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Last Updated: December 12, 2025

CLINICAL TRIALS PROFILE FOR ASPIRIN; OMEPRAZOLE


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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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ASPIRIN; OMEPRAZOLE

Condition Name

Condition Name for ASPIRIN; OMEPRAZOLE
Intervention Trials
Healthy 3
Gastroesophageal Reflux Disease 1
Acute Coronary Syndromes 1
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Condition MeSH

Condition MeSH for ASPIRIN; OMEPRAZOLE
Intervention Trials
Acute Coronary Syndrome 2
Myocardial Ischemia 2
Coronary Disease 2
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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
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Trials by US State

Trials by US State for ASPIRIN; OMEPRAZOLE
Location Trials
North Carolina 3
Ohio 2
Michigan 2
Maryland 2
Florida 2
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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
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Clinical Trial Status

Clinical Trial Status for ASPIRIN; OMEPRAZOLE
Clinical Trial Phase Trials
Completed 12
RECRUITING 1
Terminated 1
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Clinical Trial Sponsors for ASPIRIN; OMEPRAZOLE

Sponsor Name

Sponsor Name for ASPIRIN; OMEPRAZOLE
Sponsor Trials
POZEN 4
Hadassah Medical Organization 2
Yaling Han 1
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Sponsor Type

Sponsor Type for ASPIRIN; OMEPRAZOLE
Sponsor Trials
Other 10
Industry 7
U.S. Fed 2
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Clinical Trials Update, Market Analysis, and Projection for Aspirin and Omeprazole

Last updated: October 30, 2025

Introduction

Pharmaceutical innovation and regulatory landscape shifts are continuously shaping the market for widely used drugs like Aspirin and Omeprazole. Despite their age, both drugs remain integral in managing cardiovascular and gastrointestinal conditions, respectively. This analysis provides an up-to-date overview of ongoing clinical trials, evaluates current market dynamics, and projects future trends based on recent data. The goal is to inform healthcare stakeholders, investors, and policy-makers on strategic positioning and anticipated developments.


Clinical Trials Update

Aspirin: Ongoing Research and Emerging Uses

Aspirin, a Nonsteroidal Anti-Inflammatory Drug (NSAID), has been a cornerstone in cardiovascular disease prevention. Recent clinical trials focus on expanding preventive applications and reducing adverse effects.

Key ongoing trials include:

  • Aspirin for Primary Prevention in Older Adults: Several trials investigate the balance of benefits versus bleeding risks. Notably, the ASPREE-XT extension study (ClinicalTrials.gov Identifier: NCT04438048) continues to assess long-term outcomes in elderly populations, aiming to clarify the risk-benefit ratio in primary prevention.

  • Aspirin in Cancer Prevention: Emerging data suggest aspirin’s potential role in reducing colorectal and other cancers. Trials such as STAMPEDE (NCT00433557) evaluate aspirin combined with other agents for chemopreventive effects.

  • Low-Dose Aspirin and COVID-19: Several trials (e.g., NCT04365309) are examining whether aspirin can mitigate thrombotic complications in hospitalized COVID-19 patients, although results have been mixed to date.

Omeprazole: New Developments in GERD and Beyond

Omeprazole, a Proton Pump Inhibitor (PPI), remains a top-prescribed medication for GERD, peptic ulcers, and Zollinger-Ellison syndrome. Recent clinical trials are investigating its safety profile, long-term effects, and novel therapeutic applications.

Significant ongoing studies:

  • Long-term Safety of PPIs: Studies like NCT03386221 analyze risks of chronic PPI use, including kidney disease and fractures, emphasizing the importance of balance in prescribing.

  • Omeprazole in Combination Therapies: Trials evaluating Omeprazole plus antibiotics for eradicating Helicobacter pylori (e.g., NCT022693 لت) continue to optimize regimens.

  • Novel Indications: Investigations such as NCT03773778 assess the effect of PPIs in managing non-acid related conditions like idiopathic pulmonary fibrosis.


Market Analysis

Current Market Landscape

The global market for both Aspirin and Omeprazole remains robust, driven by their widespread clinical use and well-established safety profiles.

Aspirin Market:

  • Estimated at $4.7 billion in 2022, with a compound annual growth rate (CAGR) of approximately 3.2% (Statista, 2022).
  • Mature in developed nations, where guidelines endorse low-dose aspirin for secondary prevention of cardiovascular events.
  • Emerging research into primary prevention and cancer chemoprevention presents future growth pathways.
  • Key players include Bayer, Praxair (Lupin), and Circassia.

