CLINICAL TRIALS PROFILE FOR AMOXIL

All Clinical Trials for Amoxil

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00377403 ↗	Treatment of Acute Sinusitis	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 4	2006-10-01	This study will compare the symptom relief provided by 5 cold medicines versus the symptom relief provided by the same 5 cold medicines plus the antibiotic, amoxicillin, in people who have sinus infections. Treatment with amoxicillin may be more effective than treatment with cold medicines alone. Two hundred adult volunteers, aged 18 to 70 years old, with sinus infections will participate in this study for 28 days. Volunteers will receive a 10-day course of either amoxicillin or placebo (substance containing no medication). In addition, all volunteers will receive pain medication, a chest decongestant, nasal decongestants, and cough medicine as needed. Volunteers will be interviewed by telephone on days 0, 3, 7, 10, and 28 following the start of treatment. The study will look at quality of life factors such as change in functional status (ability to perform daily activities) and symptoms, recurrence of the infection, satisfaction with care, and the direct costs of treatment.
NCT00377403 ↗	Treatment of Acute Sinusitis	Completed	Washington University School of Medicine	Phase 4	2006-10-01	This study will compare the symptom relief provided by 5 cold medicines versus the symptom relief provided by the same 5 cold medicines plus the antibiotic, amoxicillin, in people who have sinus infections. Treatment with amoxicillin may be more effective than treatment with cold medicines alone. Two hundred adult volunteers, aged 18 to 70 years old, with sinus infections will participate in this study for 28 days. Volunteers will receive a 10-day course of either amoxicillin or placebo (substance containing no medication). In addition, all volunteers will receive pain medication, a chest decongestant, nasal decongestants, and cough medicine as needed. Volunteers will be interviewed by telephone on days 0, 3, 7, 10, and 28 following the start of treatment. The study will look at quality of life factors such as change in functional status (ability to perform daily activities) and symptoms, recurrence of the infection, satisfaction with care, and the direct costs of treatment.
NCT00778050 ↗	Bioequivalence Study of Amoxicillin Dispersible 600 mg Tablets Under Fasting Conditions	Completed	Ranbaxy Laboratories Limited	N/A	2002-10-01	This study compared the relative bioavailability (rate and extent of absorption) of amoxicillin tablets for oral suspension 600 mg by Ranbaxy Laboratories Limited with that of Amoxil ® for oral suspension 400 mg/ 5 mL by SmithKline Beecham Pharmaceuticals following single oral dose (600 mg) in healthy, adult, subjects under fasting conditions using a randomized two-way crossover design.
NCT01431989 ↗	Amoxicillin Bioequivalence Study Brazil - Fast	Completed	GlaxoSmithKline	Phase 1	2011-05-27	This study is prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods. The volunteers received, in each period, the reference or the test formulation, according to the randomization list, under fasting conditions, in order to evaluate if the reference and test formulations are bioequivalent.
NCT01530009 ↗	The Effect of Amoxicillin Versus Placebo on Gastrointestinal Motility in Children	Active, not recruiting	Nationwide Children's Hospital	N/A	2012-01-01	The goal of this study is to determine whether amoxicillin (AMX) alone has an appreciable effect on upper gastrointestinal motility compared to placebo. In particular, induction of phase III of the interdigestive migrating motor complex (MMC) by AMX will be the primary outcome of the study. MMCs are periodic waves of electrical activity resulting in muscular contractions that pass through the walls of the stomach and intestinal tract during the fasting state. It is characterized by an initial period where there is a minimal electrical activity and muscular contraction (phase I), followed by a gradual increase in the frequency of contractions (phase III) that often leads to a characteristic cluster of contractions (phase III). This cycle occurs only in the fasting state in normal individuals and the frequency of phase III is quite varied, dependent on age and the presence of any underlying abnormalities in gastrointestinal motility. Secondary outcomes will include characteristics of the MMC, patient demographics in responders and non-responders, and the safety profile of AMX at the intervention dose.
NCT01707485 ↗	Short-course Antimicrobial Therapy for Paediatric Respiratory Infections	Completed	Children's Hospital of Eastern Ontario	Phase 4	2016-09-01	Randomized controlled double-blind non-inferiority clinical trial to determine whether five days of high-dose amoxicillin leads to comparable rates of early clinical cure compared with 10 days of high-dose amoxicillin for previously healthy children with mild community-acquired pneumonia.
NCT01707485 ↗	Short-course Antimicrobial Therapy for Paediatric Respiratory Infections	Completed	Hamilton Health Sciences Corporation	Phase 4	2016-09-01	Randomized controlled double-blind non-inferiority clinical trial to determine whether five days of high-dose amoxicillin leads to comparable rates of early clinical cure compared with 10 days of high-dose amoxicillin for previously healthy children with mild community-acquired pneumonia.

