CLINICAL TRIALS PROFILE FOR ASPIRIN; OMEPRAZOLE

All Clinical Trials for ASPIRIN; OMEPRAZOLE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00349661 ↗	Influence Of Omeprazole On The Anti-Platelet Action Of Clopidogrel	Completed	University Hospital, Brest	Phase 3	2006-06-01	Objectives: A prospective investigation of the effect of omeprazole, a proton pump inhibitor, on the anti-platelet action of clopidogrel. The main decision criterion will concern change in VASP protein phosphorylation under treatment. Phosphorylation will be measured before and after administration of omeprazole versus placebo in patients undergoing clopidogrel treatment. Type of study: Single center, double blind, randomized parallel group study versus placebo, comparing two treatment groups: - clopidogrel + omeprazole + standard regime (beta-blockers, atorvastatin, IEC, aspirin) - clopidogrel + placebo+ standard regime (beta-blockers, atorvastatin, IEC, aspirin) Study population: 120 patients from the Cardiology Department of Brest University hospital, Brest (France), receiving a standard treatment comprising a loading dose of clopidogrel followed by a daily dose of 75 mg associated to 75 mg aspirin, will be randomized between 20 mg/day omeprazole and 20 mg/day placebo treatment groups. The efficacy of clopidogrel will be assessed by inter-group comparison on the VASP test. Study period: 7 days' treatment per patient. Total study period estimated at 6 months. Expected findings: The results should confirm the suspected negative effect of omeprazole on clopidogrel's impact on arterial thrombosis risk, secondarily allowing new recommendations to be drawn up for this association.
NCT00441519 ↗	A Parallel Group Study to Compare the Gastroprotective Effects of PA 325 Versus 81 mg Enteric Coated Aspirin	Completed	POZEN	Phase 1	2007-02-01	To compare the gastroprotective effects of a once-daily dose of PA 325 combination tablet
NCT00442052 ↗	To Compare the Gastroprotective Effects and Pharmacokinetic Profile of PA Versus Enteric-Coated Aspirin	Completed	POZEN	Phase 1	2006-11-01	Primary: To compare the gastroprotective effects of a once-daily dose of PA 325 combination tablet combining 325 mg pH sensitive aspirin and 20 mg immediate release omeprazole versus a once-daily dose of 325 mg enteric coated aspirin utilizing Lanza scores from endoscopy findings in normal healthy volunteers.
NCT00557921 ↗	Clopidogrel and the Optimization of Gastrointestinal Events (COGENT-1)	Terminated	Cogentus Pharmaceuticals	Phase 3	2007-12-01	The purpose of the COGENT-1 clinical trial is to determine whether CGT-2168 (clopidogrel and omeprazole) compared to clopidogrel is safe and effective in reducing the incidence of gastrointestinal bleeding and symptomatic ulcer disease, in the setting of concomitant aspirin therapy. Antiplatelet therapy is an essential element of care for patients with atherothrombotic disease. Bleeding is a fundamental adverse effect of all antiplatelet drugs including aspirin, clopidogrel and dual antiplatelet regimens. The gastrointestinal tract is the most common site of bleeding related to antiplatelet therapy, typically in connection with peptic ulcer disease. Recently published studies suggest the use of clopidogrel carries a gastrointestinal bleeding risk similar to that of aspirin or non-aspirin non-steroidal anti-inflammatory drugs. Patients taking any two of these drugs (clopidogrel, aspirin and/or non-aspirin NSAIDs) are exposed to an even higher risk of bleeding and ulcer disease. Cogentus Pharmaceuticals is launching phase 3 trials of a novel combination product, CGT-2168, which has the potential to significantly reduce this problem and increase patient safety. CGT-2168 combines a standard dosage of clopidogrel and a gastroprotectant (omeprazole) in a once-daily pill that may reduce the likelihood of adverse gastrointestinal events.

Clinical Trial Conditions for ASPIRIN; OMEPRAZOLE

Condition Name

Condition Name for ASPIRIN; OMEPRAZOLE
Intervention	Trials
Healthy	3
Platelet Aggregation	1
Colorectal Neoplasia	1
Proton Pump Inhiditor Treatment	1

Condition MeSH

Condition MeSH for ASPIRIN; OMEPRAZOLE
Intervention	Trials
Myocardial Ischemia	2
Coronary Disease	2
Barrett Esophagus	2
Coronary Artery Disease	2

Clinical Trial Locations for ASPIRIN; OMEPRAZOLE

Trials by Country

Trials by Country for ASPIRIN; OMEPRAZOLE
Location	Trials
United States	50
Canada	9
Australia	6
Mexico	3
France	2

Trials by US State

Trials by US State for ASPIRIN; OMEPRAZOLE
Location	Trials
North Carolina	3
Maryland	2
Florida	2
Texas	2
Ohio	2

Clinical Trial Progress for ASPIRIN; OMEPRAZOLE

Clinical Trial Phase

Clinical Trial Phase for ASPIRIN; OMEPRAZOLE
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	3
Phase 1	7

Clinical Trial Status

Clinical Trial Status for ASPIRIN; OMEPRAZOLE
Clinical Trial Phase	Trials
Completed	12
Terminated	1
Unknown status	1

Clinical Trial Sponsors for ASPIRIN; OMEPRAZOLE

Sponsor Name

Sponsor Name for ASPIRIN; OMEPRAZOLE
Sponsor	Trials
POZEN	4
Hadassah Medical Organization	2
University of Michigan Rogel Cancer Center	1

Sponsor Type

Sponsor Type for ASPIRIN; OMEPRAZOLE
Sponsor	Trials
Other	10
Industry	7
U.S. Fed	2

Clinical Trials Update, Market Analysis and Projections for Aspirin and Omeprazole

Last updated: February 21, 2026

What are the current clinical trial statuses for aspirin and omeprazole?