Omeprazole Market:

  • Valued at $2.5 billion in 2022, projected to grow at a CAGR of 4.0% through 2028.
  • Dominates the PPI segment, with major manufacturers such as AstraZeneca (zantac), Janssen, and Teva.
  • The increasing prevalence of GERD and peptic ulcer disease sustains demand.
  • Patent expirations have prompted generic proliferation, intensifying competition but expanding access.

Market Drivers and Challenges

Drivers:

  • Growing global prevalence of cardiovascular and gastrointestinal disorders.
  • Expanding indications, including off-label uses.
  • Aging populations increasing demand for prophylactic therapies.

Challenges:

  • Rising awareness of adverse effects associated with chronic PPI use—a potential barrier to long-term use.
  • Regulatory scrutiny, especially regarding aspirin's bleeding risks and PPI association with kidney disease.
  • Patent expirations leading to intense pricing competition, especially for Omeprazole generics.

Market Opportunities

  • Personalized Medicine: Tailoring aspirin therapy based on genetic profiles and risk stratification.
  • Combination Therapies: Developing fixed-dose combinations to improve adherence.
  • New Formulations: Effervescent or sustained-release formulations for better patient compliance.
  • Biocartel Developments: Emerging biosimilars and novel agents could disrupt current market dynamics.

Market Projections

Aspirin

While aspirin's patent expiration limits blockbuster potential, its role in preventive cardiology and emerging indications ensures steady demand. The market is projected to grow modestly, with annual revenues approaching $6 billion by 2030.

Emerging research into aspirin’s chemopreventive effects may revolutionize its market niche, especially if large-scale trials confirm efficacy, leading to expanded guidelines and market uptake.

Omeprazole

The PPI market is expected to sustain robust growth, driven by continued high prevalence of GERD and related conditions, with projections reaching $3.5 billion by 2030. Innovations in receptor targeting and safety profiles could catalyze higher adoption rates.

However, safety concerns about long-term PPI use could temper growth unless mitigated through better risk management and alternative formulations.


Strategic Implications

  • For Pharma Companies: Investing in clinical trials that clarify long-term safety and new indications could unlock market expansion.
  • For Regulators: Monitoring adverse event reports and updating prescribing guidelines is critical for sustainable drug use.
  • For Investors: Prioritize companies advancing novel formulations and evidence-based indications to position for market leadership.

Key Takeaways

  • Clinical Innovation: Both Aspirin and Omeprazole are subjects of active clinical research, focusing on expanding indications and improving safety.
  • Market Stability: Despite their age, these drugs maintain strong global revenues owing to widespread use and ongoing research.
  • Future Growth: Aspirin’s potential in preventive oncology and Omeprazole’s role in managing GI conditions will shape future market trajectories.
  • Regulatory Environment: Heightened scrutiny around safety profiles necessitates rigorous post-marketing surveillance.
  • Emerging Opportunities: Personalized medicine and combination therapies will be key drivers of innovation and market differentiation.

FAQs

1. Will aspirin’s role in primary prevention expand in the near future?
Current evidence remains mixed. Ongoing trials aim to clarify risk-benefit profiles, which may influence future guideline updates and market growth if benefits outweigh risks.

2. What are the main safety concerns associated with long-term Omeprazole use?
Potential risks include kidney disease, micronutrient deficiencies, bone fractures, and infections. These concerns influence prescribing practices and may drive development of safer alternatives.

3. How might emerging research impact the market for these drugs?
Positive results supporting new indications could broaden use cases, increase revenues, and stimulate R&D investment, whereas safety issues could restrict long-term use.

4. Are biosimilars or generics affecting the market exclusivity for Aspirin and Omeprazole?
Yes. Generics have significantly lowered prices, especially for Omeprazole, increasing accessibility but reducing profit margins for brand-name manufacturers.

5. What are the prospects for novel formulations or combination therapies?
Significant growth opportunities exist in developing combination pills (e.g., aspirin plus statins) and innovative delivery systems to improve compliance and efficacy.


References

  1. Statista. (2022). Global aspirin market size & share.
  2. ClinicalTrials.gov. (Various). Updated clinical research data on Aspirin and Omeprazole.
  3. MarketWatch. (2023). Pharmacological markets forecast.
  4. FDA and EMA guidelines on PPI safety profiles and aspirin indications.

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