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.
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.
NCT00206440 ↗	Nexium Study To Suppress Nausea During Chemotherapy	Terminated	AstraZeneca	Phase 3	2005-08-01	This study will look at a drug called esomeprazole, the newest PPI, as a way to further reduce the amount of nausea and vomiting seen in breast cancer patients receiving adriamycin or epirubicin chemotherapy. Esomeprazole may help protect the gut lining from the stomach acid and thus lessen the nausea and vomiting. If patients have less stomach sickness, they may be able to enjoy their daily routines much more while they are getting chemotherapy.

Clinical Trial Conditions for Omeprazole And Clarithromycin And Amoxicillin

Condition Name

Condition Name for Omeprazole And Clarithromycin And Amoxicillin
Intervention	Trials
Helicobacter Pylori Infection	16
Helicobacter Infections	3
Non-alcoholic Fatty Liver Disease	3
Gastritis	2

Condition MeSH

Condition MeSH for Omeprazole And Clarithromycin And Amoxicillin
Intervention	Trials
Helicobacter Infections	13
Infections	7
Communicable Diseases	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
Egypt	5
United States	5
Iran, Islamic Republic of	4
Spain	4
Pakistan	4

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	2
PHASE3	1
PHASE2	3

Clinical Trial Status

Clinical Trial Status for Omeprazole And Clarithromycin And Amoxicillin
Clinical Trial Phase	Trials
Completed	24
Unknown status	8
NOT_YET_RECRUITING	4

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
Tanta University	2
National Taiwan University Hospital	2

Sponsor Type

Sponsor Type for Omeprazole And Clarithromycin And Amoxicillin
Sponsor	Trials
Other	56
Industry	6
NIH	1

OMEPRAZOLE + CLARITHROMYCIN + AMOXICILLIN (Triple Therapy) Clinical Trials Update and Market Projection

Last updated: April 23, 2026

What is the product and what does the regimen treat?

Omeprazole + clarithromycin + amoxicillin is a three-drug regimen used to eradicate Helicobacter pylori (H. pylori) and treat H. pylori–associated peptic ulcer disease. The standard of care is a proton pump inhibitor (PPI) plus two antibiotics, with omeprazole providing acid suppression and clarithromycin plus amoxicillin delivering antibacterial activity.

The regimen is widely commercialized under multiple brand and generic formulations in fixed-dose or multi-bottle formats, depending on jurisdiction.

How is the clinical evidence evolving?

Current clinical development activity around this exact combination is generally lower than for newer H. pylori strategies because the regimen is established. Recent evidence focuses on (1) eradication outcomes by geography due to rising clarithromycin resistance, and (2) how triple therapy compares to non-clarithromycin regimens, such as bismuth quadruple therapy or concomitant therapy.

Key clinical themes in the modern literature:

• Clarithromycin resistance drives lower eradication rates in regions with high resistance prevalence.
• Local resistance-informed selection improves outcomes versus empiric use.
• Duration and adherence affect success, with many guidelines preferring longer courses (commonly 10 to 14 days in many settings) versus older 7-day courses, depending on the country.

Which randomized or guideline-backed conclusions matter for adoption?

Major guidelines and evidence syntheses converge on the same decision logic: use clarithromycin-based triple therapy where clarithromycin resistance is low or where resistance is known to be favorable, otherwise prefer alternative regimens.

The most operationally relevant summary for market adoption is:

• Triple therapy demand is structurally constrained in high-resistance markets.
• Penetration is highest where clarithromycin resistance is low or where testing guides regimen choice.

Sources anchor these conclusions in guideline recommendations and systematic evidence: the Maastricht VI/Florence consensus on management of H. pylori and large-scale guideline review processes. [1,2]

What do recent guidance documents imply for prescribing?

Guideline-driven prescribing environment

The Maastricht VI/Florence consensus emphasizes resistance-aware selection and supports alternative first-line strategies in areas with higher clarithromycin resistance. [1] The general global guideline trend is consistent: triple therapy is less preferred as resistance increases.

This matters commercially because:

• Payers and clinicians shift to regimens with higher expected eradication probability.
• Uptake becomes more conditional and less uniform across countries.
• Forecasts must incorporate regional prescribing share by resistance profile.

Where triple therapy still wins

Triple therapy maintains a role where:

• Clarithromycin resistance prevalence is low.
• Testing supports clarithromycin sensitivity.
• Patients have access and clinicians have established workflow for the regimen.

How large is the market and what segments drive demand?

The economic market for this regimen is best modeled as a subset of the H. pylori eradication therapeutics market rather than a standalone “triple therapy-only” market, because:

• Many units are prescribed based on guideline choice among competing regimens.
• Market share depends on resistance rates and treatment duration.

Demand drivers

• Prevalence of H. pylori infection and peptic ulcer disease burden.
• Guideline recommendations affecting first-line selection.
• Antibiotic stewardship pressure that can limit empiric clarithromycin use where resistance is high.
• Shelf availability and generic pricing which keeps treatment affordable and broad-based.

Supply and competition

• The regimen is dominated by generics in most major markets.
• Brand-based pricing power is limited compared with newer eradication regimens.

What is the current competitive set replacing triple therapy?

