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.
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 Amoxicillin; Clarithromycin; Omeprazole

Condition Name

Condition Name for Amoxicillin; Clarithromycin; Omeprazole
Intervention	Trials
Helicobacter Pylori Infection	13
Non-alcoholic Fatty Liver Disease	3
Helicobacter Infections	3
Gastritis	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
Iran, Islamic Republic of	4
Spain	4
Pakistan	3
United Kingdom	3

Trials by US State

Trials by US State for Amoxicillin; Clarithromycin; Omeprazole
Location	Trials
Texas	3
Missouri	1
Florida	1

Clinical Trial Progress for Amoxicillin; Clarithromycin; Omeprazole

Clinical Trial Phase

Clinical Trial Phase for Amoxicillin; Clarithromycin; Omeprazole
Clinical Trial Phase	Trials
Phase 4	14
Phase 3	8
Phase 2/Phase 3	1

Clinical Trial Status

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

Clinical Trial Sponsors for Amoxicillin; Clarithromycin; Omeprazole

Sponsor Name

Sponsor Name for Amoxicillin; Clarithromycin; Omeprazole
Sponsor	Trials
Tehran University of Medical Sciences	4
King Faisal Specialist Hospital & Research Center	1
Yokoyama Foundation for Clinical Pharmacology	1

Sponsor Type

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

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

Introduction

Antibiotics and proton pump inhibitors (PPIs) are crucial in the treatment of various bacterial infections and gastrointestinal disorders. This article will delve into the latest clinical trials, market analysis, and projections for amoxicillin, clarithromycin, and omeprazole, three widely used medications in these categories.

Clinical Trials Update

Amoxicillin

Antibiotic-Associated Diarrhea and Gut Health

A recent Phase 4 clinical trial is investigating the effects of amoxicillin on gut nerve and support cells in healthy individuals. This study aims to understand how antibiotics like amoxicillin impact gut health and potentially lead to conditions such as irritable bowel syndrome. The trial involves a screening period of up to 3 weeks, variable treatment duration, and a follow-up period of up to 1 year[3].

Treatment Duration and Dose for Community-Acquired Pneumonia

A randomized clinical trial conducted in low- and middle-income countries has provided evidence supporting shorter treatment durations for amoxicillin in children with community-acquired pneumonia. The study found that a 3-day treatment course was noninferior to a 7-day course, and lower doses (35-50 mg/kg per day) were noninferior to higher doses (70-90 mg/kg per day) in terms of the need for later antibiotic re-treatment[5].

Clarithromycin

Helicobacter pylori Eradication

Clarithromycin, often used in combination with omeprazole, has shown high efficacy in eradicating Helicobacter pylori infections. A study comparing omeprazole plus clarithromycin (OC) to omeprazole plus amoxicillin (OA) found that the OC combination achieved an eradication rate of about 80%, significantly higher than the 50% rate for the OA combination[4].

Omeprazole

H. pylori Eradication and Gastroesophageal Reflux Disease (GERD)

Omeprazole, a PPI, is commonly used to treat GERD and other gastrointestinal disorders. In combination with antibiotics like clarithromycin, omeprazole has been effective in eradicating H. pylori infections. For instance, the Talicia capsule, which combines antibiotics and omeprazole, has shown positive results in Phase 3 trials for H. pylori eradication[2].

Market Analysis

Amoxicillin

Market Size and Usage

Amoxicillin is one of the most widely prescribed antibiotics globally. However, specific market size data for amoxicillin alone is not readily available. It is often used in combination with other medications, such as clavulanate (Augmentin), which has a significant market presence. The increasing resistance to antibiotics and the need for new treatment options are driving research and development in this area[1].

Clarithromycin

Market Integration

Clarithromycin is typically used in combination with other medications, such as omeprazole, for treating H. pylori infections and other gastrointestinal disorders. The market for clarithromycin is closely tied to the broader antibiotic market and the demand for effective treatments against bacterial infections.

