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Last Updated: January 5, 2025

CLINICAL TRIALS PROFILE FOR AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE


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All Clinical Trials for AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE

Trial ID Title Status Sponsor Phase Start Date Summary
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.
NCT00149084 ↗ Tailored Treatment of H. Pylori Infection Based Polymorphisms of CYP2C19 and 23S rRNA of H. Pylori Unknown status Hamamatsu University 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.
NCT00281047 ↗ The Influence of FP-10 on the Eradication Rates of H. Pylori by a Triple Therapy Unknown status Oita University Phase 2/Phase 3 2006-01-01 FP-10 is a food ingredient derived from milk casein. FP-10 can inhibit H. pylori to attach to the gastric epithelium. FP-10 has been made clear to decrease the intragastric urease activity (which is assumed to be produced by H. pylori) measured by the urea breath test. FP-10 can also detach H. pylori from gastric epithelium. We have hypothesized that FP-10 increases the eradication rates by a triple therapy with a proton pump inhibitor, amoxicillin, and clarithromycin.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE

Condition Name

Condition Name for AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE
Intervention Trials
Helicobacter Pylori Infection 9
Helicobacter Pylori 3
Dyspepsia 2
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Condition MeSH

Condition MeSH for AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE
Intervention Trials
Helicobacter Infections 10
Communicable Diseases 6
Infections 6
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Clinical Trial Locations for AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE

Trials by Country

Trials by Country for AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE
Location Trials
United States 26
Japan 20
Taiwan 6
Korea, Republic of 3
Mexico 2
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Trials by US State

Trials by US State for AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE
Location Trials
California 1
Arkansas 1
Arizona 1
Alabama 1
Washington 1
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Clinical Trial Progress for AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE

Clinical Trial Phase

Clinical Trial Phase for AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE
Clinical Trial Phase Trials
Phase 4 11
Phase 3 7
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE
Clinical Trial Phase Trials
Completed 14
Unknown status 4
Recruiting 3
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Clinical Trial Sponsors for AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE

Sponsor Name

Sponsor Name for AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE
Sponsor Trials
National Taiwan University Hospital 4
HK inno.N Corporation 2
Hamamatsu University 2
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Sponsor Type

Sponsor Type for AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE
Sponsor Trials
Other 26
Industry 10
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AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE Market Analysis and Financial Projection

Clinical Trials, Market Analysis, and Projections for Amoxicillin, Clarithromycin, and Lansoprazole

Introduction

Amoxicillin, clarithromycin, and lansoprazole are widely used medications, each with distinct therapeutic applications. This article delves into current clinical trials, market analysis, and future projections for these drugs, highlighting their uses, interactions, and the evolving landscape of antibiotic and gastrointestinal treatment.

Clinical Trials Update

Amoxicillin

Antibiotic-Associated Diarrhea and Gut Health

A recent clinical trial focused on the impact of amoxicillin on gut health in healthy individuals. This Phase 4 trial, conducted by Rockefeller University, aims to understand how short-term amoxicillin use affects gut nerve and support cells, potentially leading to conditions like irritable bowel syndrome. The trial involves healthy controls and has a timeline that includes a 3-week screening period, variable treatment duration, and a 1-year follow-up[1].

Clarithromycin and Amoxicillin in Combination Therapy

Helicobacter pylori Eradication

Studies have been conducted to evaluate the efficacy of combination therapies involving clarithromycin and amoxicillin, often in conjunction with proton pump inhibitors (PPIs) like lansoprazole or pantoprazole. A multicenter study found that the combination of pantoprazole or lansoprazole with amoxicillin and clarithromycin achieved H. pylori eradication rates of approximately 70% and 69.2%, respectively, in patients with functional dyspepsia[2].

Drug-Drug Interactions

Pharmacokinetics of Combination Therapies

Research on the pharmacokinetics of these drugs when used together has shown significant interactions. For instance, the concomitant administration of lansoprazole, amoxicillin, and clarithromycin slightly elevates amoxicillin concentrations, though not statistically significant. However, it significantly prolongs the elimination half-life and increases the AUC of lansoprazole and the active metabolite of clarithromycin[5].

Market Analysis

Current Market Landscape

Antibiotic Resistance and Pipeline

The current antibiotic pipeline is under pressure due to increasing resistance. There is only one antibiotic candidate in Phase III clinical trials for critical priority bacterial pathogens. Without additional incentives, the pipeline is expected to decline, with only 26 treatments anticipated in 10 years, of which only six will be in late stages of development[4].

