CLINICAL TRIALS PROFILE FOR OMNIPAQUE 180

All Clinical Trials for Omnipaque 180

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00478556 ↗	Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT	Completed	GE Healthcare	Phase 4	2007-08-01	Patients who are scheduled by their health care provider for routine computed tomography (CT) scan will be asked to participate in this study. The primary purpose is to determine if there is a difference in patient preference for Omnipaque versus Gastroview as oral contrast for abdominal pelvic CT. A secondary objective is to evaluate if there is significant difference in bowel opacification for the two agents.
NCT00478556 ↗	Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT	Completed	University of Alabama at Birmingham	Phase 4	2007-08-01	Patients who are scheduled by their health care provider for routine computed tomography (CT) scan will be asked to participate in this study. The primary purpose is to determine if there is a difference in patient preference for Omnipaque versus Gastroview as oral contrast for abdominal pelvic CT. A secondary objective is to evaluate if there is significant difference in bowel opacification for the two agents.
NCT00587132 ↗	Secretin (ChiRhoStim) Pancreas Perfusion for Pancreatic Adenocarcinoma	Terminated	ChiRhoClin, Inc.	Phase 1/Phase 2	2006-11-01	The purpose of this study is to test if secretin-enhanced CT is a useful noninvasive screening tool for pancreatic cancer in a high-risk population.
NCT00587132 ↗	Secretin (ChiRhoStim) Pancreas Perfusion for Pancreatic Adenocarcinoma	Terminated	Mayo Clinic	Phase 1/Phase 2	2006-11-01	The purpose of this study is to test if secretin-enhanced CT is a useful noninvasive screening tool for pancreatic cancer in a high-risk population.
NCT00857792 ↗	Multivariable Assessment of Coronary Artery Disease Using Cardiac CT Imaging	Completed	Astellas Pharma Inc	N/A	2009-03-01	The investigators goals are: 1. to develop software for quantitative volumetric analysis of myocardial perfusion from MDCT images 2. to test its ability to accurately determine the presence, location, extend and severity of perfusion abnormalities in agreement with conventional diagnostic techniques (ICA and MPI) in patients with normal and abnormal coronary arteries and/or perfusion patterns 3. to test this approach in patients undergoing vasodilator stress tests with MDCT imaging in combination with the new vasodilator stress agent Regadenoson.
NCT00857792 ↗	Multivariable Assessment of Coronary Artery Disease Using Cardiac CT Imaging	Completed	University of Chicago	N/A	2009-03-01	The investigators goals are: 1. to develop software for quantitative volumetric analysis of myocardial perfusion from MDCT images 2. to test its ability to accurately determine the presence, location, extend and severity of perfusion abnormalities in agreement with conventional diagnostic techniques (ICA and MPI) in patients with normal and abnormal coronary arteries and/or perfusion patterns 3. to test this approach in patients undergoing vasodilator stress tests with MDCT imaging in combination with the new vasodilator stress agent Regadenoson.
NCT00938561 ↗	Evaluation of New Markers to Assess Kidney Function	Withdrawn	Dialysis Clinic, Inc.		2009-09-01	Glomerular filtration rate (GFR) is widely accepted as the best index of kidney function in health and disease, and accurate values are required for optimal clinical decision making and in large-scale epidemiologic studies and clinical trials. Current recommended methods for measuring GFR are expensive, cumbersome to administer and assay and requires urine collection and administration of radioactive materials. The purpose of this study is to evaluate two non-radioactive markers (iohexol and gadolinium) compared to urinary clearance of inulin and iothalamate. The investigators hypothesize that plasma clearance of non-radioactive markers will be unbiased compared to a gold standard and more precise than currently used urinary clearance methods.

Clinical Trial Conditions for Omnipaque 180

Condition Name

Condition Name for Omnipaque 180
Intervention	Trials
Malignant Solid Neoplasm	1
Contrast Induced Nephropathy	1
Hypothyroidism	1
Acute Kidney Injury	1

Condition MeSH

Condition MeSH for Omnipaque 180
Intervention	Trials
Coronary Artery Disease	3
Myocardial Ischemia	2
Renal Insufficiency	2
Acquired Immunodeficiency Syndrome	1

Clinical Trial Locations for Omnipaque 180

Trials by Country

Trials by Country for Omnipaque 180
Location	Trials
United States	48
France	2
Korea, Republic of	1
Canada	1
Colombia	1

Trials by US State

Trials by US State for Omnipaque 180
Location	Trials
California	4
Pennsylvania	3
Minnesota	3
Ohio	2
Maryland	2

Clinical Trial Progress for Omnipaque 180

Clinical Trial Phase

Clinical Trial Phase for Omnipaque 180
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Omnipaque 180
Clinical Trial Phase	Trials
Completed	8
Recruiting	7
Not yet recruiting	6

Clinical Trial Sponsors for Omnipaque 180

Sponsor Name

Sponsor Name for Omnipaque 180
Sponsor	Trials
National Cancer Institute (NCI)	2
GE Healthcare	2
University of California, San Diego	2

Sponsor Type

Sponsor Type for Omnipaque 180
Sponsor	Trials
Other	32
Industry	12
NIH	4

OMNIPAQUE 180: Clinical Trials, Market Analysis, and Projections

Introduction

OMNIPAQUE 180, a formulation of the iodinated contrast agent iohexol, is widely used in various medical imaging procedures. This article will delve into the clinical trials that have supported its use, analyze its market position, and provide projections for its future in the medical imaging sector.

