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Last Updated: February 11, 2025

CLINICAL TRIALS PROFILE FOR FLAGYL I.V. RTU IN PLASTIC CONTAINER


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505(b)(2) Clinical Trials for Flagyl I.v. Rtu 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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Flagyl I.v. Rtu In Plastic Container

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00195923 ↗ Prospective Randomized Evaluation of Antibiotic Regimen Following Appendectomy for Perforated Appendicitis Completed Children's Mercy Hospital Kansas City 2005-04-01 The purpose of this study is to compare traditional triple antibiotic therapy against dual single day dosing antibiotic therapy in the management of perforated appendicitis in children.
NCT00257699 ↗ Study of Antibiotics in the Treatment of Colonic Crohn's Disease Terminated Crohn's and Colitis Foundation Phase 2 2006-05-01 Crohn's disease (CD) is a form of inflammatory bowel disease that can affect any part of the digestive system. Symptoms of this chronic illness include abdominal pain, bloating, nausea, vomiting, and diarrhea. CD also causes bowel wall ulcers, strictures (narrowings of a hollow structure due to scar tissue and swelling), and fistulae (abnormal passages from the intestines to another organ or to the skin). CD is thought to arise from a combination of inherited (genetic) factors and some undefined environmental factor(s). One environmental factor that has been shown to be intimately involved with the development of CD is the presence of bacteria that normally inhabit the intestines. As a result, some physicians have tried to alter the normal bacterial population as a means of controlling the inflammation (swelling) in the intestines of individuals with CD. Among such strategies is the use of a combination of metronidazole and ciprofloxacin. These broad-spectrum antibiotics control CD symptoms by acting on the intestinal bacteria that can contribute to chronic inflammation. More investigation is needed to firmly establish the usefulness of this therapy because previous clinical trials have given mixed results, although they have suggested that antibiotics can be particularly useful in cases of Crohn's colitis (CD that primarily affects the large intestine). Because these earlier studies have lacked a large enough patient population with colonic involvement, a trial focusing on this CD subgroup with a sufficient number of subjects will help to clarify the value of combining metronidazole and ciprofloxacin. The proposed study will test the hypothesis that combination antibiotic therapy is effective in the treatment of CD involving the colon. The study will compare the use of combination therapy consisting of metronidazole and ciprofloxacin with placebo (dummy tablets) and will examine the results of treatment at the end of 8 weeks of treatment.
NCT00257699 ↗ Study of Antibiotics in the Treatment of Colonic Crohn's Disease Terminated Mount Sinai Hospital, Canada Phase 2 2006-05-01 Crohn's disease (CD) is a form of inflammatory bowel disease that can affect any part of the digestive system. Symptoms of this chronic illness include abdominal pain, bloating, nausea, vomiting, and diarrhea. CD also causes bowel wall ulcers, strictures (narrowings of a hollow structure due to scar tissue and swelling), and fistulae (abnormal passages from the intestines to another organ or to the skin). CD is thought to arise from a combination of inherited (genetic) factors and some undefined environmental factor(s). One environmental factor that has been shown to be intimately involved with the development of CD is the presence of bacteria that normally inhabit the intestines. As a result, some physicians have tried to alter the normal bacterial population as a means of controlling the inflammation (swelling) in the intestines of individuals with CD. Among such strategies is the use of a combination of metronidazole and ciprofloxacin. These broad-spectrum antibiotics control CD symptoms by acting on the intestinal bacteria that can contribute to chronic inflammation. More investigation is needed to firmly establish the usefulness of this therapy because previous clinical trials have given mixed results, although they have suggested that antibiotics can be particularly useful in cases of Crohn's colitis (CD that primarily affects the large intestine). Because these earlier studies have lacked a large enough patient population with colonic involvement, a trial focusing on this CD subgroup with a sufficient number of subjects will help to clarify the value of combining metronidazole and ciprofloxacin. The proposed study will test the hypothesis that combination antibiotic therapy is effective in the treatment of CD involving the colon. The study will compare the use of combination therapy consisting of metronidazole and ciprofloxacin with placebo (dummy tablets) and will examine the results of treatment at the end of 8 weeks of treatment.
NCT00353743 ↗ The Use of Antibiotics After Hospital Discharge in Septic Abortion Terminated Hospital de Clinicas de Porto Alegre N/A 2006-05-01 The use of antibiotics in post-partum infection has been abbreviated. After 48 hours of clinical improvement, the patient is discharged from the hospital without antibiotics. No trials has been found in cases of septic abortion. The purpose of the present study is to verify the need of antibiotics after clinical improvement in cases of septic abortion.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Flagyl I.v. Rtu In Plastic Container