Clinical Trial Conditions for Amoxil

Condition Name

Condition Name for Amoxil
Intervention	Trials
Helicobacter Pylori Infection	3
Community-acquired Pneumonia	3
Acid Dyspepsia	1
Functional Gastrointestinal Disorders	1

Condition MeSH

Condition MeSH for Amoxil
Intervention	Trials
Communicable Diseases	3
Respiratory Tract Infections	3
Pneumonia	3
Infections	3

Clinical Trial Locations for Amoxil

Trials by Country

Trials by Country for Amoxil
Location	Trials
Brazil	5
United States	4
Canada	3
Pakistan	2
Malawi	1

Trials by US State

Trials by US State for Amoxil
Location	Trials
New York	1
Ohio	1
North Dakota	1
Missouri	1

Clinical Trial Progress for Amoxil

Clinical Trial Phase

Clinical Trial Phase for Amoxil
Clinical Trial Phase	Trials
Phase 4	11
Phase 2/Phase 3	3
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Amoxil
Clinical Trial Phase	Trials
Completed	13
Unknown status	2
Withdrawn	2

Clinical Trial Sponsors for Amoxil

Sponsor Name

Sponsor Name for Amoxil
Sponsor	Trials
Hamilton Health Sciences Corporation	2
University of Campinas, Brazil	2
Universidade Estadual Paulista Júlio de Mesquita Filho	2

Sponsor Type

Sponsor Type for Amoxil
Sponsor	Trials
Other	30
Industry	3
NIH	1

Amoxicillin: Clinical Trials, Market Analysis, and Projections

Introduction to Amoxicillin

Amoxicillin, a penicillin-class antibacterial drug, has been a cornerstone in the treatment of various bacterial infections for decades. Its efficacy, safety, and widespread use make it a crucial component in modern healthcare.

Clinical Trials and Efficacy

Phase 1, 2, and 3 Studies

Clinical trials for amoxicillin, particularly for the formulation known as APC-111, have demonstrated its effectiveness. In Phase 1 studies, 112 subjects received the drug, and in Phase 3 studies, 550 patients were treated with APC-111. These studies compared APC-111 to Penicillin VK, showing similar efficacy rates. For example, in one pivotal Phase 3 study, 302 patients received APC-111 once daily for 10 days, achieving a clinical cure rate of 91.4% compared to 92.6% for Penicillin VK[1].

Bacteriological Outcomes

The bacteriological outcomes at the late post-therapy visit were consistent with the results at the test-of-cure (TOC) visit, indicating that amoxicillin is effective in eradicating the causative bacteria. The long history of amoxicillin use and previous FDA findings of its safety and efficacy supported the approval of APC-111 without the need for duplicate Phase 3 studies[1].

Safety Profile

Clinical trials have shown that amoxicillin is generally safe. Serious adverse events were rare and unrelated to the study drug. Common adverse events, such as worsening streptococcal tonsillopharyngitis, headache, and pharyngo-laryngeal pain, were similar in frequency between the amoxicillin and comparator groups. The most common reason for patient discontinuation was pharyngeal pain, which was less common among amoxicillin-treated patients[1].

Market Analysis

Current Market Size and Growth

The global amoxicillin market has seen steady growth in recent years. In 2023, the market size was valued at $4.58 billion and is expected to grow to $4.74 billion in 2024, with a compound annual growth rate (CAGR) of 3.4%. By 2028, the market is projected to reach $5.44 billion, maintaining a CAGR of 3.5%[2].

Drivers of Market Growth

Several factors are driving the growth of the amoxicillin market:

• Increased Understanding of Antibiotics: Enhanced knowledge of antibiotics and their indications has boosted demand.
• Research Activities and Developments: Ongoing research and developments in antibiotic therapy are contributing to market growth.
• Growing Elderly Population: The increasing elderly population, particularly in developed countries, is driving the demand for amoxicillin.
• Rising Prevalence of Infectious Diseases: The growing incidence of lower respiratory infections, skin infections, and urinary tract infections is also a significant driver[2][3].

