CLINICAL TRIALS PROFILE FOR OMEPRAZOLE

505(b)(2) Clinical Trials for Omeprazole

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	NCT01000220 ↗	Evaluation of Omeprazole Effect on Glaucoma	Unknown status	Ophthalmic Research Center	Phase 1	1969-12-31	Omeprazole is a safe drug listed in OTC drug due to its safety. It acts by irreversible inhibition of K/H ATP ase pump and also Na/K ATP ase, Na/H ATP ase.Considering these actions the effect of omeprazole on decreasing intra ocular pressure is an issue of debate.In this Randomized Clinical Trial conducted in labafinejad hospital, patients with glaucoma who need to take omeprazole due to GI problem are evaluated in two groups including placebo and drug users. The effect will be finally assessed.
OTC	NCT01000220 ↗	Evaluation of Omeprazole Effect on Glaucoma	Unknown status	Shahid Beheshti University of Medical Sciences	Phase 1	1969-12-31	Omeprazole is a safe drug listed in OTC drug due to its safety. It acts by irreversible inhibition of K/H ATP ase pump and also Na/K ATP ase, Na/H ATP ase.Considering these actions the effect of omeprazole on decreasing intra ocular pressure is an issue of debate.In this Randomized Clinical Trial conducted in labafinejad hospital, patients with glaucoma who need to take omeprazole due to GI problem are evaluated in two groups including placebo and drug users. The effect will be finally assessed.
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.

All Clinical Trials for Omeprazole

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.
NCT00002682 ↗	Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach	Completed	National Cancer Institute (NCI)	Phase 2	1995-08-10	RATIONALE: Antibiotic therapy and antacids are used to treat Helicobacter pylori infection of the stomach. These treatments may also have an effect on gastric MALT lymphoma of the stomach. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy with amoxicillin, clarithromycin, tetracycline, and metronidazole plus antacids in patients with MALT lymphoma of the stomach.
NCT00002682 ↗	Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach	Completed	M.D. Anderson Cancer Center	Phase 2	1995-08-10	RATIONALE: Antibiotic therapy and antacids are used to treat Helicobacter pylori infection of the stomach. These treatments may also have an effect on gastric MALT lymphoma of the stomach. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy with amoxicillin, clarithromycin, tetracycline, and metronidazole plus antacids in patients with MALT lymphoma of the stomach.
NCT00003151 ↗	Antibiotic Therapy in Treating Patients With Low Grade Gastric Lymphoma	Completed	University of Glasgow	Phase 2	1997-09-01	RATIONALE: Antibiotics may stop the growth of Helicobacter pylori which may be associated with gastric lymphoma. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy in treating patients with low grade gastric lymphoma that has not been previously treated.

Clinical Trial Conditions for Omeprazole

Condition Name

Condition Name for Omeprazole
Intervention	Trials
Healthy	67
Healthy Volunteers	26
Helicobacter Pylori Infection	21
Gastroesophageal Reflux Disease	11

Condition MeSH

Condition MeSH for Omeprazole
Intervention	Trials
Gastroesophageal Reflux	48
Ulcer	22
Hemorrhage	21
Helicobacter Infections	20

Clinical Trial Locations for Omeprazole

Trials by Country

Trials by Country for Omeprazole
Location	Trials
United States	359
Japan	41
United Kingdom	40
China	37
Canada	32

Trials by US State

Trials by US State for Omeprazole
Location	Trials
Texas	33
California	23
Arizona	22
Florida	22
Michigan	16

Clinical Trial Progress for Omeprazole

Clinical Trial Phase

Clinical Trial Phase for Omeprazole
Clinical Trial Phase	Trials
Phase 4	85
Phase 3	60
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for Omeprazole
Clinical Trial Phase	Trials
Completed	309
Unknown status	36
Recruiting	29

Clinical Trial Sponsors for Omeprazole

Sponsor Name

Sponsor Name for Omeprazole
Sponsor	Trials
AstraZeneca	18
Bristol-Myers Squibb	15
Boehringer Ingelheim	13

Sponsor Type

Sponsor Type for Omeprazole
Sponsor	Trials
Industry	319
Other	302
NIH	18

Omeprazole: Clinical Trials, Market Analysis, and Projections

Introduction

Omeprazole, a widely used proton pump inhibitor (PPI), has been a cornerstone in the treatment of various gastrointestinal disorders, including gastroesophageal reflux disease (GERD), duodenal ulcers, and gastric ulcers. This article delves into the recent clinical trials, market analysis, and future projections for omeprazole.

Clinical Trials and Diagnostic Accuracy

The Omeprazole Test for GERD

A significant clinical trial evaluated the diagnostic accuracy of the omeprazole test in detecting GERD. This randomized, double-blind, placebo-controlled, crossover trial involved 43 patients with symptoms suggestive of GERD. Patients were randomly assigned to receive either omeprazole or a placebo for 7 days, followed by the alternative treatment for another 7 days. The study found that the omeprazole test had a high sensitivity and specificity in diagnosing GERD, with symptom improvement serving as a reliable indicator[1].

