CLINICAL TRIALS PROFILE FOR METRONIDAZOLE IN PLASTIC CONTAINER

505(b)(2) Clinical Trials for Metronidazole In Plastic Container

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 Formulation	NCT01559545 ↗	A Safety, Tolerability and Pharmacokinetic Study of Two Formulations of Metronidazole Versus Immediate Release Metronidazole in Patient With C. Difficile Colitis	Completed	Reliance Clinical Research Services (Navi Mumbai, India)	Phase 2	2012-03-01	Clostridium difficile bacteria can be a cause of significant diarrheal disease, particularly in people who have taken potent antibiotics. When C. difficile multiplies within the colon, it produces two toxins that cause inflammation and resultant abdominal pain, fever and diarrhea. Current treatment of mild to moderate disease is with immediate release metronidazole, an antibiotic that kills C. difficile. Dr. Reddy's Laboratories has developed a delayed release form of metronidazole to release just before the colon to increase the concentration of antibiotic in the colon to improve the effectiveness of metronidazole treatment and potentially to allow less whole body exposure to the antibiotic. This study will measure the amount of metronidazole in the blood and stool of patients with C. difficile associated diarrhea (CDAD) to confirm that the new formulations are releasing the antibiotic as designed, immediately before the colon.
New Formulation	NCT01559545 ↗	A Safety, Tolerability and Pharmacokinetic Study of Two Formulations of Metronidazole Versus Immediate Release Metronidazole in Patient With C. Difficile Colitis	Completed	Dr. Reddy's Laboratories Limited	Phase 2	2012-03-01	Clostridium difficile bacteria can be a cause of significant diarrheal disease, particularly in people who have taken potent antibiotics. When C. difficile multiplies within the colon, it produces two toxins that cause inflammation and resultant abdominal pain, fever and diarrhea. Current treatment of mild to moderate disease is with immediate release metronidazole, an antibiotic that kills C. difficile. Dr. Reddy's Laboratories has developed a delayed release form of metronidazole to release just before the colon to increase the concentration of antibiotic in the colon to improve the effectiveness of metronidazole treatment and potentially to allow less whole body exposure to the antibiotic. This study will measure the amount of metronidazole in the blood and stool of patients with C. difficile associated diarrhea (CDAD) to confirm that the new formulations are releasing the antibiotic as designed, immediately before the colon.

All Clinical Trials for Metronidazole In Plastic Container

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.
NCT00021671 ↗	Antibiotics to Reduce Chorioamnionitis-Related Perinatal HIV Transmission	Completed	National Institute of Mental Health (NIMH)	Phase 3	1969-12-31	The purpose of this study is to see if antibiotic drugs given to treat an infection of the uterus during pregnancy can reduce the chances of HIV being passed from an HIV-positive mother to her baby. A link between bacterial disease of the vagina, premature birth, infection of the uterus during pregnancy, and the passing of HIV from a mother to her baby has been found. Early treatment of these problems may reduce the risk of passing HIV from an HIV-positive mother to her baby. [Note: As of 02/21/03, enrollment into this study was halted because preliminary data showed that the study antibiotics were not effective in preventing mother-to-child HIV transmission.]

Clinical Trial Conditions for Metronidazole In Plastic Container

Condition Name

Condition Name for Metronidazole In Plastic Container
Intervention	Trials
Helicobacter Pylori Infection	87
Bacterial Vaginosis	43
Periodontitis	13
Chronic Periodontitis	12

Condition MeSH

Condition MeSH for Metronidazole In Plastic Container
Intervention	Trials
Infections	119
Infection	98
Helicobacter Infections	85
Communicable Diseases	80

Clinical Trial Locations for Metronidazole In Plastic Container

Trials by Country

Trials by Country for Metronidazole In Plastic Container
Location	Trials
United States	538
China	78
Taiwan	43
Japan	38
Canada	38

Trials by US State

Trials by US State for Metronidazole In Plastic Container
Location	Trials
California	38
Texas	34
North Carolina	26
Ohio	24
Florida	24

Clinical Trial Progress for Metronidazole In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Metronidazole In Plastic Container
Clinical Trial Phase	Trials
Phase 4	196
Phase 3	92
Phase 2/Phase 3	24

Clinical Trial Status

Clinical Trial Status for Metronidazole In Plastic Container
Clinical Trial Phase	Trials
Completed	268
Unknown status	77
Recruiting	75

Clinical Trial Sponsors for Metronidazole In Plastic Container

Sponsor Name

Sponsor Name for Metronidazole In Plastic Container
Sponsor	Trials
National Taiwan University Hospital	19
Shanghai Jiao Tong University School of Medicine	16
Pfizer	14

Sponsor Type

Sponsor Type for Metronidazole In Plastic Container
Sponsor	Trials
Other	670
Industry	163
NIH	24

Metronidazole in Plastic Containers: Clinical Trials, Market Analysis, and Projections

Introduction

Metronidazole is a synthetic antibacterial compound widely used in various medical applications, including the treatment of bacterial and protozoal infections. When administered intravenously, it is often packaged in plastic containers to ensure sterility and convenience. Here, we delve into the clinical trials, market analysis, and projections for Metronidazole in plastic containers.

