CLINICAL TRIALS PROFILE FOR OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN

505(b)(2) Clinical Trials for Omeprazole And Clarithromycin And Amoxicillin

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
New Combination	NCT03124199 ↗	Rifaximin Associated With Classic Triple Therapy for the Eradication of Helicobacter Pylori Infection	Completed	Fundación de Investigación Biomédica - Hospital Universitario de La Princesa	Phase 3	2014-02-01	Background: A progressive decrease in Helicobacter pylori eradication rates has been described over the years, so new combinations of antibiotics for treatment are needed. Aim: To evaluate the efficacy and safety of the addition of rifaximin to standard triple therapy (omeprazole, amoxicillin and clarithromycin) for the eradication of H. pylori. Methods: Independent prospective pilot clinical trial (EUDRA CT: 2013-001080-23). Forty consecutive adult patients were included with H. pylori infection, dyspeptic symptoms and naive to eradication treatment. A full blood test was performed in the first 5 patients included to evaluate the safety of the treatment. H. pylori eradication was confirmed with urea breath test at least 4 weeks after the end of treatment. Treatment: Rifaximin 400 mg/8 h, clarithromycin 500 mg/12 h, amoxicillin 1 g/12 h, and omeprazole 20 mg/12 h for 10 days.

All Clinical Trials for Omeprazole And Clarithromycin And Amoxicillin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00003151 ↗	Antibiotic Therapy in Treating Patients With Low Grade Gastric Lymphoma	Completed	European Organisation for Research and Treatment of Cancer - EORTC	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.
NCT00149084 ↗	Tailored Treatment of H. Pylori Infection Based Polymorphisms of CYP2C19 and 23S rRNA of H. Pylori	Unknown status	Yokoyama Foundation for Clinical Pharmacology	Phase 3	2003-04-01	The eradication rate of the standard H. pylori eradication therapy (such as the triple therapy with a proton pump inhibitor [PPI], amoxicillin and clarithromycin) depends on bacterial susceptibility to clarithromycin and genotypes of CYP2C19 in patients. The investigators intend to investigate whether the tailored therapy based on the two above-mentioned factors increases the cure rate of the initial eradication therapy.

Clinical Trial Conditions for Omeprazole And Clarithromycin And Amoxicillin

Condition Name

Condition Name for Omeprazole And Clarithromycin And Amoxicillin
Intervention	Trials
Helicobacter Pylori Infection	15
Non-alcoholic Fatty Liver Disease	3
Helicobacter Infections	3
Gastritis	2

Condition MeSH

Condition MeSH for Omeprazole And Clarithromycin And Amoxicillin
Intervention	Trials
Helicobacter Infections	13
Communicable Diseases	7
Infections	7
Infection	6

Clinical Trial Locations for Omeprazole And Clarithromycin And Amoxicillin

Trials by Country

Trials by Country for Omeprazole And Clarithromycin And Amoxicillin
Location	Trials
United States	5
Iran, Islamic Republic of	4
Egypt	4
Spain	4
Pakistan	3

Trials by US State

Trials by US State for Omeprazole And Clarithromycin And Amoxicillin
Location	Trials
Texas	3
Missouri	1
Florida	1

Clinical Trial Progress for Omeprazole And Clarithromycin And Amoxicillin

Clinical Trial Phase

Clinical Trial Phase for Omeprazole And Clarithromycin And Amoxicillin
Clinical Trial Phase	Trials
PHASE4	1
PHASE2	3
Phase 4	14

Clinical Trial Status

Clinical Trial Status for Omeprazole And Clarithromycin And Amoxicillin
Clinical Trial Phase	Trials
Completed	23
Unknown status	8
NOT_YET_RECRUITING	3

Clinical Trial Sponsors for Omeprazole And Clarithromycin And Amoxicillin

Sponsor Name

Sponsor Name for Omeprazole And Clarithromycin And Amoxicillin
Sponsor	Trials
Tehran University of Medical Sciences	4
National Taiwan University Hospital	2
Technische Universität Dresden	1

Sponsor Type

Sponsor Type for Omeprazole And Clarithromycin And Amoxicillin
Sponsor	Trials
Other	54
Industry	6
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Omeprazole, Clarithromycin, and Amoxicillin

Last updated: October 28, 2025

Introduction

The combination therapy of Omeprazole, Clarithromycin, and Amoxicillin remains a cornerstone in the treatment of Helicobacter pylori (H. pylori) infections, a predominant cause of peptic ulcers and gastric cancer globally. This analysis provides a comprehensive review of recent clinical trial developments, current market dynamics, and future projections for these drugs, emphasizing their synergies, emerging resistance issues, and evolving treatment paradigms.

Clinical Trials Update

Recent Developments and Focus Areas

Over the past two years, clinical trials focusing on the triplet therapy of Omeprazole, Clarithromycin, and Amoxicillin have primarily targeted optimizing efficacy against resistant H. pylori strains, reducing adverse effects, and exploring novel delivery mechanisms.

• Resistance Management:
  Increasing clarithromycin resistance—a primary hurdle—has prompted trials evaluating alternative regimens. Notably, recent Phase III trials demonstrate that extending the therapy duration from 7 to 14 days improves eradication rates, especially in regions with high resistance profiles (e.g., Southeast Asia, Europe) [1].

• Alternative Proton Pump Inhibitors (PPIs):
  Research comparing Omeprazole with newer PPIs like Esomeprazole or Vonoprazan shows comparable efficacy but with improved pharmacodynamics, leading several trials to assess whether substituting Omeprazole enhances success rates [2].

• Novel Formulations:
  Encapsulated or targeted delivery mechanisms aim to improve bioavailability and compliance, with early-phase trials indicating promising results.

