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

GERD Infant Feeding Therapeutics Trial (GIFT Trial)

Not Applicable

Recruiting

Conditions: GERD in Infants

Interventions: Drug: Omeprazole
Other: AR formula

First Posted Date: 2023-11-02

Last Posted Date: 2024-10-04

Lead Sponsor: Nationwide Children's Hospital

Target Recruit Count: 369

Registration Number: NCT06114836

Locations: 🇺🇸
Nationwide Children's Hospita, Columbus, Ohio, United States

Effect of Omeprazole on Pharmacokinetics of SHR2554 in Healthy Subjects

Phase 1

Completed

Conditions: Malignant Tumor

Interventions: Drug: SHR2554 tablet dosing
Drug: Omeprazole tablet dosing

First Posted Date: 2023-10-23

Last Posted Date: 2023-12-05

Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Target Recruit Count: 20

Registration Number: NCT06093945

Locations: 🇨🇳
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China

Drug-durg Interaction of Leritrelvir(RAY1216) With Midazolam, Omeprazole, Rosuvastatin, Verapamil, and Rifampin

Phase 1

Completed

Conditions: Drug Drug Interaction

Interventions: Drug: Midazolam
Drug: Verapamil
Drug: Omeprazole
Drug: Rifampin
Drug: Rosuvastatin
Drug: Leritrelvir

First Posted Date: 2023-09-11

Last Posted Date: 2024-04-16

Lead Sponsor: Guangdong Raynovent Biotech Co., Ltd

Target Recruit Count: 56

Registration Number: NCT06031454

Locations: 🇨🇳
the Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China

Voxelotor CYP and Transporter Cocktail Interaction Study

Phase 1

Completed

Conditions: Sickle Cell Disease

Interventions: Drug: Voxelotor
Drug: Bupropion
Drug: Metformin
Drug: Repaglinide
Drug: Furosemide
Drug: Rosuvastatin
Drug: Flurbiprofen
Drug: Omeprazole
Drug: Midazolam

First Posted Date: 2023-08-08

Last Posted Date: 2024-11-22

Lead Sponsor: Pfizer

Target Recruit Count: 44

Registration Number: NCT05981365

Locations: 🇺🇸
ICON Early Phase Services, LLC, San Antonio, Texas, United States

A Study to Assess the Effect of BMS-986419 on the Single Dose Drug Levels of Probe Substrates in Healthy Participants

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: BMS-986419
Drug: Caffeine
Drug: Bupropion
Drug: Flurbiprofen
Drug: Omeprazole
Drug: Midazolam
Drug: Fexofenadine

First Posted Date: 2023-07-06

Last Posted Date: 2023-10-30

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 22

Registration Number: NCT05932277

Locations: 🇺🇸
ICON Lenexa, Lenexa, Kansas, United States

Study to Investigate the Effect of Rocatinlimab (AMG 451) on the Pharmacokinetics of Multiple Cytochrome P450 (CYP450) Substrates in Participants With Moderate to Severe Atopic Dermatitis

Early Phase 1

Completed

Conditions: Atopic Dermatitis

Interventions: Dietary Supplement: Caffeine
Drug: Metoprolol
Drug: Midazolam
Drug: Warfarin
Dietary Supplement: Vitamin K
Drug: Omeprazole
Drug: Rocatinlimab

First Posted Date: 2023-06-06

Last Posted Date: 2025-01-20

Lead Sponsor: Amgen

Target Recruit Count: 21

Registration Number: NCT05891119

Locations: 🇺🇸
Direct Helpers Research Center (DHRC), Hialeah, Florida, United States
🇺🇸
Velocity Clinical Research -Spartanburg, Spartanburg, South Carolina, United States
🇺🇸
DermDox Dermatology Centers, PC - Sugarloaf, Nashville, Tennessee, United States

and more 4 locations