Market Demand and Economic Imperatives

The economic and health imperatives to strengthen the antibiotic pipeline are clear. Effective pull incentives could attract significant investment, leading to a substantial increase in new antibiotics and a more robust pipeline. This could result in 19 new antibiotics approved and a pipeline of 72 treatments in various stages of clinical research over the next decade[4].

Projections and Future Outlook

Antibiotic Pipeline Evolution

Scenario Analysis

Two scenarios predict the future of the antibiotic pipeline:

  • Scenario One: Without new incentives, the pipeline will decline, leading to a shortage of effective antibiotics.
  • Scenario Two: With effective pull incentives, the pipeline will strengthen, attracting significant investment and resulting in a substantial increase in new antibiotics[4].

Market Impact of Drug Interactions

Pharmacokinetic Modeling

The use of physiologically based pharmacokinetic (PBPK) modeling can predict drug interactions, such as those between tegoprazan, amoxicillin, and clarithromycin. This modeling helps in understanding the impact of co-administration on drug concentrations and can support the choice of appropriate drug therapy[3].

Key Applications and Uses

Amoxicillin

  • Antibiotic-Associated Diarrhea: Amoxicillin is being studied for its effects on gut health and potential to cause or mitigate antibiotic-associated diarrhea.
  • H. pylori Eradication: Amoxicillin is a key component in combination therapies for eradicating H. pylori.

Clarithromycin

  • H. pylori Eradication: Clarithromycin is commonly used in combination with PPIs and amoxicillin to treat H. pylori infections.
  • Respiratory Infections: Clarithromycin is also used to treat various respiratory infections.

Lansoprazole

  • Gastroesophageal Reflux Disease (GERD): Lansoprazole is used to treat GERD and other conditions involving excessive stomach acid.
  • H. pylori Eradication: Lansoprazole is used in combination with amoxicillin and clarithromycin to eradicate H. pylori.

Challenges and Opportunities

Antibiotic Resistance

The increasing resistance to antibiotics like clarithromycin poses a significant challenge. The development of new antibiotics and the optimization of current treatment regimens are critical to addressing this issue[4].

Drug-Drug Interactions

Understanding and managing drug-drug interactions, such as those between amoxicillin, clarithromycin, and lansoprazole, are essential for optimizing treatment outcomes and minimizing adverse effects[5].

Key Takeaways

  • Clinical Trials: Ongoing trials are investigating the effects of amoxicillin on gut health and the efficacy of combination therapies involving clarithromycin and amoxicillin.
  • Market Analysis: The antibiotic pipeline faces significant challenges due to resistance, but incentives could lead to a robust increase in new antibiotics.
  • Future Outlook: PBPK modeling and scenario analysis suggest that with the right incentives, the antibiotic pipeline can be strengthened, leading to better treatment options.
  • Key Applications: These drugs are crucial in treating H. pylori infections, antibiotic-associated diarrhea, and various gastrointestinal and respiratory conditions.

FAQs

Q: What is the current focus of clinical trials involving amoxicillin?

A: Current clinical trials are focusing on how amoxicillin affects gut health in healthy individuals and its role in combination therapies for H. pylori eradication.

Q: How effective are combination therapies involving clarithromycin, amoxicillin, and lansoprazole in eradicating H. pylori?

A: These combination therapies have been shown to achieve H. pylori eradication rates of approximately 70% in patients with functional dyspepsia.

Q: What are the implications of drug-drug interactions between these medications?

A: Drug-drug interactions can significantly affect the pharmacokinetics of these drugs, leading to changes in their concentrations and efficacy.

Q: What are the projections for the future of the antibiotic pipeline?

A: Without new incentives, the pipeline is expected to decline, but with effective pull incentives, it could strengthen significantly, leading to more new antibiotics.

Q: How do these drugs interact in terms of pharmacokinetics?

A: The concomitant administration of lansoprazole, amoxicillin, and clarithromycin can lead to significant changes in the pharmacokinetics of these drugs, such as prolonged elimination half-life and increased AUC.

Sources

  1. Withpower.com: Amoxicillin for Antibiotic-Associated Diarrhea - Clinical Trials.
  2. Turkjgastroenterol.org: Recent success of pantoprazole- or lansoprazole-based clarithromycin plus amoxicillin treatment in the eradication of Helicobacter pylori.
  3. MDPI.com: Drug Interaction Potential between Tegoprazan and Amoxicillin.
  4. IFPMA.org: From resistance to resilience: what could the future antibiotic pipeline look like?
  5. OUP.com: Pharmacokinetics of lansoprazole, amoxicillin and clarithromycin.

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