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 approva...

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
...

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

Validation Study of Multiple Probe Compounds for Drug Interaction Evaluation

Phase 1

Completed

Conditions: Drug Interactions

Interventions: Drug: Caffeine
Drug: Ketoconazole
Drug: Rosiglitazone
Drug: Fluconazole
Drug: Flurbiprofen
Drug: Rifampin
Drug: Omeprazole
Drug: Dextromethorphan
Drug: Midazolam
Drug: Rosuvastatin

First Posted Date: 2009-08-24

Last Posted Date: 2018-01-04

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 87

Registration Number: NCT00964106

Locations: 🇰🇷
GSK Investigational Site, Seoul, Korea, Republic of

GSK1349572 Proton Pump Inhibitor Drug Interaction and Supratherapeutic Dose Study

Phase 1

Completed

Conditions: Healthy Volunteer

Interventions: Drug: GSK1349572
Drug: Placebo
Drug: Omeprazole

First Posted Date: 2009-07-20

Last Posted Date: 2009-10-09

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 24

Registration Number: NCT00942136

Locations: 🇺🇸
GSK Investigational Site, Baltimore, Maryland, United States

Effect of Vecam 40/300 and Vecam 20/300 Compared to Omeprazole 20 mg on Gastric pH

Phase 1

Completed

Conditions: Gastroesophageal Reflux

Interventions: Drug: Vecam
Drug: Omeprazole

First Posted Date: 2009-01-08

Last Posted Date: 2010-01-27

Lead Sponsor: Vecta Ltd.

Target Recruit Count: 60

Registration Number: NCT00818870

Locations: 🇺🇸
Clinical Applications Laboratories Inc., San Diego, California, United States

Bronchial Hyper-responsiveness in Reflux Cough

Phase 3

Terminated

Conditions: Cough

Interventions: Drug: Omeprazole
Drug: Ranitidine

First Posted Date: 2008-04-29

Last Posted Date: 2019-07-23

Lead Sponsor: Hull University Teaching Hospitals NHS Trust

Target Recruit Count: 5

Registration Number: NCT00668317

Locations: 🇬🇧
Clinical Trials Unit , Cardiovascular and respiratory studies, Castle Hill Hospital, Cottingham, East Yorkshire, United Kingdom

Quality of Life Validation in Laryngitis

Phase 4

Completed

Conditions: Laryngopharyngeal Reflux (LPR)

First Posted Date: 2008-03-24

Last Posted Date: 2009-06-11

Lead Sponsor: AstraZeneca

Target Recruit Count: 90

Registration Number: NCT00641264

Reflux Esophagitis Phase III Study (Initial Treatment)

Phase 3

Completed

Conditions: Reflux Esophagitis

Interventions: Drug: Esomeprazole
Drug: Omeprazole

First Posted Date: 2008-03-12

Last Posted Date: 2010-12-20

Lead Sponsor: AstraZeneca

Target Recruit Count: 602

Registration Number: NCT00633932

Locations: 🇯🇵
Research Site, Tottori, Japan

Reflux Esophagitis Phase III Study (Maintenance Treatment)

Phase 3

Completed

Conditions: Reflux Esophagitis

Interventions: Drug: Esomeprazole
Drug: Omeprazole

First Posted Date: 2008-03-12

Last Posted Date: 2010-06-17

Lead Sponsor: AstraZeneca

Target Recruit Count: 540

Registration Number: NCT00634114

Locations: 🇯🇵
Research Site, Tottori, Japan

Does Omeprazole Decrease Intestinal Calcium Absorption?

Phase 4

Completed

Conditions: Achlorhydria
Osteoporosis
Hip Fracture
GERD

Interventions: Drug: Omeprazole

First Posted Date: 2007-12-28

Last Posted Date: 2013-02-15

Lead Sponsor: University of Wisconsin, Madison

Target Recruit Count: 23

Registration Number: NCT00582972

Locations: 🇺🇸
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States

Safety and Efficacy Study of Viokase® 16 for the Correction of Steatorrhea

Phase 3

Completed

Conditions: Pancreatectomy
Exocrine Pancreatic Insufficiency
Chronic Pancreatitis

Interventions: Drug: Viokase® 16
Drug: Placebo
Drug: Proton pump inhibitor (PPI)
Drug: Omeprazole

First Posted Date: 2007-11-16

Last Posted Date: 2017-03-16

Lead Sponsor: Forest Laboratories

Target Recruit Count: 50

Registration Number: NCT00559364

Locations: 🇵🇱
III Oddzial Chorób Wewnetrznych i Gastroenterologii, Bialystok, Poland
🇵🇱
Uniwersytecki Szpital Kliniczny nr 1 im, Lodz, Poland
🇵🇱
SP Szpital Kliniczny nr 4 w Lublinie, Lublin, Poland

and more 15 locations

Ulcer Prevention Study in Post Gastric Bypass Patients

Phase 4

Completed

Conditions: Marginal Ulcers

Interventions: Drug: Omeprazole
Drug: Famotidine

First Posted Date: 2007-11-14

Last Posted Date: 2017-01-19

Lead Sponsor: University of Missouri-Columbia

Target Recruit Count: 40

Registration Number: NCT00557349

Locations: 🇺🇸
University of Missouri Health Care, Columbia, Missouri, United States

Drug Development Updates

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