Clinical Pharmacology and Safety

Metronidazole is a potent antibacterial agent with a similar disposition in the body whether administered orally or intravenously. The intravenous form is particularly useful in severe infections where oral administration is not feasible. Clinical pharmacology studies have shown that the average elimination half-life of metronidazole in healthy humans is approximately eight hours[1][3][4].

Safety of Plastic Containers

The safety of the plastic containers used for metronidazole injections has been rigorously tested. These containers are made from a specially formulated non-plasticized, thermoplastic copolyolephine and have passed Class VI testing as specified in the U.S. Pharmacopeia for Biological Tests – Plastic Containers. Although solutions in contact with the container can leach out small amounts of chemical components like di-2-ethylhexyl phthalate (DEHP), these amounts are within safe limits and do not significantly affect the solution's efficacy or safety[1][3][4].

Clinical Trials and Efficacy

Clinical trials have consistently shown that metronidazole is effective in treating a range of infections, including those caused by anaerobic bacteria and protozoa. For intravenous administration, a typical dosage regimen involves a loading dose followed by maintenance doses, with plasma concentrations of metronidazole being proportional to the administered dose[3].

Carcinogenicity and Precautions

While metronidazole has been shown to be carcinogenic in mice and rats, its use in humans is generally safe when reserved for indicated conditions. Unnecessary use should be avoided to maintain the effectiveness of the drug and prevent the development of drug-resistant bacteria[3].

Market Analysis

The metronidazole market is diverse and global, with various forms of the drug available, including tablets, capsules, injections, and creams/gels.

Market Segmentation

• By Consumption: The market is segmented into different forms such as tablets, capsules, injections, and creams/gels. The injection form, particularly in plastic containers, is significant in hospital settings for severe infections[2][5].
• By Usage: Metronidazole is used primarily in humans but also in specific animals. The human segment dominates the market due to the drug's widespread use in treating various infections[2][5].
• By Distribution Channel: The drug is distributed through hospital pharmacies, retail pharmacies, and online retail channels. Hospital pharmacies are a major distribution channel for intravenous metronidazole due to its use in critical care settings[2][5].

Geographic Analysis

The metronidazole market is analyzed across major geographic regions including North America, Europe, Asia Pacific, Middle East and Africa, and Latin America. Each region has its own market dynamics, with North America and Europe being significant markets due to advanced healthcare infrastructure and high demand for antibacterial drugs[2][5].

Key Players

The market includes key players such as Hongyuan Pharmaceutical, Yinhe Aarti Pharmaceutical, Aarti Drugs, Yichang Changjiang Pharmaceutical, and others. These companies are focusing on expanding their product portfolios and business in the global market[2][5].

Market Trends and Projections

Market Size and Growth

The global metronidazole market has been growing steadily, driven by increasing demand for effective antibacterial treatments. The market size is expected to continue growing, with a significant compound annual growth rate (CAGR) projected from 2024 to 2031[5].

Opportunities and Challenges

• Opportunities: The decline in raw material prices has increased production, and the growing need for antibacterial drugs in emerging markets presents significant opportunities for growth[2][5].
• Challenges: The market faces challenges such as the development of drug-resistant bacteria and the need for continuous innovation to stay ahead of bacterial resistance[2][5].

Regional Insights

• North America: This region is expected to remain a major market due to its advanced healthcare system and high demand for metronidazole.
• Asia Pacific: This region is projected to experience significant growth due to increasing healthcare expenditure and a large patient population[5].

Key Takeaways

• Clinical Efficacy: Metronidazole in plastic containers is a clinically effective treatment for various bacterial and protozoal infections.
• Safety: The plastic containers used have been tested for safety and comply with USP biological tests.
• Market Growth: The global metronidazole market is expected to grow significantly, driven by increasing demand and declining raw material costs.
• Geographic Focus: North America and Asia Pacific are key regions for market growth.

FAQs

What is the typical dosage regimen for intravenous metronidazole?

The typical dosage regimen involves a loading dose followed by maintenance doses, with plasma concentrations proportional to the administered dose[3].

Are the plastic containers used for metronidazole injections safe?

Yes, the plastic containers have been tested and confirmed safe by biological evaluation procedures and comply with USP biological tests for plastic containers[1][3][4].

Which regions are expected to drive the growth of the metronidazole market?

North America and Asia Pacific are expected to be significant drivers of market growth due to their healthcare infrastructure and growing demand for antibacterial drugs[5].

What are the main distribution channels for metronidazole?

The main distribution channels include hospital pharmacies, retail pharmacies, and online retail channels[2][5].

What are the potential challenges facing the metronidazole market?

The development of drug-resistant bacteria and the need for continuous innovation are significant challenges facing the market[2][5].

Sources

1. DailyMed - Metronidazole Injection, USP
2. IndustryARC - Metronidazole Market - Forecast(2017-2025) Research Report
3. FDA - Metronidazole Injection, USP - accessdata.fda.gov
4. FDA - 100 mL (5 mg/mL) Sterile - accessdata.fda.gov
5. Cognitive Market Research - Metronidazole Market Report 2025 (Global Edition)

Last updated: 2025-01-06