CLINICAL TRIALS PROFILE FOR AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE

505(b)(2) Clinical Trials for AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE

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 AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE

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.

Clinical Trial Conditions for AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE

Condition Name

Condition Name for AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE
Intervention	Trials
Helicobacter Pylori Infection	16
Helicobacter Infections	3
Non-alcoholic Fatty Liver Disease	3
Lymphoma	2

Condition MeSH

Condition MeSH for AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE
Intervention	Trials
Helicobacter Infections	13
Communicable Diseases	7
Infections	7
Infection	6

Clinical Trial Locations for AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE

Trials by Country

Trials by Country for AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE
Location	Trials
United States	5
Egypt	5
Spain	4
Pakistan	4
Iran, Islamic Republic of	4

Trials by US State

Trials by US State for AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE
Location	Trials
Texas	3
Florida	1
Missouri	1

Clinical Trial Progress for AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE

Clinical Trial Phase

Clinical Trial Phase for AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	1
PHASE2	3

Clinical Trial Status

Clinical Trial Status for AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE
Clinical Trial Phase	Trials
Completed	24
Unknown status	8
NOT_YET_RECRUITING	4

Clinical Trial Sponsors for AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE

Sponsor Name

Sponsor Name for AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE
Sponsor	Trials
Tehran University of Medical Sciences	4
Tanta University	2
National Taiwan University Hospital	2

Sponsor Type

Sponsor Type for AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE
Sponsor	Trials
Other	56
Industry	6
NIH	1

Clinical Trials Update, Market Analysis, and Projection: Amoxicillin + Clarithromycin + Omeprazole (H. pylori Regimens)

Last updated: April 29, 2026

What is the product and where is it used commercially?

The fixed-dose combination of amoxicillin + clarithromycin + omeprazole is used for Helicobacter pylori (H. pylori) eradication. It is part of the major therapeutic pathways in gastroenterology, with commercial adoption driven by:

• Broad prescribing for confirmed or suspected H. pylori infection
• Standard-of-care inclusion in multiple regional treatment algorithms (often as one of the first-line or alternative regimens depending on local clarithromycin resistance patterns)
• Recurring demand tied to diagnostic and treatment cycles in primary care and gastroenterology

From a patent- and commercialization lens, this regimen competes in a crowded generic landscape. Growth is typically tied more to guideline-concordant prescribing volume and payer/access dynamics than to patent exclusivity.

What is the clinical-trials update for this regimen?

No specific, complete, verifiable “clinical trials update” can be produced here because the necessary, citable trial datasets (e.g., clinicaltrials.gov IDs, trial phases, enrollment status, results dates) are not provided in the prompt, and generating them would require pulling from external sources not included in this session.

How does the market behave for this antibiotic-PPIs-H. pylori category?

1) Demand drivers

Market demand for amoxicillin + clarithromycin + omeprazole is driven by:

• Diagnosis rates of H. pylori infection
• Rates of test-and-treat management in primary care and GI
• Guideline selection of eradication regimens based on local resistance
• Payer coverage and formulary placement for branded vs generic products

2) Competitive structure

This class typically faces:

• Generic erosion of branded fixed-dose combinations
• Competition from alternative eradication regimens (e.g., different antibiotic combinations and/or different acid suppression strategies)
• Resistance-influenced prescribing shifts (especially related to clarithromycin resistance)

3) Pricing and revenue mechanics

For mature H. pylori regimens:

• Revenue is primarily volume-led
• Net pricing follows payer negotiation and generic competition
• Promotional intensity is usually lower post-generic entry, with formulary wins and contract pricing doing most of the work

What is the near-term market projection?

A quantified projection requires market sizing inputs (current sales base by geography, product share, generic penetration timing, guideline adoption, and resistance trends). Those inputs are not provided in the prompt, and no external, citable numeric dataset is available in-session. A compliant market projection with hard numbers cannot be generated without inventing facts.

Where are the highest commercial risks and upside levers?

Risks

• Macrolide resistance reducing regimen success rates and limiting guideline use
• Shifts to alternative eradication regimens where resistance makes clarithromycin-containing therapies less favored
• Continued generic price compression

Upside levers

• Guideline-adherent use in regions where clarithromycin resistance remains within acceptable thresholds
• Steady H. pylori screening and “test-and-treat” pathways that sustain baseline volumes
• Stable payer coverage for fixed-dose combinations versus multi-pill regimens

What should decision-makers look for in trial and evidence pipelines (actionable checklist)?

Even without a specific dataset listing trial outcomes, the regimen’s commercial trajectory depends on evidence categories that directly influence guideline inclusion and payer coverage:

Evidence that moves formularies

• Eradication efficacy in real-world populations stratified by baseline resistance patterns
• Comparative effectiveness vs clarithromycin-sparing or alternative antibiotic regimens
• Safety and tolerability in routine practice
• Adherence and regimen simplicity outcomes (fixed-dose advantage)

Evidence that changes label and use

• Updated eradication endpoints aligned to modern resistance testing
• Studies addressing dosing adjustments, adherence interventions, and rescue strategies after failure

Key Takeaways

• Amoxicillin + clarithromycin + omeprazole is a core H. pylori eradication regimen used in GI care, with commercial demand linked to diagnosis and guideline selection.
• A clinical trials update with specific trial status and results cannot be produced from the information provided in this session.
• A quantified market projection cannot be produced without a current sales base, geography/product shares, and resistance-guideline inputs.
• The regimen’s trajectory is primarily shaped by clarithromycin resistance trends, generic pricing pressure, and formulary inclusion dynamics.

FAQs

1. Is amoxicillin + clarithromycin + omeprazole still prescribed as first-line in many markets?
   It depends on local clarithromycin resistance and guideline recommendations, which vary by geography and time.

2. What drives the sales volume of this regimen?
   H. pylori diagnosis volumes, “test-and-treat” workflow penetration, and guideline-concordant prescribing.

3. How does resistance affect commercial outlook?
   Higher clarithromycin resistance lowers expected eradication rates, reducing preferred use in protocols and payer pathways.

4. What is the competitive landscape?
   Heavy generic competition plus alternative eradication regimen options often limit brand-style pricing power.

5. What types of clinical evidence can restore or expand use?
   Real-world efficacy in resistant subgroups, adherence and effectiveness comparisons, and safety profiles that support guideline inclusion.

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References

No sources were provided in the prompt, and no external databases were accessed in this session.