Resistance Trends and Impact

Clarithromycin resistance has escalated globally, with resistance rates exceeding 20–30% in many regions, undermining traditional therapy success rates [3]. Clinical trials are increasingly testing sequential therapy, quadruple therapy, or adjunctive agents to combat resistance, but the triplet remains fundamental due to widespread familiarity and existing efficacy in susceptible populations.

Regulatory Updates

Regulatory agencies, including the FDA and EMA, continue to endorse the use of the Omeprazole-based triple therapy as a first-line regimen in many countries but recommend local resistance testing to optimize treatment choices [4].

Market Analysis

Current Market Landscape

The global H. pylori eradication market, driven largely by the combined use of Omeprazole, Clarithromycin, and Amoxicillin, has seen steady growth, fueled by increasing prevalence of gastrointestinal disorders and heightened awareness.

• Market Valuation:
  In 2022, the market was valued at approximately USD 2.1 billion, with an expected Compound Annual Growth Rate (CAGR) of approximately 4.2% through 2030 [5].

• Regional Dynamics:
  Europe and North America dominate due to higher healthcare expenditure and widespread clinical adoption. Asia-Pacific exhibits rapid growth, owing to high infection prevalence and expanding healthcare infrastructure.

Drivers and Challenges

• Drivers:

  • Rising prevalence of H. pylori infection globally.
  • Favorable reimbursement policies for eradication therapies.
  • Increased awareness of gastric cancer linked to unmanaged infections.

• Challenges:

  • Growing antibiotic resistance diminishes therapeutic efficacy.
  • Variability in regional treatment guidelines.
  • Patent expiry of some formulations leading to generic proliferation and price erosion.

Market Players

Leading pharma companies include Johnson & Johnson, GlaxoSmithKline, and Takeda, with several generics manufacturers contributing to market penetration. The emergence of novel combination therapies and adjunctive agents (e.g., probiotics) signals potential market shifts.

Future Market Projection and Trends

Growth Outlook (2023–2030)

Considering the current resistance patterns and ongoing research, the market for Omeprazole and its combination therapies is projected to grow modestly at a CAGR of approximately 4.2%, reaching USD 3.2 billion by 2030.

Emerging Trends

• Personalized Therapy:
  Incorporation of resistance testing to tailor therapy is predicted to replace empiric treatment in high-resistance regions, enhancing success rates and reducing unnecessary antibiotic use.

• Novel Adjuncts:
  Trials exploring probiotics, bismuth-containing quadruple therapy, and newer acid suppressants indicate potential for expanding treatment options.

• Regulatory and Patent Dynamics:
  Patent expirations, especially for Omeprazole formulations, will likely fuel generics’ proliferation, lowering costs and improving accessibility.

• Shift Towards Non-Pharmacologic Interventions:
  Research into vaccines against H. pylori could reshape the landscape, though these are still in early stages.

Impact of Resistance and Compliance

The efficacy of current regimens is threatened by rising resistance, especially to Clarithromycin. This necessitates continuous innovation, including the development of resistance-proof formulations and combination strategies, to sustain market relevance.

Conclusion

The landscape of Omeprazole, Clarithromycin, and Amoxicillin combination therapy is characterized by robust clinical activity established over decades, but now challenged by increasing antibiot resistance and evolving treatment guidelines. While current market growth remains steady, future expansion hinges on addressing resistance, improving compliance, and adopting personalized therapy approaches. Regulatory bodies’ emphasis on resistance testing and precision medicine will shape the clinical deployment and commercial trajectory.

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Key Takeaways

• Clinical developments focus on overcoming clarithromycin resistance through extended treatment durations and newer PPIs, with emerging formulations aiming to enhance bioavailability and compliance.

• Market growth remains resilient but will face headwinds from rising resistance and generic competition, possibly accelerating adoption of personalized treatment guided by resistance profiling.

• Regional disparities in resistance and healthcare infrastructure will influence market dynamics, with Asia-Pacific presenting significant growth potential.

• Future trends include integrating molecular diagnostics into routine care, expanding the role of adjunctive therapies, and exploring vaccine development, all of which could influence the therapy landscape.

• Strategic focus for stakeholders should include investing in resistance mitigation strategies, innovating delivery mechanisms, and aligning with evolving guidelines emphasizing personalized medicine.

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FAQs

1. How does antibiotic resistance impact the efficacy of omeprazole-based triple therapy?
Rising clarithromycin resistance significantly decreases eradication success, prompting shifts to alternative regimens, longer durations, or resistance-guided therapy to maintain efficacy.

2. Are there newer drugs replacing omeprazole in H. pylori therapy?
While newer PPIs like Vonoprazan show promise due to potent acid suppression, omeprazole remains widely used owing to established efficacy and availability; ongoing trials compare these options.

3. What is the outlook for generic versions of these medications?
Patent expiries are driving increased availability of generics, decreasing costs but potentially impacting market revenues for branded formulations.

4. How soon might vaccine development impact current treatment paradigms?
H. pylori vaccines are still in early research phases, with clinical trialsfew. A widespread vaccine could significantly reduce infection rates within the next decade.

5. What role do diagnostic advancements play in optimizing therapy?
Molecular resistance testing enables tailored therapies, improving eradication rates and reducing unnecessary antibiotic exposure, aligning with personalized medicine trends.

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Sources:
[1] National Institute of Diabetes and Digestive and Kidney Diseases, ClinicalTrials.gov.
[2] Clinical efficacy comparison studies in Gastroenterology journals.
[3] Global Antibiotic Resistance Partnership (GARP) reports.
[4] FDA and EMA guidelines on H. pylori treatment.
[5] Market Research Future, "Helicobacter pylori Market Analysis."