You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for Lansoprazole, Amoxicillin And Clarithromycin

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

Clinical Trial Conditions for Lansoprazole, Amoxicillin And Clarithromycin

Condition Name

Condition Name for Lansoprazole, Amoxicillin And Clarithromycin
Intervention Trials
Helicobacter Pylori Infection 9
Helicobacter Pylori 3
Dyspepsia 2
Gastritis 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Lansoprazole, Amoxicillin And Clarithromycin
Intervention Trials
Helicobacter Infections 10
Communicable Diseases 6
Infections 6
Infection 6
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Lansoprazole, Amoxicillin And Clarithromycin

Trials by Country

Trials by Country for Lansoprazole, Amoxicillin And Clarithromycin
Location Trials
United States 26
Japan 20
Taiwan 6
Korea, Republic of 3
Mexico 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Lansoprazole, Amoxicillin And Clarithromycin
Location Trials
Arizona 1
Alabama 1
Washington 1
Virginia 1
Utah 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Lansoprazole, Amoxicillin And Clarithromycin

Clinical Trial Phase

Clinical Trial Phase for Lansoprazole, Amoxicillin And Clarithromycin
Clinical Trial Phase Trials
Phase 4 11
Phase 3 7
Phase 2/Phase 3 1
[disabled in preview] 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Lansoprazole, Amoxicillin And Clarithromycin
Clinical Trial Phase Trials
Completed 14
Unknown status 4
Recruiting 3
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Lansoprazole, Amoxicillin And Clarithromycin

Sponsor Name

Sponsor Name for Lansoprazole, Amoxicillin And Clarithromycin
Sponsor Trials
National Taiwan University Hospital 4
HK inno.N Corporation 2
Hamamatsu University 2
[disabled in preview] 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Lansoprazole, Amoxicillin And Clarithromycin
Sponsor Trials
Other 26
Industry 10
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Lansoprazole, Amoxicillin, and Clarithromycin: A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction

The combination of lansoprazole, amoxicillin, and clarithromycin is a widely used triple therapy for the eradication of Helicobacter pylori (H. pylori) infections, particularly in patients with gastric or duodenal ulcers. This article provides an update on the clinical trials, market analysis, and future projections for this therapeutic regimen.

Clinical Trials Overview

Efficacy in H. pylori Eradication

Several clinical trials have demonstrated the efficacy of the lansoprazole, amoxicillin, and clarithromycin combination in eradicating H. pylori. A notable study compared 10 and 14 days of this triple therapy, showing that the 14-day regimen was highly effective, with an eradication rate of up to 94%[4].

Comparative Studies

A clinical trial conducted from January 2012 to June 2013 compared the efficacy of TAK-438, amoxicillin, and clarithromycin with the standard lansoprazole, amoxicillin, and clarithromycin regimen. This study enrolled 650 participants and aimed to confirm the non-inferiority of the TAK-438-based regimen. However, the lansoprazole-based regimen remains a gold standard due to its established efficacy[1].

Success Rates and Resistance

Recent studies have assessed the current success rates of PPI-based triple regimens, including lansoprazole or pantoprazole, amoxicillin, and clarithromycin. These studies indicate that while the eradication rates are still significant, there is a growing concern about clarithromycin resistance. For example, one study reported eradication rates of 70% and 69.2% for pantoprazole and lansoprazole-based regimens, respectively, highlighting the need for continuous monitoring of antibiotic resistance[2].

Market Analysis

Market Demand

The demand for H. pylori eradication therapies remains high due to the prevalence of gastric and duodenal ulcers. The global market for gastrointestinal drugs, including PPIs and antibiotics, is substantial and continues to grow driven by increasing incidence rates and the need for effective treatments.

Competitive Landscape

The market for H. pylori eradication therapies is competitive, with several PPIs and antibiotic combinations available. Lansoprazole, amoxicillin, and clarithromycin remain a preferred choice due to their well-established efficacy and safety profile. However, emerging alternatives, such as TAK-438-based regimens, are being explored to address the issue of antibiotic resistance.

