CLINICAL TRIALS PROFILE FOR PRILOSEC OTC

505(b)(2) Clinical Trials for Prilosec Otc

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	2008-09-08	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	Completed	The University of Texas Health Science Center at San Antonio	Early Phase 1	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.

All Clinical Trials for Prilosec Otc

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	1983-02-03	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.
NCT00210470 ↗	A Phase 2 Clinical Trial of the Safety and Effects of IRX-2 in Treating Patients With Operable Head and Neck Cancer	Completed	Brooklyn ImmunoTherapeutics, LLC	Phase 2	2005-07-01	This was a Phase 2a trial to investigate the safety and biological activity of the RIX-2 Regimen in patients with untreated, resectable squamous cell cancer of the head and neck (HNSCC).
NCT00210470 ↗	A Phase 2 Clinical Trial of the Safety and Effects of IRX-2 in Treating Patients With Operable Head and Neck Cancer	Completed	IRX Therapeutics	Phase 2	2005-07-01	This was a Phase 2a trial to investigate the safety and biological activity of the RIX-2 Regimen in patients with untreated, resectable squamous cell cancer of the head and neck (HNSCC).
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.

Clinical Trial Conditions for Prilosec Otc

Condition Name

Condition Name for Prilosec Otc
Intervention	Trials
Healthy	12
Healthy Volunteers	4
Chronic Low Back Pain	2
Gastric Acid	2

Condition MeSH

Condition MeSH for Prilosec Otc
Intervention	Trials
Gastroesophageal Reflux	7
Esophagitis	4
Ulcer	3
Malnutrition	2

Clinical Trial Locations for Prilosec Otc

Trials by Country

Trials by Country for Prilosec Otc
Location	Trials
United States	83
Japan	36
India	7
Canada	5
Brazil	4

Trials by US State

Trials by US State for Prilosec Otc
Location	Trials
Pennsylvania	7
Arizona	7
California	6
Texas	5
New York	5

Clinical Trial Progress for Prilosec Otc

Clinical Trial Phase

Clinical Trial Phase for Prilosec Otc
Clinical Trial Phase	Trials
Phase 4	12
Phase 3	7
Phase 2	3

Clinical Trial Status

Clinical Trial Status for Prilosec Otc
Clinical Trial Phase	Trials
Completed	42
Withdrawn	3
Unknown status	2

Clinical Trial Sponsors for Prilosec Otc

Sponsor Name

Sponsor Name for Prilosec Otc
Sponsor	Trials
Bayer	4
Dr. Reddy's Laboratories Limited	4
Brooklyn ImmunoTherapeutics, LLC	3

Sponsor Type

Sponsor Type for Prilosec Otc
Sponsor	Trials
Industry	44
Other	23
NIH	10

Prilosec OTC: Clinical Trials, Market Analysis, and Projections

Introduction to Prilosec OTC

Prilosec OTC, containing the active ingredient omeprazole, is a widely used over-the-counter (OTC) medication for the treatment of frequent heartburn. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Primary Efficacy End Points

Clinical trials for Prilosec OTC have been extensive, involving over 18,000 participants in 15 new OTC clinical trials. The primary efficacy end point was "no heartburn over the previous 24 hours," indicating complete heartburn relief for a full day. These trials evaluated efficacy following the first dose, on the last dose, and over 14 days of dosing during the double-blind phase[1].

Secondary Efficacy End Points

In addition to the primary end point, secondary efficacy end points included "complete prevention of nocturnal heartburn" and "occurrence of no more than mild heartburn." These studies demonstrated the effectiveness of Prilosec OTC in managing heartburn symptoms across various scenarios[1].

Pharmacokinetics

A study involving 29 healthy subjects showed that the bioavailability of Prilosec OTC tablets is similar to that of the prescription Prilosec capsules. This study was a randomized, open-label, crossover design with a five-day washout period between treatments, confirming the bioequivalence of the OTC formulation[1].

Compliance and Consumer Behavior

Label-comprehension studies and an actual-use trial were conducted to evaluate consumer behavior and compliance with label directions. These studies found that consumers were highly adherent to label dosing instructions, with over 91% of subjects using the product as specified. The results strongly support the appropriate use of Prilosec OTC by consumers with frequent heartburn[1].

Market Analysis

Current Market Size

As of 2024, the omeprazole market size was valued at USD 1.13 billion. This market is projected to grow significantly, reaching USD 2.56 billion by 2037, with a compound annual growth rate (CAGR) of over 6.5% during the forecast period[2].