The main substitutes include:

• Bismuth quadruple therapy (PPI + bismuth + tetracycline + metronidazole)
• Concomitant therapy (PPI + clarithromycin + amoxicillin + metronidazole)
• Sequential therapy (PPI + amoxicillin then PPI + clarithromycin + metronidazole)
• Levofloxacin-containing regimens in certain geographies
• Rifabutin-based and other rescue strategies in refractory cases

These alternatives generally win in markets with higher clarithromycin resistance because they maintain higher eradication probability even when clarithromycin fails.

Clinical trials update: what should investors track next?

There is no indication that a new breakthrough mechanism is emerging for the specific triple combination. The pragmatic “trial-to-forecast” logic for this category is:

• Track regional eradication outcomes tied to local clarithromycin resistance trends.
• Track guideline updates that move triple therapy between first-line and “conditional” use.
• Track increasing adoption of rescue regimens for treatment failures after initial exposure to clarithromycin.

The strongest evidence base for this market behavior comes from guideline guidance on regimen selection by resistance risk and the persistent decline in effectiveness of clarithromycin-based regimens in high-resistance geographies. [1,2]

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Market projection: how should growth be modeled?

Because this regimen is mature, a credible projection uses three layers:

1. Macro demand: H. pylori testing and eradication treatment volumes.
2. Regimen share: first-line and rescue-line penetration of this specific combination.
3. Price: declining or stabilized generic pricing across regions.

Projection logic (directional)

• Unit growth will track broader H. pylori management trends (diagnosis, endoscopy volumes, test-and-treat strategies).
• Share for this regimen will likely soften in high clarithromycin resistance markets as guidance favors other regimens.
• Share will hold better in low-resistance regions where triple therapy remains guideline-consistent.

Three-scenario market view (global directional)

Scenario	Clarithromycin resistance trend	Guideline stance on triple therapy	Expected net result for this regimen
Base case	Moderate resistance increase	Conditional first-line, stronger rescue positioning	Low-to-mid single-digit global unit growth; slow value growth
High resistance	Rapid resistance increase	Triple therapy moved to testing-dependent or second-line	Declining share; value pressure; units shift to quadruple/concomitant
Low resistance / testing adoption	Stable or improving resistance profile + test-and-treat	Triple therapy stays first-line in more geographies	Stronger share retention; units and value grow closer to underlying market

This scenario framework matches guideline logic around resistance-aware regimen selection and the observed erosion of clarithromycin-based outcomes where resistance is high. [1,2]

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Patent and regulatory posture: why this matters for pricing and market shape

For investment and supply-chain forecasting, the regimen behaves like a classic mature generic class:

• Competition drives low pricing and high volume.
• Value growth depends primarily on treatment volume and mix (treatment duration, first-line vs rescue).
• New clinical differentiation is typically incremental (resistance-aware selection) rather than a new chemical entity.

Accordingly, most revenue forecasting should be tied to prescribing share and antibiotic resistance patterns, not to new “pipeline” approvals.

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Key market milestones to monitor

1. Guideline updates that alter first-line regimen preference based on resistance thresholds. [1,2]
2. National resistance surveillance reports that quantify clarithromycin susceptibility by country and region.
3. Local antimicrobial stewardship policies that restrict empiric clarithromycin use.
4. Adoption of test-and-treat pathways (serology, stool antigen, urea breath) that increase treated volumes but may shift regimen choice based on resistance testing availability.

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Key Takeaways

• Omeprazole + clarithromycin + amoxicillin is a mature, guideline-driven H. pylori eradication regimen.
• Clinical evolution is less about new trial registrations for the exact combo and more about declining performance in clarithromycin-resistant geographies and resistance-aware prescribing. [1,2]
• Market outlook is dominated by generic economics and regimen share, which is constrained as clarithromycin resistance rises.
• Projection should model growth through diagnosis/treatment volumes plus resistance-dependent shifts toward bismuth quadruple and other non-clarithromycin options.

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FAQs

1) Is omeprazole + clarithromycin + amoxicillin still recommended?

Yes, but it is typically recommended as a first-line option only in contexts where clarithromycin resistance is low or susceptibility is known. [1,2]

2) What is the main clinical reason triple therapy loses share?

Rising clarithromycin resistance, which reduces eradication rates and pushes clinicians toward regimens with higher resistance robustness. [1,2]

3) Does treatment duration affect eradication outcomes?

Yes. Longer courses commonly improve eradication versus shorter historical regimens, and duration is incorporated into guideline-specific prescribing. [1]

4) What regimens compete most directly with this triple therapy?

Bismuth quadruple therapy and concomitant therapy are the primary substitutes in modern practice patterns, especially in higher resistance settings. [1,2]

5) What drives revenue for this mature regimen?

Primary drivers are H. pylori treatment volume, first-line versus rescue positioning, and generic price levels, with resistance patterns determining regimen share. [1,2]

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References

[1] Gatta L, Bazzoli F, et al. Maastricht VI/Florence Consensus Report on the Management of Helicobacter pylori Infection. Gut. 2022.
[2] Malfertheiner P, Megraud F, et al. Management of Helicobacter pylori infection: the Maastricht VI/Florence consensus and related guideline evidence. (Guideline consensus evidence base). 2022.