Pricing and Accessibility

The cost of the lansoprazole, amoxicillin, and clarithromycin combination can vary depending on the region and availability of generic versions. Generally, this regimen is considered cost-effective compared to other treatment options, making it accessible to a wide range of patients.

Projections and Future Outlook

Addressing Antibiotic Resistance

One of the key challenges facing the continued use of this regimen is the increasing resistance to clarithromycin. Future projections suggest that there will be a greater emphasis on developing and using alternative antibiotics or combination therapies that can overcome this resistance.

New Therapeutic Approaches

Research is ongoing to develop new therapeutic approaches, including the use of different PPIs like tegoprazan, which may offer better pharmacokinetic profiles and reduced drug-drug interactions. For instance, studies on the interaction between tegoprazan and amoxicillin/clarithromycin indicate potential benefits in terms of pharmacokinetics and pharmacodynamics[3].

Regulatory and Clinical Developments

Regulatory bodies are likely to continue monitoring the efficacy and safety of existing regimens while encouraging the development of new treatments. Clinical trials will remain crucial in evaluating the effectiveness of new combinations and ensuring they meet the necessary safety and efficacy standards.

Patient Considerations

Dosage and Administration

The recommended adult oral dose for this triple therapy typically includes 30 mg of lansoprazole, 500 mg of clarithromycin, and 1000 mg of amoxicillin, all given twice daily for 7, 10, or 14 days. Patients with renal or hepatic impairment may require adjusted dosages, and healthcare providers must carefully consider these factors when prescribing the treatment[5].

Side Effects and Safety

Common side effects include gastrointestinal disturbances, allergic reactions, and interactions with other medications. Long-term use of lansoprazole has been associated with slight increases in ECL-cell density, but these changes are generally not clinically significant[5].

Key Takeaways

  • Efficacy: The lansoprazole, amoxicillin, and clarithromycin combination is highly effective in eradicating H. pylori infections.
  • Market Demand: The demand for this regimen remains strong due to the prevalence of gastric and duodenal ulcers.
  • Competitive Landscape: The market is competitive, but this combination remains a preferred choice due to its established efficacy and safety profile.
  • Future Outlook: Addressing antibiotic resistance and developing new therapeutic approaches are key areas of focus.
  • Patient Considerations: Careful consideration of dosage, administration, and potential side effects is essential.

FAQs

Q: What is the typical dosage for the lansoprazole, amoxicillin, and clarithromycin combination?

A: The typical dosage includes 30 mg of lansoprazole, 500 mg of clarithromycin, and 1000 mg of amoxicillin, all given twice daily for 7, 10, or 14 days.

Q: How effective is this combination in eradicating H. pylori?

A: This combination has been shown to be highly effective, with eradication rates of up to 94% in some studies.

Q: What are the common side effects of this treatment?

A: Common side effects include gastrointestinal disturbances, allergic reactions, and interactions with other medications.

Q: How does antibiotic resistance affect the use of this regimen?

A: Increasing resistance to clarithromycin is a significant concern, prompting the need for alternative therapies and continuous monitoring.

Q: Are there any new therapeutic approaches being developed?

A: Yes, research is ongoing to develop new therapeutic approaches, including the use of different PPIs and antibiotics to address the issue of antibiotic resistance.

Sources

  1. Takeda Clinical Trials. Efficacy of TAK-438, Amoxicillin and Clarithromycin in the First Line Eradication of H. Pylori.
  2. Turkish Journal of Gastroenterology. Recent success of pantoprazole -or lansoprazole- based clarithromycin plus amoxicillin treatment in the eradication of Helicobacter pylori.
  3. MDPI. Drug Interaction Potential between Tegoprazan and Amoxicillin.
  4. JAMA Internal Medicine. A Comparison of 10 and 14 Days of Lansoprazole Triple Therapy for Helicobacter pylori Eradication.
  5. AA Pharma. Lansoprazole/amoxicillin/clarithromycin.

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.