Market Trends

Key trends shaping the amoxicillin market include:

• Surge in Demand for Generic Amoxicillin: Generic versions of amoxicillin are becoming increasingly popular.
• Focus on Combination Therapies: There is a growing interest in using amoxicillin in combination with other antibiotics or therapies.
• Interest in Probiotics and Immunotherapy: The integration of probiotics and immunotherapy with antibiotic treatments is gaining traction.
• Advancements in Healthcare Facilities: Improvements in healthcare infrastructure are supporting the growth of the amoxicillin market[2][3].

Regional Analysis

Global Market Distribution

The global amoxicillin market is analyzed across various regions:

• Asia-Pacific: This region is witnessing the highest growth due to increasing cases of cardiovascular diseases and a rapidly aging population.
• North America: This region dominates the market due to the high prevalence of respiratory infections and advanced healthcare facilities.
• Europe: Europe is also a significant market, with a share of over 29% of the global market[2][3].

Market Projections

Forecasted Market Size

By 2029, the global amoxicillin market is expected to reach $5.51 billion, growing at a CAGR of 2.0% from 2021. Another forecast indicates that the market will be worth $5,851.7 million by 2030, with a CAGR of 3.4% during the 2024-2030 period[3][5].

Key Players

Major pharmaceutical companies involved in the amoxicillin market include United Laboratories, Sun Pharma, CSPC, LKPC, Hikma Pharmaceuticals USA Inc., Dr. Reddy, HPGC, Aurobindo Pharma, Meiji Holdings, GSK, Novartis, Centrient Pharma, Teva, Mylan, and Cipla[5].

Opportunities and Challenges

Opportunities

• Growing Impaired Renal Function: The increasing number of patients with impaired renal function presents an opportunity for amoxicillin, which is safe for use in such patients.
• Prevalence of Lower Respiratory Infections: The rising cases of lower respiratory infections and other bacterial infections are driving the demand for amoxicillin[3].

Challenges

• Antimicrobial Resistance: The growing concern of antimicrobial resistance poses a significant challenge to the long-term efficacy of amoxicillin.
• Regulatory Frameworks: Continuous updates in regulatory guidelines and post-marketing surveillance for adverse drug reactions are crucial for maintaining market confidence[3].

Key Takeaways

• Efficacy and Safety: Amoxicillin has been proven effective and safe in clinical trials, with a long history of successful use.
• Market Growth: The global amoxicillin market is expected to grow steadily, driven by increased understanding of antibiotics, research activities, and a growing elderly population.
• Regional Trends: Asia-Pacific and North America are key regions driving market growth due to demographic and healthcare factors.
• Market Projections: The market is forecasted to reach $5.51 billion by 2029 and $5,851.7 million by 2030.
• Opportunities and Challenges: Growing impaired renal function and prevalence of infections present opportunities, while antimicrobial resistance and regulatory updates pose challenges.

FAQs

Q: What are the common indications for amoxicillin?

A: Amoxicillin is commonly used to treat infections such as tonsillopharyngitis, respiratory tract infections, skin infections, ear infections, and urinary tract infections[1][3].

Q: What is the safety profile of amoxicillin?

A: Amoxicillin is generally safe, with rare serious adverse events. Common adverse events include worsening streptococcal tonsillopharyngitis, headache, and pharyngo-laryngeal pain[1].

Q: What are the key drivers of the amoxicillin market growth?

A: The growth is driven by increased understanding of antibiotics, research activities, a growing elderly population, and rising prevalence of infectious diseases[2][3].

Q: Which regions are leading the growth in the amoxicillin market?

A: Asia-Pacific and North America are the leading regions, driven by demographic factors and advanced healthcare facilities[2][3].

Q: What is the forecasted market size of the amoxicillin market by 2030?

A: The market is expected to reach $5,851.7 million by 2030, growing at a CAGR of 3.4% from 2024 to 2030[5].

Sources

1. FDA Clinical Pediatric Review: "Amoxicillin Clinical Pediatric Review" - FDA.
2. GlobeNewswire: "Amoxicillin Market Research Report 2024" - GlobeNewswire.
3. Data Bridge Market Research: "Global Amoxicillin Market – Industry Trends and Forecast to 2029" - Data Bridge Market Research.
4. Journal of Infectious Diseases: "Experience with Amoxicillin: An Overall Summary of Clinical Trials in Children and Adults" - Journal of Infectious Diseases.
5. Valuates Reports: "Amoxicillin Antibiotic - Market, Report Size, Worth, Revenue, Growth" - Valuates Reports.

Last updated: 2025-01-01