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

Associated Therapies: -

Clinical Trials

Effect of G17DT in Patients With Stage II/III Colorectal Cancer

Phase 2

Completed

Conditions: Colorectal Cancer

Interventions: Biological: G17DT
Drug: Omeprazole

First Posted Date: 2015-08-07

Last Posted Date: 2015-08-07

Lead Sponsor: Cancer Advances Inc.

Target Recruit Count: 22

Registration Number: NCT02518373

The CALIBER Study Randomized Controlled Trial of LINX Versus Double-Dose Proton Pump Inhibitor Therapy for Reflux Disease

Phase 4

Completed

Conditions: GERD Gastroesophageal Reflux Disease

Interventions: Device: LINX Reflux Management System
Drug: Omeprazole

First Posted Date: 2015-07-22

Last Posted Date: 2019-01-07

Lead Sponsor: Torax Medical Incorporated

Target Recruit Count: 152

Registration Number: NCT02505945

Locations: 🇺🇸
Albert Einstein Healthcare Network, Philadelphia, Pennsylvania, United States
🇺🇸
SurgOne Foregut Institute, Englewood, Colorado, United States
🇺🇸
UCSD, San Diego, California, United States

and more 18 locations

Intensive Urate Lowering Therapy of Febuxostat Compared to Allopurinol on Cardiovascular Risk in Patients With Gout

Phase 4

Completed

Conditions: Gout

Interventions: Drug: Febuxostat 80/120mg/day
Drug: Allopurinol 100 up to 600mg/day
Drug: Colchicine
Drug: Naproxen
Drug: Omeprazole

First Posted Date: 2015-07-16

Last Posted Date: 2019-06-21

Lead Sponsor: Menarini International Operations Luxembourg SA

Target Recruit Count: 196

Registration Number: NCT02500641

Locations: 🇵🇱
Specjalistyczna Praktyka Lekarska Piotr Kubalski, Grudziądz, Poland
🇵🇱
Oddział Kardiologiczny, WSS im. W. Biegańskiego w Łodzi, Łódź, Poland
🇷🇴
S.C. Cardiomed S.R.L., Craiova, Romania

and more 23 locations

A Multiple-Dose Pharmacokinetics Study of Two Gefapixant (AF-219/MK-7264) Formulations

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Omeprazole
Drug: Gefapixant

First Posted Date: 2015-07-09

Last Posted Date: 2022-07-22

Lead Sponsor: Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Target Recruit Count: 14

Registration Number: NCT02492776

Locations: 🇺🇸
Celerion, Tempe, Arizona, United States

A PHASE 1, OPEN-LABEL, CROSS-OVER, FIXED SEQUENCE STUDY TO EVALUATE THE EFFECT OF MULTIPLE DOSES OF DS-1971A ON THE SINGLE DOSE PHARMACOKINETICS OF PROBE SUBSTRATES FOR CYP2B6, CYP2C8, CYP2C9, CYP2C19 AND CYP3A4 ENZYMES IN HEALTHY MALE AND FEMALE SUBJECTS

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: midazolam hydrochloride
Drug: DS-1971a
Drug: Omeprazole
Drug: Pioglitazone hydrochloride
Drug: Buproprion
Drug: Tolbutamide

First Posted Date: 2015-06-16

Last Posted Date: 2015-11-05

Lead Sponsor: Daiichi Sankyo

Target Recruit Count: 18

Registration Number: NCT02473627

Eradication of Antibiotic-resistant Bacteria Through Antibiotics and Fecal Bacteriotherapy

Phase 2

Conditions: Intestinal Colonization With Multidrug-resistant Bacteria

Interventions: Drug: Colistin
Drug: Neomycin
Drug: Fecal microbiota transplantation (FMT)
Drug: Omeprazole

First Posted Date: 2015-06-16

Last Posted Date: 2017-12-07

Lead Sponsor: Stephen Harbarth

Target Recruit Count: 39

Registration Number: NCT02472600

Locations: 🇫🇷
Assistance Publique-Hôpitaux de Paris, Hôpital Beaujon, Clichy, France
🇳🇱
Universitair Medisch Centrum Utrecht,, Utrecht, Netherlands
🇨🇭
Geneva University Hospitals, Geneva, Switzerland

and more 1 locations