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Generated: December 10, 2018

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CLINICAL TRIALS PROFILE FOR PRILOSEC OTC

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Clinical Trials for Prilosec Otc

Trial ID Title Status Sponsor Phase Summary
NCT00001191 The Use of Oral Omeprazole and Intravenous Pantoprazole in Patients With Hypersecretion of Gastric Acid Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 2 Patients with Zollinger-Ellison Syndrome suffer from ulcers of the upper gastrointestinal tract, higher than normal levels of gastric acid, and tumors of the pancreas known as non-beta islet cell tumors. Patients with Zollinger-Ellison Syndrome require continuous control of their gastric acid secretion. If gastric acid levels are permitted to rise higher than normal, patients may develop severe ulcers and other complications. This study will attempt to determine the effectiveness of Omeprazole (Prilosec) in the treatment of patients with Zollinger-Ellison Syndrome. Omeprazole is a drug that functions to decrease the amount of gastric acid secreted. Patients for this study will be selected based on a previous diagnosis of Zollinger-Ellison Syndrome and/or idiopathic (unknown cause) high levels of gastric acid secretion. The patients will undergo an evaluation including history and physical examination as well as necessary laboratory tests. The proper dose of Omeprazole will then be determined in each patient . The proper dose of Omeprazole is considered the minimum amount of omeprazole required to lower gastric acid to a safe level. Every year patients participating in this study will undergo a physical examination and history. They will be questioned about symptoms associated with Zollinger-Ellison Syndrome. Gastric acid levels will be taken and evaluated and patients will undergo an upper gastrointestinal endoscopy. The effectiveness of the treatment will be measured by a clinical history to determine the control of symptoms due to high levels of gastric acid secretion.
NCT00233935 Defined Green Tea Catechin Extract in Preventing Esophageal Cancer in Patients With Barrett's Esophagus Completed National Cancer Institute (NCI) Phase 1 The goal of this clinical research study is to test the safety of defined green tea catechin extract at different dose levels. Researchers also want to find out what effects, good and bad, it may have on individual and their risk for esophagus cancer. Esophagus cancer is an increased risk associated with Barrett's esophagus. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of defined green tea catechin extract may prevent esophageal cancer.
NCT00446004 Effect of a Proton Pump Inhibitor on Gleevec® in Healthy Volunteers Completed Novartis Phase 1 This is a research study that will investigate the effects of proton pump inhibitors (often used to treat stomach upset) on Gleevec® (a drug that is FDA-approved to treat some types of cancer) in healthy volunteers. Twelve healthy volunteers (six men and six women) will be recruited to complete the study. This research study will compare Gleevec® in the body when taken with and without proton pump inhibitors (PPI). Each volunteer will receive a 400 mg pill of Gleevec® on two occasions. On one occasion they will take the dose of Gleevec® alone (without PPI). On another occasion, they will take the Gleevec® after taking 40 mg of PPI daily by mouth for six days. Several blood samples will be drawn to measure the concentrations of Gleevec® and its breakdown products in the blood, with and without the influence of PPI.
NCT00446004 Effect of a Proton Pump Inhibitor on Gleevec® in Healthy Volunteers Completed University of Pittsburgh Phase 1 This is a research study that will investigate the effects of proton pump inhibitors (often used to treat stomach upset) on Gleevec® (a drug that is FDA-approved to treat some types of cancer) in healthy volunteers. Twelve healthy volunteers (six men and six women) will be recruited to complete the study. This research study will compare Gleevec® in the body when taken with and without proton pump inhibitors (PPI). Each volunteer will receive a 400 mg pill of Gleevec® on two occasions. On one occasion they will take the dose of Gleevec® alone (without PPI). On another occasion, they will take the Gleevec® after taking 40 mg of PPI daily by mouth for six days. Several blood samples will be drawn to measure the concentrations of Gleevec® and its breakdown products in the blood, with and without the influence of PPI.
NCT00674115 A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED) Completed Valeant Pharmaceuticals International, Inc. Phase 3 Open-label randomized crossover design studies. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will have repeat evaluations at Day 7. The other 30 participants will receive a single administration of sodium bicarbonate.
NCT00674115 A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED) Completed Bayer Phase 3 Open-label randomized crossover design studies. 60 participants will be evaluated on Day 1 to compare effects on stomach acid; 30 participants will continue treatment for 7 days and will have repeat evaluations at Day 7. The other 30 participants will receive a single administration of sodium bicarbonate.
NCT00746733 Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC Completed Shire Phase 1 The purpose of this study is to determine if taking Vyvanse with Prilosec OTC or Adderall XR with Prilosec OTC changes how quickly the drug is absorbed into the body and/or changes how much of the drug is absorbed into the body.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Prilosec Otc

Condition Name

Condition Name for Prilosec Otc
Intervention Trials
Healthy 7
Healthy Volunteers 2
Gastric Acid 2
Human Experimentation 2
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Condition MeSH

Condition MeSH for Prilosec Otc
Intervention Trials
Gastroesophageal Reflux 2
Zollinger-Ellison Syndrome 1
Hepatitis C 1
Gastrinoma 1
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Clinical Trial Locations for Prilosec Otc

Trials by Country

Trials by Country for Prilosec Otc
Location Trials
United States 14
India 2
Netherlands 1
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Trials by US State

Trials by US State for Prilosec Otc
Location Trials
Maryland 3
Oklahoma 2
Pennsylvania 2
Texas 2
Kansas 1
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Clinical Trial Progress for Prilosec Otc

Clinical Trial Phase

Clinical Trial Phase for Prilosec Otc
Clinical Trial Phase Trials
Phase 4 2
Phase 3 4
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Prilosec Otc
Clinical Trial Phase Trials
Completed 20
Active, not recruiting 1
Unknown status 1
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Clinical Trial Sponsors for Prilosec Otc

Sponsor Name

Sponsor Name for Prilosec Otc
Sponsor Trials
Dr. Reddy's Laboratories Limited 4
Bayer 4
Procter and Gamble 2
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Sponsor Type

Sponsor Type for Prilosec Otc
Sponsor Trials
Industry 21
Other 4
NIH 2
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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Medtronic
US Army
Julphar
Deloitte
Mallinckrodt
Johnson and Johnson
Baxter
Chubb

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