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	13
Non-alcoholic Fatty Liver Disease	3
Helicobacter Infections	3
Gastritis	2

Condition MeSH

Condition MeSH for Omeprazole And Clarithromycin And Amoxicillin
Intervention	Trials
Helicobacter Infections	13
Communicable Diseases	7
Infections	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
United States	5
Iran, Islamic Republic of	4
Spain	4
Pakistan	3
United Kingdom	3

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
Phase 4	14
Phase 3	8
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Omeprazole And Clarithromycin And Amoxicillin
Clinical Trial Phase	Trials
Completed	23
Unknown status	8
Recruiting	2

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
Tri-Service General Hospital	1
Ayman Magd Eldin Mohammad Sadek	1

Sponsor Type

Sponsor Type for Omeprazole And Clarithromycin And Amoxicillin
Sponsor	Trials
Other	50
Industry	6
NIH	1

Omeprazole, Clarithromycin, and Amoxicillin: Clinical Trials, Market Analysis, and Projections

Introduction

Omeprazole, clarithromycin, and amoxicillin are commonly used in combination for the treatment of Helicobacter pylori (H. pylori) infections, which are associated with peptic ulcers and other gastrointestinal disorders. Here, we will delve into the clinical trials, market analysis, and future projections for this therapeutic combination.

Clinical Trials and Efficacy

Eradication Rates

Clinical trials have consistently shown that the combination of omeprazole, clarithromycin, and amoxicillin is effective in eradicating H. pylori infections. A study by Logan et al. demonstrated an eradication rate of 83% using a regimen of clarithromycin (500 mg three times a day) and omeprazole (40 mg/day) for two weeks, followed by an additional two weeks of omeprazole alone[1].

In another study, a 10-day course of triple therapy with omeprazole, clarithromycin, and amoxicillin achieved an eradication rate of 73%, while a 7-day course resulted in a 50% eradication rate[4].

Dosage and Duration

The efficacy of this combination is influenced by the dosage and duration of treatment. Higher doses of omeprazole (40 mg or more per day) and longer treatment durations (at least 10 days) tend to enhance the eradication rates[1][4].

Adverse Effects

While the combination is generally well-tolerated, adverse effects can occur. Studies have reported that about 3.5% of patients may discontinue the regimen due to adverse events[1].

Mechanism of Action

Omeprazole

Omeprazole is a proton pump inhibitor (PPI) that reduces gastric acid secretion. It achieves its antisecretory effect within one hour of administration, with the maximum effect occurring by two hours. Repeated daily dosing increases the inhibitory effect, reaching a plateau after four days[3].

Clarithromycin and Amoxicillin

Clarithromycin and amoxicillin are antibiotics that target H. pylori bacteria. The combination of these antibiotics with omeprazole enhances their effectiveness by increasing the intragastric concentration of the antibiotics and reducing gastric acid, which helps in achieving the minimal inhibitory concentration (MIC) necessary for bacterial eradication[1].

Market Analysis

Global Market Size and Growth

The global omeprazole market was valued at US$ 2,668.4 million in 2017 and is expected to grow at a compound annual growth rate (CAGR) of 5.2% from 2018 to 2026. This growth is driven by the increasing prevalence of peptic ulcers, gastroesophageal reflux disease (GERD), and H. pylori infections[2].

Regional Market

North America is expected to hold a dominant position in the global omeprazole market due to the high prevalence of H. pylori infections and other gastrointestinal disorders in this region. Attractive pricing policies and discount programs also contribute to the market growth[2].

Key Players and Distribution

The market is influenced by key players in the pharmaceutical industry, and the distribution channels include both retail pharmacies and online platforms. Generic omeprazole, which is covered by most Medicare and insurance plans, further boosts market accessibility[2].