Condition Name

Condition Name for Flagyl I.v. Rtu In Plastic Container
Intervention Trials
Helicobacter Pylori Infection 11
Bacterial Vaginosis 6
Crohn's Disease 3
Vaginal Discharge 2
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Condition MeSH

Condition MeSH for Flagyl I.v. Rtu In Plastic Container
Intervention Trials
Infections 10
Infection 10
Communicable Diseases 8
Helicobacter Infections 8
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Clinical Trial Locations for Flagyl I.v. Rtu In Plastic Container

Trials by Country

Trials by Country for Flagyl I.v. Rtu In Plastic Container
Location Trials
United States 38
Taiwan 10
India 7
Canada 6
Brazil 6
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Trials by US State

Trials by US State for Flagyl I.v. Rtu In Plastic Container
Location Trials
Pennsylvania 4
Michigan 3
North Carolina 3
California 3
Texas 3
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Clinical Trial Progress for Flagyl I.v. Rtu In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Flagyl I.v. Rtu In Plastic Container
Clinical Trial Phase Trials
Phase 4 26
Phase 3 10
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Flagyl I.v. Rtu In Plastic Container
Clinical Trial Phase Trials
Completed 36
Unknown status 15
Recruiting 10
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Clinical Trial Sponsors for Flagyl I.v. Rtu In Plastic Container

Sponsor Name

Sponsor Name for Flagyl I.v. Rtu In Plastic Container
Sponsor Trials
National Taiwan University Hospital 4
Chang Gung Memorial Hospital 4
National Institute of Allergy and Infectious Diseases (NIAID) 3
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Sponsor Type

Sponsor Type for Flagyl I.v. Rtu In Plastic Container
Sponsor Trials
Other 99
Industry 19
NIH 5
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FLAGYL I.V. RTU IN PLASTIC CONTAINER: Clinical Trials, Market Analysis, and Projections

Introduction

FLAGYL I.V. RTU (Ready-to-Use) in plastic containers is a formulation of the antibiotic metronidazole, used to treat various serious bacterial infections. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Uses and Indications

FLAGYL I.V. RTU is utilized to treat a range of bacterial infections, including intra-abdominal infections, skin and skin structure infections, and gynecologic infections. It is effective against bacteria such as Bacteroides fragilis and other anaerobic bacteria that are resistant to other antibiotics like clindamycin, chloramphenicol, and penicillin[4].

Clinical Trials and Safety Profile

Clinical trials for metronidazole injection have primarily focused on its efficacy and safety in treating bacterial infections. While there have been no specific recent clinical trials solely dedicated to FLAGYL I.V. RTU, existing data from previous studies indicate its effectiveness. However, it is important to note that metronidazole has been shown to be carcinogenic in mice and rats, and its use should be reserved for approved conditions only[1][4].

Safety Concerns

  • Metronidazole is contraindicated in patients with a prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives.
  • It can cause convulsive seizures and peripheral neuropathy.
  • There are no adequate and well-controlled studies in pregnant women, and it should be used during pregnancy only if clearly needed[4].

Market Analysis

The market for FLAGYL I.V. RTU is part of the broader antibiotic market, which is influenced by several factors.

Market Size and Growth

The antibiotic market, including intravenous antibiotics like FLAGYL I.V. RTU, is significant and growing due to the increasing incidence of bacterial infections and the need for effective treatments. However, specific market size data for FLAGYL I.V. RTU is not readily available.

