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Last Updated: January 28, 2020

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CLINICAL TRIALS PROFILE FOR PRILOSEC

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505(b)(2) Clinical Trials for Prilosec

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT00746733 Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC Completed Shire Phase 1 2008-09-01 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.
OTC NCT01077076 Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole (P07812) (COMPLETED) Completed Bayer Phase 3 2008-12-01 This randomized, crossover study is to evaluate the early effectiveness, defined as effect on intragastric pH during the first 4 hours after dosing, of Zegerid, Prilosec over-the-counter (OTC) Tablets, and placebo on the 4th day of treatment to inhibit acid secretion. Additional purposes are to: 1. provide pharmacodynamic evidence comparing 24-hr inhibition of acid secretion on the 1st, 4th, and 11th days of dosing with each of the indicated treatments; 2. compare Zegerid and Prilosec OTC for achieving their steady-state effects for controlling 24-hr gastric acidity at steady-state on the 4th and 11th day of dosing. 3. evaluate early effectiveness, defined as effect on intragastric pH during the first 4 hours after administration, of Zegerid, Prilosec OTC Tablets, and placebo on acid inhibition at steady-state when administered on the 11th day of dosing.
OTC NCT01122160 Gastric pH and Anthocyanin Absorption Completed USDA Beltsville Human Nutrition Research Center N/A 2010-05-01 Anthocyanins are phytonutrients that provide blue, purple and red colors to fruits and vegetables. The purpose of the study is to determine whether absorption of anthocyanins occurs in the acid pH of the stomach and to determine whether altering stomach pH by use of an over-the-counter medicine, Prilosec TM, alters absorption of anthocyanins from strawberries and blackberries.
OTC NCT02844621 Effect of Proton Pump Inhibitors on Gut Microbiota and Systemic Inflammation in Older Adults Active, not recruiting The University of Texas Health Science Center at San Antonio Phase 0 2016-05-01 The purpose of this study is to evaluate the effects of a common over-the-counter medication, omeprazole, on the normal gut bacteria and inflammation in the body in healthy older adults.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Prilosec

Trial ID Title Status Sponsor Phase Start Date 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 1983-02-01 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 2005-11-01 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 2007-04-01 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 2007-04-01 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 2008-04-01 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 2008-04-01 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 2008-09-01 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 >Phase >Start Date >Summary

Clinical Trial Conditions for Prilosec

Condition Name

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

Condition MeSH for Prilosec
Intervention Trials
Gastroesophageal Reflux 2
Hepatitis, Chronic 1
Barrett Esophagus 1
Hepatitis C, Chronic 1
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Clinical Trial Locations for Prilosec

Trials by Country

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

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

Clinical Trial Phase

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

Sponsor Name

Sponsor Name for Prilosec
Sponsor Trials
Dr. Reddy's Laboratories Limited 4
Bayer 4
University of Pittsburgh 2
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Sponsor Type

Sponsor Type for Prilosec
Sponsor Trials
Industry 21
Other 4
NIH 2
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