Comparison with Other Therapies

Another study compared the efficacy of omeprazole with antireflux surgery in controlling GERD over a 5-year follow-up period. The trial involved 310 patients with erosive esophagitis and found that antireflux surgery was more effective in controlling symptoms and preventing treatment failure compared to continuous omeprazole therapy. However, adjusting the omeprazole dose in case of symptom recurrence narrowed the efficacy gap between the two treatments[4].

Market Analysis

Current Market Size and Growth

The omeprazole market was valued at USD 1.13 billion in 2024 and is projected to exceed USD 2.56 billion by 2037, growing at a compound annual growth rate (CAGR) of over 6.5% during the forecast period of 2025-2037. This growth is driven by increasing cases of chronic diseases globally, such as cancer, diabetes, and respiratory ailments, which are expected to account for 90% of all global fatalities by 2050[3].

Global Demand and Supply Dynamics

The global market for omeprazole is experiencing a surge in prices due to sustained demand from the healthcare and pharmaceutical industries, combined with limited supply. Factors such as the contraction in manufacturing in China, severe weather events, and increased demand for raw materials like pyridine have contributed to these price increases. Additionally, anticipated rises in cargo rates and potential labor disputes are expected to further exacerbate supply chain disruptions and drive up prices[2].

Regional Market Trends

The Asia Pacific region is expected to witness significant growth in the omeprazole market, contrasting with the historic growth seen in North America. This shift is driven by rising investments in novel drugs for treating gastrointestinal diseases and the increasing prevalence of GERD in the region[5].

Market Segmentation

Dosage Forms

The omeprazole market is segmented by dosage forms, with capsules expected to dominate the market, occupying around 52% of the market share by 2037. Tablets, while easy to handle and inexpensive, also contribute significantly to the market[3].

Indications

Omeprazole is used to treat a variety of gastrointestinal conditions, including duodenal ulcers, gastric ulcers, gastroesophageal reflux disease (GERD), and erosive esophagitis. The increasing incidence of these conditions globally is a key driver of market growth[3].

Projections and Future Outlook

Market Size Projections

The global proton pump inhibitors (PPIs) market, which includes omeprazole, is anticipated to grow from USD 3.34 billion in 2024 to USD 5.19 billion by 2034, at a CAGR of 4.50% during the forecast period of 2025-2034. This growth is driven by the rising prevalence of GERD and other gastrointestinal diseases, as well as investments in novel drug developments[5].

Challenges and Opportunities

Despite the positive growth projections, the omeprazole market faces challenges such as supply chain disruptions, raw material price increases, and potential labor disputes. However, opportunities lie in the development of new formulations and the expansion into emerging markets, particularly in the Asia Pacific region[2][3].

Key Takeaways

• Clinical Trials: The omeprazole test shows high diagnostic accuracy for GERD, and while antireflux surgery may be more effective in long-term symptom control, omeprazole remains a viable treatment option.
• Market Growth: The omeprazole market is expected to grow significantly, driven by increasing cases of chronic gastrointestinal diseases and rising demand.
• Supply Chain: Global supply chain disruptions and raw material price increases are likely to impact omeprazole prices in the near future.
• Regional Trends: The Asia Pacific region is poised to become a significant market for omeprazole due to rising investments in healthcare and increasing disease prevalence.

FAQs

Q: What is the omeprazole test, and how accurate is it for diagnosing GERD?

A: The omeprazole test involves administering a high-dose proton pump inhibitor to patients with symptoms suggestive of GERD. It has been shown to have high sensitivity and specificity in diagnosing GERD, with symptom improvement serving as a reliable indicator[1].

Q: How does omeprazole compare to antireflux surgery in treating GERD?

A: Antireflux surgery is more effective in controlling GERD symptoms over a long period compared to continuous omeprazole therapy. However, adjusting the omeprazole dose can narrow the efficacy gap between the two treatments[4].

Q: What are the key drivers of the omeprazole market growth?

A: The key drivers include increasing cases of chronic gastrointestinal diseases, rising demand from the healthcare and pharmaceutical industries, and investments in novel drug developments[3][5].

Q: Why are omeprazole prices surging globally?

A: Omeprazole prices are surging due to sustained market demand, limited supply, increased raw material costs, and supply chain disruptions, particularly in China[2].

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

A: The omeprazole market is projected to exceed USD 2.56 billion by 2037, growing at a CAGR of over 6.5% during the forecast period of 2025-2037[3].

Sources

1. Clinical and Economic Assessment of the Omeprazole Test in Detecting Gastroesophageal Reflux Disease - JAMA Internal Medicine
2. Omeprazole Prices Surge: Global Market Grapples with Supply Squeeze and Shipping Hurdles - ChemAnalyst
3. Omeprazole Market Size & Share | Growth Forecasts 2037 - Research Nester
4. Continued (5-year) followup of a randomized clinical trial comparing antireflux surgery and omeprazole in gastroesophageal reflux disease - PubMed
5. Proton Pump Inhibitors (PPIs) Market Size, Share, Analysis 2025-2034 - Expert Market Research