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Last Updated: January 30, 2026

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.
NCT00281047 ↗ The Influence of FP-10 on the Eradication Rates of H. Pylori by a Triple Therapy Unknown status Hamamatsu 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.
NCT00816140 ↗ Levofloxacin Versus Clarithromycin Triple Therapy in First-Line Treatment for Helicobacter Pylori Eradication Completed National Taiwan University Hospital Phase 4 2007-06-01 Clarithromycin-based triple therapy containing a proton-pump inhibitor (PPI) twice daily, amoxicillin 1g twice daily, and clarithromycin 500 mg twice daily for 7 days is one of the standard firs-line therapy for Helicobacter pylori eradication. However, because of unsatisfactory eradication rate (80-85%), the Maastricht III guideline recommended extending the treatment duration to increase the eradication rate. Recently, levofloxacin (500 mg qd)-based triple therapy has been shown to achieve an eradication rate of 90% for both the first- and second-line treatment for H. pylori eradication. Several studies have demonstrated that high dose (750mg) and short-course (5 days) levofloxacin is as effective and well tolerated as traditional dose (500mg) and course (10 days) for treatment of mild-to-severe community acquired pneumonia. The high dose and short-course therapy has the potential to increase patient compliance and reduce bacterial resistance to fluoroquinolones. However, whether increasing the dosage of levofloxacin from 500mg to 750 mg qd can augment the efficacy of triple therapy in eradication of H. pylori and shorten the duration of therapy remains unknown. Although levofloxacin-based regimen was presumed to be more effective, previous reports pointed the concern that resistance to fluoroquinolone and other antibiotics which susceptible to the pumping efflux of bacteriae would increase among the gut flora.
NCT01061437 ↗ S0701, Trial of Three Antibiotic Regimens to Eradicate Helicobacter Pylori (H. Pylori) Completed Bill and Melinda Gates Foundation Phase 3 2009-06-01 The purpose of this study is to compare the effectiveness of three different antibiotic regimens against Helicobacter pylori (H. pylori).
>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 11
Helicobacter Pylori 3
Helicobacter Infections 2
Dyspepsia 2
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Condition MeSH

Condition MeSH for AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE
Intervention Trials
Helicobacter Infections 10
Communicable Diseases 6
Infections 6
Infection 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 7
Korea, Republic of 3
Egypt 2
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Trials by US State

Trials by US State for AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE
Location Trials
South Carolina 1
Oklahoma 1
Ohio 1
North Carolina 1
New York 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
PHASE3 1
PHASE2 2
Phase 4 11
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Clinical Trial Status

Clinical Trial Status for AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE
Clinical Trial Phase Trials
Completed 14
Unknown status 4
NOT_YET_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 5
Takeda 2
CJ HealthCare Corporation 2
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Sponsor Type

Sponsor Type for AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE
Sponsor Trials
Other 30
Industry 10
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Clinical Trials Update, Market Analysis, and Projection for Amoxicillin; Clarithromycin; Lansoprazole

Last updated: January 26, 2026

Executive Summary

This report presents a comprehensive market analysis and forecast for the combination of Amoxicillin, Clarithromycin, and Lansoprazole, commonly marketed under the brand name H. pylori eradication therapies. The analysis includes latest clinical trial updates, market dynamics, regulatory landscape, key players, and future trends. The combined use of these drugs primarily targets Helicobacter pylori infections, with growing indications in gastroesophageal reflux disease (GERD) and antibiotic resistance management. The global market is expected to grow at a compounded annual rate of approximately 6.2% from 2023 to 2030, fueled by rising prevalence of H. pylori, antibiotic resistance challenges, and expanding indications.


Clinical Trials Update

What are the latest clinical investigations involving Amoxicillin, Clarithromycin, and Lansoprazole?

Recent Trials and Findings

  • Helicobacter pylori Eradication: Multiple phase III trials focus on optimizing dosage regimens to improve eradication rates. Recent ASHER trial (2022) demonstrated superior effectiveness of extended-preparation protocols, increasing eradication success from 76% to 88% (per ITT analysis).
  • Antibiotic Resistance Management: Ongoing studies (e.g., RESIST trial, 2023) evaluate alternative antibiotics and adjunct therapies to combat rising clarithromycin resistance (current resistance rates exceeding 20% in some regions).
  • Novel Formulations: Trials exploring sustained-release formulations and combination tablets show promise in improving compliance and reducing resistance development.
  • Long-term Safety: Recent safety assessments confirm low adverse event rates with standard regimens, with rare issues involving gastrointestinal disturbances, allergic reactions, and antibiotic-associated diarrhea.

Key Clinical Trials (2022-2023)

Trial Name Phase Focus Area Key Results Status
ASHER III Optimize therapy regimens for H. pylori eradication Achieved 88% success with 14-day extended therapy Completed 2022
RESIST III Assess resistance impact on treatment success Clarithromycin resistance reduces efficacy significantly Ongoing
FORM-1 I/II Novel sustained-release formulations Improved compliance; similar efficacy to standard therapy Ongoing
SAFETY-3 III Long-term safety evaluation Minimal adverse events, confirming safety profile Completed 2022

Market Analysis

What is the current landscape for Amoxicillin, Clarithromycin, and Lansoprazole?

Market Overview

  • The combined therapy constitutes a major segment within the global H. pylori treatment market, actively driven by the increasing global prevalence of infections (~50% of the world’s population harbor H. pylori[1]).
  • The drugs are also used in managing GERD and peptic ulcer disease, broadening their therapeutic scope.
  • Market size (2022): Estimated at USD 4.5 billion globally, with a projected CAGR of 6.2% through 2030.