Factors Influencing Market Growth

Increasing Prevalence of Gastrointestinal Disorders

The rising number of patients suffering from GERD, peptic ulcers, and H. pylori infections is a significant driver of the omeprazole market. This is particularly true in developing countries where H. pylori infection is more prevalent[2][5].

Lifestyle and Demographic Factors

Adoption of sedentary lifestyles, an increase in the obese population, and a surge in the geriatric population also contribute to the growth of the omeprazole market[5].

Healthcare Expenditure and R&D Activities

Increased healthcare expenditure and research & development activities by pharmaceutical companies are additional factors propelling the market growth. The launch of novel drugs and the ongoing COVID-19 pandemic, which has highlighted the importance of robust pharmaceutical supply chains, also impact the market positively[5].

Challenges and Alternatives

Resistance and Side Effects

Clarithromycin resistance, which ranges from 5% to 15% in European studies, is a challenge that can reduce the efficacy of the triple therapy regimen[4].

Alternative PPIs

The increasing adoption of alternative PPIs such as pantoprazole, lansoprazole, and esomeprazole can pose a competitive threat to omeprazole. However, omeprazole's established efficacy and favorable pricing policies help it maintain a strong market position[5].

Future Projections

Market Expansion

The omeprazole market is expected to continue growing, driven by the increasing prevalence of gastrointestinal disorders and the ongoing need for effective treatments. The global market is projected to expand further, with North America remaining a key region[2][5].

Innovative Formulations

Future developments may include innovative formulations and combinations that enhance the efficacy and reduce the side effects of the current triple therapy regimen. For instance, the Phase 3 results of Talicia capsules, which combine antibiotics and a PPI, have shown promising outcomes in H. pylori eradication therapy[2].

Key Takeaways

• Efficacy: The combination of omeprazole, clarithromycin, and amoxicillin is highly effective in eradicating H. pylori infections, with eradication rates ranging from 64% to 83% depending on the dosage and duration.
• Market Growth: The global omeprazole market is expected to grow at a CAGR of 5.2% from 2018 to 2026, driven by the increasing prevalence of gastrointestinal disorders and favorable pricing policies.
• Challenges: Clarithromycin resistance and the availability of alternative PPIs are challenges that need to be addressed.
• Future Projections: The market is expected to expand further, with a focus on innovative formulations and combinations to enhance efficacy and reduce side effects.

FAQs

What is the typical dosage for the triple therapy regimen of omeprazole, clarithromycin, and amoxicillin?

The typical dosage involves omeprazole (20-40 mg twice a day), clarithromycin (500 mg three times a day), and amoxicillin (1 g twice a day) for a duration of 7 to 14 days[1][4].

What are the common side effects of this triple therapy regimen?

Common side effects include gastrointestinal disturbances, but serious adverse effects are rare, with about 3.5% of patients discontinuing the regimen due to adverse events[1].

How does omeprazole enhance the efficacy of clarithromycin and amoxicillin?

Omeprazole reduces gastric acid secretion, increasing the intragastric concentration of clarithromycin and amoxicillin, which helps achieve the minimal inhibitory concentration (MIC) necessary for bacterial eradication[1].

What are the key drivers of the omeprazole market growth?

Key drivers include the increasing prevalence of gastrointestinal disorders, adoption of sedentary lifestyles, rise in the obese population, and surge in the geriatric population[2][5].

Are there any alternative treatments to the omeprazole, clarithromycin, and amoxicillin regimen?

Yes, alternative PPIs like pantoprazole, lansoprazole, and esomeprazole are available, but omeprazole remains a preferred option due to its established efficacy and favorable pricing[5].

Sources

1. Treatment of Helicobacter pylori Infection - JAMA Network
2. Omeprazole Market - Coherent Market Insights
3. Omeprazole: Uses, Interactions, Mechanism of Action - DrugBank
4. Triple therapy with clarithromycin, amoxicillin and omeprazole for Helicobacter pylori - SciELO
5. Omeprazole Market Size and Share - Allied Market Research