren
Drug: Zofran
Drug: Pepcid
Drug: Reglan
Drug: Versed
Drug: Lidocaine
Drug: Propofol
Drug: Ancef
Drug: Tranexamic Acid (TXA)
Drug: Decadron
Drug: Bupivacaine hydrochloride
Drug: Toradol

First Posted Date: 2021-02-23

Last Posted Date: 2023-06-22

Lead Sponsor: Emory University

Target Recruit Count: 57

Registration Number: NCT04766996

Locations: 🇺🇸
Emory University Orthopaedic and Spine Hospital, Atlanta, Georgia, United States

Bioavailability and Bioequivalence of Two Risdiplam Tablets in Healthy Participants

Phase 1

Completed

Conditions: Muscular Atrophy, Spinal

Interventions: Drug: risdiplam
Drug: omeprazole

First Posted Date: 2021-01-22

Last Posted Date: 2023-03-13

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 131

Registration Number: NCT04718181

Locations: 🇺🇸
Dallas Clinical Research Unit, Dallas, Texas, United States
🇺🇸
Daytona Beach Clinical Rsch Unit, Daytona Beach, Florida, United States
🇺🇸
Covance Clinical Research Unit, Inc, Madison, Wisconsin, United States

and more 1 locations

Efficacy and Safety of Houtou Jianweiling Tablet in the Treatment of Chronic Non-Atrophic Gastritis

Phase 2

Completed

Conditions: Gastritis

Interventions: Other: Houtou Jianweiling tablet
Drug: Omeprazole Tablet

First Posted Date: 2020-12-17

Last Posted Date: 2023-04-18

Lead Sponsor: University of Karachi

Target Recruit Count: 240

Registration Number: NCT04672018

Locations: 🇵🇰
Center for Bioequivalence Studies and Clinical Research (CBSCR), ICCBS, university of Karachi, Karachi, Pakistan

Drug-drug Interaction Study of KL1333 in Healthy Subjects

Phase 1

Completed

Conditions: Mitochondrial Disease

Interventions: Drug: KL1333
Drug: Flurbiprofen
Drug: Dextromethorphan
Drug: Bupropion
Drug: Midazolam injection
Drug: Omeprazole
Drug: Caffeine
Drug: Repaglinide

First Posted Date: 2020-11-25

Last Posted Date: 2021-10-20

Lead Sponsor: Abliva AB

Target Recruit Count: 14

Registration Number: NCT04643249

Locations: 🇬🇧
Volunteer recruitment center Covance Leeds Covance Leeds, Leeds, United Kingdom

Assessment and Management of Chronic Dyspepsia in Eastern Uganda

Early Phase 1

Completed

Conditions: Dyspepsia
Helicobacter Pylori Infection

Interventions: Drug: Clarithromycin 500mg
Drug: Omeprazole 20 MG Oral Tablet
Drug: Amoxicillin 1000 MG
Drug: Omeprazole 40 MG

First Posted Date: 2020-08-25

Last Posted Date: 2020-08-25

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 376

Registration Number: NCT04525664

Locations: 🇺🇸
Washington University in St. Louis School of Medicine, Saint Louis, Missouri, United States

Metformin's Effect on Drug Metabolism in Patients With Type 2 Diabetes

Phase 1

Terminated

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Metformin
Drug: Caffeine
Drug: Efavirenz
Drug: Losartan
Drug: Omeprazol
Drug: Metoprolol
Drug: Midazolam

First Posted Date: 2020-08-07

Last Posted Date: 2022-06-16

Lead Sponsor: University of Southern Denmark

Target Recruit Count: 10

Registration Number: NCT04504045

Locations: 🇩🇰
University of Southern Denmark, Odense, Region Of Southern Denmark, Denmark

Evaluation of Pharmacokinetic Interaction Between GSK3640254 and Caffeine, Metoprolol, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin in Healthy Adults

Phase 1

Completed

Conditions: HIV Infections

Interventions: Drug: GSK3640254 200 mg
Drug: Caffeine 200 mg
Drug: Metoprolol 100 mg
Drug: Montelukast 10 mg
Drug: Flurbiprofen 100 mg
Drug: Omeprazole 40 mg
Drug: Midazolam 5 mg (2.5 mL)
Drug: Digoxin 0.25 mg
Drug: Pravastatin 40 mg

First Posted Date: 2020-06-11

Last Posted Date: 2024-01-05

Lead Sponsor: ViiV Healthcare

Target Recruit Count: 20

Registration Number: NCT04425902

Locations: 🇺🇸
GSK Investigational Site, Las Vegas, Nevada, United States

High Dose Oral Omeprazole in High Risk UGIB

Not Applicable

Recruiting

Conditions: GI Bleeding

Interventions: Drug: Standard IV PPI
Drug: High-dose oral omeprazole

First Posted Date: 2020-05-19

Last Posted Date: 2022-08-26

Lead Sponsor: King Chulalongkorn Memorial Hospital

Target Recruit Count: 76

Registration Number: NCT04394663

Locations: 🇹🇭
Rapat Pittayanon, Pathum Wan, Bangkok, Thailand

Study to Examine the Effect of Antacid and Omeprazole on the Single-Dose Pharmacokinetics of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Tebipenem pivoxil hydrobromide (TBPM-PI-HBr)
Drug: 20 mL aluminum hydroxide/magnesium hydroxide/simethicone (400 mg aluminum hydroxide/400 mg magnesium hydroxide/40 mg simethicone per 5 mL)
Drug: Omeprazole

First Posted Date: 2020-04-30

Last Posted Date: 2020-09-04

Lead Sponsor: Spero Therapeutics

Target Recruit Count: 20

Registration Number: NCT04368585

Locations: 🇺🇸
Medical Facility, Phoenix, Arizona, United States

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