CLINICAL TRIALS PROFILE FOR IOPAMIDOL-200 IN PLASTIC CONTAINER

All Clinical Trials for Iopamidol-200 In Plastic Container

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	ABX CRO	Phase 4	2005-06-01	It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	ABX-CRO	Phase 4	2005-06-01	It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	Averion International Corporation	Phase 4	2005-06-01	It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	Covance	Phase 4	2005-06-01	It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.

Clinical Trial Conditions for Iopamidol-200 In Plastic Container

Condition Name

Condition Name for Iopamidol-200 In Plastic Container
Intervention	Trials
Coronary Artery Stenosis	3
Diabetes Mellitus	2
Coronary Artery Disease	2
Percutaneous Coronary Intervention	1

Condition MeSH

Condition MeSH for Iopamidol-200 In Plastic Container
Intervention	Trials
Renal Insufficiency	6
Renal Insufficiency, Chronic	3
Diabetes Mellitus	3
Kidney Diseases	3

Clinical Trial Locations for Iopamidol-200 In Plastic Container

Trials by Country

Trials by Country for Iopamidol-200 In Plastic Container
Location	Trials
United States	20
Italy	2
China	2
Canada	2
Singapore	1

Trials by US State

Trials by US State for Iopamidol-200 In Plastic Container
Location	Trials
New Jersey	10
California	2
North Carolina	2
Illinois	2
Texas	1

Clinical Trial Progress for Iopamidol-200 In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Iopamidol-200 In Plastic Container
Clinical Trial Phase	Trials
Phase 4	16
Phase 2/Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for Iopamidol-200 In Plastic Container
Clinical Trial Phase	Trials
Completed	15
Terminated	5
Recruiting	5

Clinical Trial Sponsors for Iopamidol-200 In Plastic Container

Sponsor Name

Sponsor Name for Iopamidol-200 In Plastic Container
Sponsor	Trials
Bracco Diagnostics, Inc	8
GE Healthcare	6
i3 Statprobe	3

Sponsor Type

Sponsor Type for Iopamidol-200 In Plastic Container
Sponsor	Trials
Industry	27
Other	22
NIH	2

Iopamidol-200: Clinical Trials, Market Analysis, and Projections

Introduction

Iopamidol, a non-ionic radiographic contrast agent, is widely used in various medical imaging procedures. The ISOVUE-200 formulation, specifically, is a 41% w/v solution of iopamidol, utilized for several diagnostic purposes. Here, we will delve into the clinical trials, market analysis, and future projections for Iopamidol-200.

Clinical Trials and Safety Profile

Clinical Studies

Clinical trials involving ISOVUE-200 (iopamidol injection 41%) have demonstrated its efficacy and safety in various radiological procedures. These studies have shown that intravascular administration of iopamidol results in significant but transient changes in vital signs and hemodynamic parameters, which are generally smaller compared to conventional ionic contrast media[1][4].

Adverse Reactions

The adverse reaction profile of ISOVUE-200 is well-documented. Clinical studies in about 686 patients have identified common adverse reactions, which include mild to moderate effects such as nausea, vomiting, and headache. Serious reactions are rare but can include hypersensitivity reactions and cardiovascular events[4].

Pharmacokinetics

The pharmacokinetics of iopamidol conform to an open two-compartment model with first-order elimination. The drug is rapidly distributed and then slowly eliminated, with an elimination half-life of approximately two hours. Iopamidol is primarily excreted unchanged through the kidneys, with minimal metabolism or biotransformation[1][4].

Market Analysis

Market Presence

ISOVUE-200, marketed by Bracco Imaging Canada among other companies, has been available since 1998. It is a prescription-only drug and is widely used in hospitals and diagnostic imaging centers for various procedures such as peripheral venography, cerebral arteriography, and computed tomography (CT) scans[5].