Competitive Landscape

FLAGYL I.V. RTU competes with other intravenous antibiotics such as ciprofloxacin, doxycycline, and azithromycin. The competitive landscape is driven by factors such as efficacy, safety profile, and cost-effectiveness[1].

Packaging and Delivery

The packaging of FLAGYL I.V. RTU in plastic containers, specifically the VIAFLEX Plus container, has undergone enhancements to improve product differentiation, label readability, and reduce medication errors. This is part of a broader trend in the clinical trial packaging market, where ease of use, patient safety, and compliance with regulations are key drivers[2][3].

Market Projections

Growth Drivers

  • Increasing Demand for Efficient Treatments: The need for effective and safe treatments for bacterial infections continues to drive the demand for antibiotics like FLAGYL I.V. RTU.
  • Advancements in Clinical Trials: The integration of new technologies and innovative packaging solutions is expected to enhance the market growth[3].

Challenges

  • Regulatory Compliance: Strict regulations and the need for compliance can increase production costs and hinder market growth.
  • Production Costs: Advanced manufacturing techniques and high-quality packaging materials contribute to higher production costs, which can be a barrier to market expansion[3].

Regional Insights

  • North America: This region dominates the clinical trial packaging market, including the segment for intravenous antibiotics, due to its well-developed infrastructure and strong supply chain network[3].

Future Outlook

The future outlook for FLAGYL I.V. RTU is positive, driven by the ongoing need for effective treatments for bacterial infections and advancements in packaging and delivery systems.

Emerging Trends

  • Integration of Digital Technology: The use of digital technologies in clinical trials and packaging is expected to improve efficiency and patient safety.
  • Customized Packaging: Offering customized packaging solutions can create new opportunities for market growth[3].

Potential Opportunities

  • Increasing Clinical Investments: Investments in research and development for clinical trials are expected to create opportunities for the growth of the antibiotic market.
  • Emerging Markets: Expanding into emerging markets with growing healthcare needs can provide additional growth opportunities for FLAGYL I.V. RTU[3].

Key Takeaways

  • Effective Treatment: FLAGYL I.V. RTU is an effective treatment for various serious bacterial infections.
  • Safety Profile: It has a known safety profile with specific contraindications and potential side effects.
  • Market Growth: The market is driven by the need for efficient treatments and advancements in clinical trials and packaging.
  • Challenges: Regulatory compliance and production costs are significant challenges.
  • Future Outlook: The integration of digital technology and customized packaging solutions are expected to drive future growth.

FAQs

What is FLAGYL I.V. RTU used for?

FLAGYL I.V. RTU is used to treat serious bacterial infections, including intra-abdominal infections, skin and skin structure infections, and gynecologic infections.

What are the potential side effects of FLAGYL I.V. RTU?

Potential side effects include dry mouth, hives or welts, skin rash, stomach discomfort, stuffy nose, and an unpleasant metallic taste[1].

Is FLAGYL I.V. RTU safe for pregnant women?

FLAGYL I.V. RTU should be used during pregnancy only if clearly needed, as it has been shown to be carcinogenic in animal studies and there are no adequate and well-controlled studies in pregnant women[4].

How is FLAGYL I.V. RTU administered?

It is administered intravenously through a needle placed into a vein, typically in a hospital setting under the supervision of a healthcare professional[1].

What are the packaging enhancements for FLAGYL I.V. RTU?

The packaging has been enhanced to improve product differentiation, label readability, and reduce medication errors, using containers like the VIAFLEX Plus[2].

What are the growth drivers for the FLAGYL I.V. RTU market?

Growth drivers include the increasing demand for efficient treatments, advancements in clinical trials, and the integration of new technologies in packaging[3].

Sources

  1. Drugs.com: Flagyl I.V. RTU Advanced Patient Information.
  2. FDA: Flagyl I.V. (metronidazole injection, USP), RTU in Viaflex Plus Container.
  3. GlobeNewswire: Clinical Trial Packaging Market Size Expected to Reach USD 9.12 Billion by 2034.
  4. FDA: Metronidazole Injection, USP RTU® in Plastic Container VIAFLEX Plus Container.

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