Omeprazole

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 CAGR of 5.2% from 2018 to 2026. The increasing prevalence of peptic ulcers, duodenal ulcers, and GERD, along with favorable pricing policies and generic availability, are driving this growth. North America holds a dominant position in the global omeprazole market due to the high incidence of H. pylori infections and other gastrointestinal disorders[2].

Market Projections

Amoxicillin

Future Trends and Challenges

The market for amoxicillin is expected to face challenges due to rising antibiotic resistance. However, ongoing research into new formulations and combinations, such as the study on antibiotic-associated diarrhea, may open new avenues for its use. The need for shorter treatment durations and lower doses, as indicated by recent clinical trials, could also influence market trends[3][5].

Clarithromycin

Continued Demand

The demand for clarithromycin is likely to remain strong due to its efficacy in treating H. pylori infections. As resistance to other antibiotics grows, clarithromycin may see increased usage, particularly in combination therapies. However, the market will need to adapt to evolving treatment guidelines and potential new competitors.

Omeprazole

Growth Drivers

The omeprazole market is expected to continue growing driven by the increasing prevalence of gastrointestinal disorders, favorable pricing policies, and the availability of generic versions. The market will also benefit from ongoing awareness campaigns and educational initiatives by organizations like the International Foundation for Functional Gastrointestinal Disorders (IFFGD)[2].

Key Players and Competitive Landscape

Amoxicillin

Major players in the antibiotic market, including those that produce amoxicillin, include companies like GlaxoSmithKline, Pfizer, and Teva Pharmaceuticals. These companies are focused on developing new formulations and combinations to address antibiotic resistance.

Clarithromycin

Companies like Abbott Laboratories and Teva Pharmaceuticals are key players in the market for clarithromycin. These companies often produce clarithromycin as part of broader antibiotic portfolios.

Omeprazole

The omeprazole market is dominated by companies such as AstraZeneca, Sandoz, Mylan, and Dr. Reddy’s Laboratories. These companies offer both branded and generic versions of omeprazole, contributing to the market's growth[2].

Conclusion

The clinical trials, market analysis, and projections for amoxicillin, clarithromycin, and omeprazole highlight the ongoing importance of these medications in treating bacterial infections and gastrointestinal disorders. While challenges such as antibiotic resistance and evolving treatment guidelines exist, the demand for these drugs is expected to remain strong.

Key Takeaways

• Amoxicillin: Ongoing clinical trials focus on its impact on gut health and optimal treatment durations. The market faces challenges from antibiotic resistance.
• Clarithromycin: High efficacy in H. pylori eradication ensures continued demand, particularly in combination therapies.
• Omeprazole: The market is driven by the increasing prevalence of gastrointestinal disorders and favorable pricing policies.

FAQs

Q1: What is the current status of amoxicillin in clinical trials? A1: Amoxicillin is being studied in a Phase 4 trial to understand its effects on gut health and in a randomized clinical trial to determine optimal treatment durations for community-acquired pneumonia.

Q2: How effective is clarithromycin in treating H. pylori infections? A2: Clarithromycin, when combined with omeprazole, achieves an H. pylori eradication rate of about 80%, significantly higher than other combinations.

Q3: What is the projected growth rate for the omeprazole market? A3: The global omeprazole market is expected to grow at a CAGR of 5.2% from 2018 to 2026.

Q4: Which regions dominate the omeprazole market? A4: North America holds a dominant position in the global omeprazole market due to the high incidence of H. pylori infections and other gastrointestinal disorders.

Q5: What are the key challenges facing the amoxicillin market? A5: The amoxicillin market faces challenges from rising antibiotic resistance, necessitating ongoing research into new formulations and combinations.

References

1. Oral sulopenem shows superiority to amoxicillin/clavulanate for uUTIs. Urology Times.
2. Omeprazole Market - Share, Size and Industry Analysis. Coherent Market Insights.
3. Amoxicillin for Antibiotic-Associated Diarrhea - Clinical Trials. Withpower.
4. Decision analysis of Helicobacter pylori eradication therapy using .... PubMed.
5. Effect of Amoxicillin Dose and Treatment Duration on the Need for .... JAMA Network.