Growth Drivers

Several factors are driving the growth of the omeprazole market:

• Increasing Chronic Diseases: The global rise in chronic diseases such as cancer, diabetes, and respiratory ailments is expected to boost market growth. By 2050, these diseases are projected to account for 90% of all global fatalities, according to the World Health Organization (WHO)[2].
• H. pylori Elimination Therapy: Positive results from clinical trials using omeprazole in H. pylori elimination therapy, such as the Talicia capsule by RedHill Biopharma, are anticipated to increase demand[2].
• Shift to OTC: The increasing shift from prescription to OTC medications is another significant driver. Prilosec OTC, being the first OTC treatment for frequent heartburn approved by the FDA, has capitalized on this trend[4].

Market Segmentation

The omeprazole market is segmented by dosage form, with capsules expected to dominate the market. By 2037, the capsule segment is projected to occupy 52% of the market share. Tablets, however, remain popular due to their ease of handling and cost-effectiveness[2].

Regional Analysis

North America is set to dominate the market, accounting for 59% of the revenue share by 2037. The prevalence of H. pylori infection and peptic ulcers in the US, affecting around 4.5 million individuals annually, contributes significantly to this regional growth[2].

Projections and Future Outlook

Market Growth

The proton pump inhibitors (PPIs) market, which includes omeprazole, is expected to reach USD 17.16 billion by 2030, growing at a CAGR of 5.14% from 2024 to 2030. This growth is driven by the increasing prevalence of gastroesophageal reflux disease (GERD) and other gastrointestinal disorders[5].

Challenges and Opportunities

Despite the positive growth projections, the market faces challenges such as the increasing use of generic products and concerns about side effects associated with long-term PPI use. For instance, studies have suggested a marginal increase in the risk of COVID-19 infection and poor outcomes in patients taking PPIs, although this impact is expected to diminish as the pandemic subsides[5].

Innovations and New Product Launches

To leverage market opportunities, companies are developing novel products. For example, Xiromed LLC launched Omeprazole Delayed-Release Capsules, 20mg, a generic version of Prilosec, in March 2021. Such launches are expected to propel market growth[5].

Regulatory and Patient Access Initiatives

AstraZeneca, the manufacturer of Prilosec, has been involved in efforts to enhance patient access and ensure appropriate usage guidelines. Collaborations with healthcare providers to raise awareness about the benefits and potential side effects of long-term PPI use are ongoing, supporting the continued growth of the market[3].

Key Takeaways

• Clinical Efficacy: Prilosec OTC has demonstrated strong efficacy in clinical trials, providing complete heartburn relief for a significant number of participants.
• Market Growth: The omeprazole market is projected to grow significantly, driven by increasing chronic diseases, H. pylori elimination therapy, and the shift to OTC medications.
• Regional Dominance: North America is expected to dominate the market due to the high prevalence of gastrointestinal disorders.
• Challenges and Opportunities: The market faces challenges from generic products and side effect concerns but is driven by innovations and new product launches.
• Regulatory Initiatives: Efforts to enhance patient access and awareness about PPI use are crucial for market growth.

FAQs

Q: What is the primary efficacy end point in Prilosec OTC clinical trials?

A: The primary efficacy end point is "no heartburn over the previous 24 hours," indicating complete heartburn relief for a full day[1].

Q: How does the bioavailability of Prilosec OTC tablets compare to prescription Prilosec capsules?

A: The bioavailability of Prilosec OTC tablets is similar to that of the commercially available 20 mg prescription Prilosec capsules[1].

Q: What is the projected market size of the omeprazole market by 2037?

A: The omeprazole market is projected to reach USD 2.56 billion by 2037, growing at a CAGR of over 6.5% during the forecast period[2].

Q: Which region is expected to dominate the omeprazole market?

A: North America is expected to dominate the market, accounting for 59% of the revenue share by 2037[2].

Q: What are some of the challenges facing the proton pump inhibitors market?

A: Challenges include the increasing use of generic products and concerns about side effects associated with long-term PPI use, such as an increased risk of COVID-19 infection[5].

Sources

1. Prilosec OTC Product Monograph. Prilosecotc.com.
2. Omeprazole Market Size & Share | Growth Forecasts 2037. Researchnester.com.
3. Gastroesophageal Reflux Disease Market Estimated to Reach a CAGR of 1.21% during 2024-2034. Biospace.com.
4. Prilosec OTC (omeprazole) Information - FDA. FDA.gov.
5. Proton Pump Inhibitors Market - PPIS - Size, Share & Analysis. Mordorintelligence.com.