Aspirin

Aspirin (acetylsalicylic acid) continues active investigation in multiple clinical trials primarily targeting secondary prevention of cardiovascular events, cancer prevention, and pain management. The US National Library of Medicine registers over 35 ongoing or upcoming trials as of Q1 2023, with key focus areas including:

• Stroke and myocardial infarction prevention (Randomized controlled trials, phase 3)
• Colorectal cancer intervention (Phase 2/3, assessing chemopreventive efficacy)
• Antithrombotic therapy optimization (Phase 4, post-marketing studies evaluating new dosing regimens)

Omeprazole

Omeprazole (a proton pump inhibitor, PPI) is subject to approximately 30 clinical trials, mostly exploring:

• Long-term safety profiles in different populations (e.g., elderly, children)
• New formulations for improved bioavailability
• Therapy combinations for H. pylori eradication

Major trials include phase 3 studies assessing safety and efficacy in PPI resistance and new chronic use protocols.

How does the market for aspirin and omeprazole compare historically and currently?

Parameter	Aspirin	Omeprazole
Market size (2022)	$3.2 billion	$6.8 billion
Key applications	Cardiovascular prevention, pain, anti-inflammatory	GERD, peptic ulcers, H. pylori eradication
Leading brands	Bayer Asprin, Bufferin, Aspirin Cardio	Prilosec, Losec (OTC and prescription)

Market Trends

Aspirin’s market has been constrained by bleeding risk concerns and the availability of alternative anti-platelet agents. However, its role in secondary prevention remains supported by large-scale guidelines. Omeprazole’s market growth outpaces aspirin, driven by increasing prevalence of GERD, chronic use, and expanding indications. Patent expirations off-patent worldwide have led to significant generic proliferation.

What are the key regulatory and patent considerations?

Aspirin

• No recent patent filings; off-patent globally since 1980s.
• Regulatory focus on optimal dosing and safety, especially bleeding risks.

Omeprazole

• Patents expired in 2004 (US), leading to widespread generics.
• New formulations (e.g., delayed-release or fixed-dose combinations) continuously seek regulatory approval to extend market life.

What are the sales projections for aspirin and omeprazole over the next decade?

Aspirin

• Expected to grow modestly at 2-3% annually, reaching approximately $4.2 billion by 2032.
• Market capped by safety concerns and decreasing cardiovascular prevention indications.

Omeprazole

• Projected to reach $8.5 billion by 2032, with a CAGR of 4-5%.
• Growth driven by expanding indications, new formulations, and rising GERD prevalence.

Factors influencing projections:

1. New clinical data affirming safety of low-dose aspirin.
2. Increased adoption of generic omeprazole formulations.
3. Patent-driven innovation in PPI formulations.
4. Regulatory updates that may expand or restrict indications.

What are the key competitive landscapes for these drugs?

Aspirin

• Dominated by Bayer, Johnson & Johnson, and smaller generic manufacturers.
• Limited innovation due to patent expiry, focus on safety profile improvements.

Omeprazole

• Several generic manufacturers, with some branded players like AstraZeneca (original patent holder).
• Competition drives prices down but fosters innovation in related PPI classes and delivery methods.

What are the emerging areas of research and development?

Aspirin

• Focus on chemopreventive applications, especially in colorectal and breast cancers.
• Studies exploring low-dose regimens with minimized bleeding risk.
• Combination therapies with other anticoagulants and anticancer agents.

Omeprazole

• Developing formulations with longer duration or targeted release.
• Exploring PPI’s role in managing non-acid reflux and functional dyspepsia.
• Investigating long-term safety profiles to mitigate risks such as osteoporosis and infections.

Summary of regulatory environment

• Aspirin remains over-the-counter (OTC) in many markets; prescription-only in some indications.
• Omeprazole is available OTC and by prescription; regulatory agencies require post-marketing surveillance, especially regarding long-term safety.

Key Takeaways

• Clinical trials for aspirin focus on cancer prevention and optimized dosing; safety concerns limit broader use.
• Omeprazole market growth driven by GERD prevalence; new formulations and indications expand opportunities.
• Both drugs face increasing generic competition; innovation mainly in delivery, safety, and combination therapies.
• Aspirin's future hinges on weighing its rising evidence base against bleeding risks.
• Omeprazole’s long-term safety profile remains a central concern influencing regulatory and clinical practice.

FAQs

1. Are new formulations of aspirin in development?
Yes, research includes low-dose, coated, and combination formulations aimed at minimizing adverse effects while maintaining efficacy.

2. How are regulatory agencies addressing long-term PPI safety concerns?
Agencies like the FDA and EMA mandate post-marketing studies to monitor risks such as osteoporosis and infections, influencing prescribing guidelines.

3. What is the potential market impact of new cancer prevention trials for aspirin?
Positive results could expand aspirin’s approved indications, increasing value despite safety concerns. Negative findings may reinforce current limitations.

4. How does patent expiration influence market dynamics?
Patent expiry leads to increased generic competition, reducing prices and encouraging innovation in drug delivery and formulations.

5. What are the main factors limiting higher adoption of aspirin for primary prevention?
Safety risk profile, especially bleeding, and evolving clinical guidelines restrict use outside secondary prevention.

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References

[1] PubMed Clinical Trials Database (2023). https://clinicaltrials.gov.
[2] Grand View Research (2023). Aspirin Market Size, Share & Trends Analysis.
[3] MarketWatch (2023). Omeprazole Market Data and Industry Trends.
[4] FDA Drug Approvals and Safety Data.
[5] EMA Guidelines on PPI Post-Marketing Safety Monitoring.