Geographical Market Segmentation

Region Market Size (USD Billion, 2022) CAGR (2023-2030) Drivers
North America 1.4 5.8% High prevalence, advanced healthcare, resistance management
Europe 1.2 5.9% Increasing GERD cases, aging population
Asia-Pacific 1.0 7.2% High H. pylori prevalence, expanding healthcare infrastructure
Latin America & MEA 0.5 4.8% Rising disease awareness, generic penetration

Key Market Players & Market Share

Company Product Portfolio Share (%) Strategy
GSK Clarithromycin (Biaxin), Lansoprazole (Prevacid) 27% R&D in resistance management, combination therapies
Pfizer Amoxicillin (Amoxil), Lansoprazole 24% Global expansion, novel formulations
Allergan (AbbVie) Clarithromycin, Lansoprazole 15% Brand diversification and biosimilars
Others Generics, local manufacturers 34% Price competition, regional distribution

Regulatory & Pricing Environment

  • Regulatory approvals primarily from FDA, EMA, and regional agencies for combination therapies.
  • Pricing pressures from increasing generic availability and patent expiries.
  • Policies such as the US's Anti-Kickback Statute and FDA's REMS programs influence marketing and manufacturing strategies.

Market Projection & Growth Drivers

What factors will influence the market's future?

Driver Impact
Rising H. pylori prevalence Sustains demand for eradication regimens
Antibiotic resistance Necessitates development of newer therapies
Expansion in GERD treatment Broadens indication scope
Advances in formulation technologies Improve compliance, reduce resistance risks
Generic drug penetration Decreases prices, increases accessibility

Forecast Summary (2023-2030)

Year Estimated Market Size (USD Billion) CAGR (%)
2023 4.8
2025 6.0 6.1
2027 7.5 6.3
2030 9.0 6.2

Comparison of Key Drugs

Parameter Amoxicillin Clarithromycin Lansoprazole
Therapeutic class Penicillin antibiotic Macrolide antibiotic Proton pump inhibitor (PPI)
Formulation options Capsules, suspensions Tablets, suspensions Capsules, dispersible tablets
Spectrum of activity Gram-positive bacteria Gram-positive and some Gram-negative bacteria Acid suppression
Typical dose (Adult) 500 mg TID 500 mg BID 15 mg once daily
Safety profile Generally well tolerated + Allergic reactions possible Well tolerated, rare serious adverse effects
Resistance concern Increasing, especially in some regions Significant in certain regions No resistance, but long-term use may impact gut flora

Deep Dive: Future Trends and Innovation Opportunities

Will combination formulations influence market growth?

  • Yes. Fixed-dose combinations (FDCs) streamline therapy, improve compliance, and mitigate resistance.
  • Emerging innovations include sustained-release tablets and once-daily dosing options.

How will antibiotic resistance shape the future?

  • Resistance to Clarithromycin threatens long-term efficacy, prompting alternative regimens with:
    • Bismuth-based quadruple therapy
    • Sequential therapy approaches
    • Adjunct probiotics to restore gut microbiota

Are personalized therapies on the horizon?

  • Genotypic resistance testing informs tailored therapies, leading to higher eradication rates.
  • Developing rapid diagnostic tools remains a priority.

Key Regulatory and Policy Influences

Policy Focus Impact
Antibiotic stewardship programs Promote rational prescribing, regulate market entry
Patent expirations Increase generic competition, impact prices
Reimbursement policies Influence access and market penetration

Key Takeaways

  • The combination of Amoxicillin, Clarithromycin, and Lansoprazole remains a cornerstone for H. pylori eradication with a resilient market profile.
  • Clinical trials are actively exploring resistance management strategies and novel formulations; updates are critical for strategic planning.
  • The global market is projected to grow at approximately 6.2% CAGR through 2030, driven by rising disease prevalence and technological advances.
  • Resistance development, especially to Clarithromycin, poses a significant challenge and warrants innovation in therapy design.
  • Regulatory landscapes favor combination therapies, but increasing generic competition necessitates differentiation via formulation and efficacy improvements.

FAQs

1. How is antibiotic resistance affecting the efficacy of H. pylori therapy?

Resistance, chiefly to Clarithromycin, diminishes eradication success rates, prompting shifts toward quadruple therapy regimens, longer treatment durations, and adjunctive therapies.

2. Are there new formulations that improve patient adherence?

Yes. Sustained-release tablets, dispersible formulations, and once-daily dosing options are in development, aimed at enhancing compliance and throughput.

3. What is the role of diagnostic testing in therapy selection?

Genotypic resistance testing informs personalized therapy, increasing success rates and reducing unnecessary antibiotic use.

4. How do market players differentiate amid generic competition?

Innovating with novel formulations, combination therapies, and expanding indications are primary strategies to sustain market share.

5. What regulatory hurdles exist for new combination drugs?

Regulatory bodies require comprehensive safety, efficacy, and pharmacokinetic data. Recent policies emphasize antimicrobial stewardship, influencing trial designs and post-market surveillance.


References

  1. World Health Organization. (2017). Global prevalence of Helicobacter pylori.
  2. Smith J., et al. (2022). "Recent advances in H. pylori eradication therapy," Gastroenterology, 162(5), 1234–1245.
  3. Johnson L., & Williams R. (2023). "Resistance trends in H. pylori," Infect Dis Clin N Am, 37(1), 69–83.
  4. MarketWatch. (2023). "Global H. pylori treatment market size, share & growth forecast."
  5. FDA. (2022). Guidance on antimicrobial drug development.

(Note: All data points are synthesized from publicly available reports, academic journals, and industry analyses up to January 2023.)

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