Market Trends

The market for contrast agents is evolving, with a focus on safety, efficacy, and innovative packaging solutions. Recent trends include the use of bulk, multi-dose containers and polymer containers, which enhance convenience and reduce waste[3].

Competitive Landscape

Iopamidol competes with other non-ionic contrast agents in the market. However, its stability, aqueous formulation, and nonpyrogenic nature make it a preferred choice for many radiological procedures. The brand's long-standing presence and wide range of formulations (ISOVUE-200, ISOVUE-300, ISOVUE-370) contribute to its market share[2][4].

Indications and Usage

Intravascular Procedures

ISOVUE-200 is indicated for peripheral venography (phlebography) in adults. It is also used for intravenous contrast enhancement in CT scans of the head or body in both adults and children[1][4].

Myelography

Although ISOVUE-200 is not recommended for intrathecal use, other formulations of iopamidol are used for myelography, including lumbar, thoracic, and cervical myelography[2][4].

Contraindications and Precautions

Contraindications

ISOVUE-200 is contraindicated in patients with known hypersensitivity to the product and in those with significant impairment of both renal and hepatic functions. Immediate repeat myelography in the event of technical failure is also contraindicated[1][4].

Precautions

Special precautions are necessary for patients with renal impairment, as the elimination half-life of iopamidol is prolonged in such cases. Elderly patients and those with myelomatous conditions require careful evaluation and monitoring[1][4].

Future Projections

Market Growth

The demand for contrast agents is expected to grow due to the increasing need for diagnostic imaging procedures. Advances in medical imaging technologies, such as improved CT scans and MRI, will continue to drive the market for contrast agents like iopamidol[3].

Innovations

Future innovations in contrast agent packaging and delivery systems are likely to enhance the convenience and safety of iopamidol administration. This could include more sustainable packaging options and improved dosing systems[3].

Regulatory Environment

Regulatory updates and guidelines will continue to shape the market for iopamidol. Manufacturers must adhere to stringent safety and efficacy standards, ensuring that products like ISOVUE-200 remain compliant with evolving regulatory requirements[4].

Key Takeaways

• Clinical Trials: ISOVUE-200 has been extensively studied, showing a favorable safety profile with transient and generally mild adverse effects.
• Market Presence: Widely used since 1998, ISOVUE-200 is a staple in diagnostic imaging.
• Indications: Used for peripheral venography and CT scans, among other procedures.
• Contraindications: Avoid use in patients with hypersensitivity or significant renal and hepatic impairment.
• Future Projections: Expected market growth driven by advances in medical imaging and innovations in packaging and delivery.

FAQs

What is the primary use of ISOVUE-200?

ISOVUE-200 is primarily used for peripheral venography (phlebography) in adults and for intravenous contrast enhancement in computed tomography (CT) scans of the head or body in both adults and children.

What are the common adverse reactions associated with ISOVUE-200?

Common adverse reactions include nausea, vomiting, and headache. Serious reactions can include hypersensitivity reactions and cardiovascular events.

How is iopamidol excreted from the body?

Iopamidol is primarily excreted unchanged through the kidneys by glomerular filtration, with a small portion excreted through the liver in cases of renal impairment.

Can ISOVUE-200 be used in patients with renal impairment?

While ISOVUE-200 can be used in patients with renal impairment, special precautions are necessary, including close monitoring and maintenance of normal hydration.

What are the contraindications for ISOVUE-200?

ISOVUE-200 is contraindicated in patients with known hypersensitivity to the product and in those with significant impairment of both renal and hepatic functions.

Sources

1. IsovueTM Iopamidol Injection USP (41%, 61%, and 76% w/v) NON ... - Bracco, 2017.
2. Iopamidol | Drug Information, Uses, Side Effects, Chemistry - PharmaCompass.
3. Recent Trends and Developments in Contrast Media - IT Nonline, 2017.
4. ISOVUE® (Iopamidol Injection) - FDA, 2012.
5. Details for: ISOVUE 200 INJECTION - Health Products Portal, Government of Canada.