Clinical Trials Overview

Adult Indications

The use of OMNIPAQUE 180 in adults has been supported by several clinical trials. For radiographic imaging of the gastrointestinal (GI) tract, trials such as N-137 and PS-632 demonstrated the safety, tolerability, and efficacy of OMNIPAQUE 350, with extrapolated data supporting the use of OMNIPAQUE 300 for this indication as well[1].

In the context of CT scans of the abdomen and pelvis, Study PS-641 evaluated the concomitant use of oral and intravenous OMNIPAQUE. This study showed that OMNIPAQUE had fewer adverse events compared to the active control gastrografin 282 and produced images of comparable diagnostic quality[1].

Pediatric Indications

For pediatric patients, OMNIPAQUE 180 has been studied in various trials. Study IOH-1058, which included adolescent patients, demonstrated comparable efficacy and safety between OMNIPAQUE 300 and the active control barium sulfate for GI tract imaging[1].

Another study, IOH-1030, an open-label, non-comparative trial, involved 70 pediatric patients requiring contrast-enhanced CT of the abdomen. This study confirmed the safety and efficacy of age-appropriate diluted oral dosing of OMNIPAQUE in conjunction with intravenous administration[1].

Safety and Adverse Reactions

Clinical trials and post-marketing data have highlighted several safety considerations for OMNIPAQUE 180. Common adverse reactions in adults include headaches, pain, nausea, vomiting, and dizziness, particularly after intrathecal administration[2][4].

In pediatric patients, adverse events such as headache, vomiting, and backache have been reported, though at a lower frequency compared to adults. Serious reactions, including contrast-induced acute kidney injury and cardiovascular adverse reactions, can occur and necessitate careful patient monitoring and hydration[2][4].

Market Analysis

Current Market Status

OMNIPAQUE 180 is part of a broader portfolio of iohexol formulations offered by GE Healthcare. The drug is indicated for various routes of administration, including intravascular, oral, rectal, intraarticular, and body cavity administration, making it a versatile option in medical imaging[2].

Market Trends

The demand for contrast agents like OMNIPAQUE 180 is driven by the increasing need for diagnostic imaging procedures. Advances in CT and MRI technologies, along with an aging population and rising incidence of chronic diseases, are expected to sustain market growth.

However, the market is also subject to challenges such as drug shortages. For instance, a recent shortage of OMNIPAQUE 180 in Canada was reported and subsequently resolved[5].

Competitive Landscape

The market for iodinated contrast agents is competitive, with other products like gastrografin and barium sulfate also being used. OMNIPAQUE 180 differentiates itself through its broad range of indications and favorable safety profile compared to some competitors[1][2].

Projections and Future Outlook

Market Growth

The global contrast agents market is projected to grow significantly over the next few years, driven by technological advancements and increasing healthcare expenditures. OMNIPAQUE 180, with its established safety and efficacy profile, is likely to remain a key player in this market.

Emerging Trends

The integration of artificial intelligence and machine learning in medical imaging is expected to enhance the diagnostic capabilities of contrast agents like OMNIPAQUE 180. Additionally, ongoing research into new formulations and administration routes may further expand its indications and improve patient outcomes.

Regulatory Considerations

Regulatory approvals and updates will continue to play a crucial role in the market trajectory of OMNIPAQUE 180. Recent approvals for new routes of administration and indications, as seen in the Supplemental New Drug Submission, highlight the ongoing efforts to expand its clinical utility[1].

Key Takeaways

• Clinical Trials: OMNIPAQUE 180 has been supported by multiple clinical trials demonstrating its safety, tolerability, and efficacy in both adult and pediatric populations.
• Safety Profile: While generally safe, OMNIPAQUE 180 can cause adverse reactions, and careful patient monitoring is necessary.
• Market Analysis: The drug is part of a competitive market but maintains a strong position due to its broad indications and favorable safety profile.
• Projections: The market for contrast agents is expected to grow, driven by technological advancements and increasing healthcare needs.

FAQs

What are the common indications for OMNIPAQUE 180?

OMNIPAQUE 180 is indicated for various medical imaging procedures, including radiographic imaging of the GI tract, CT scans of the abdomen and pelvis, and intrathecal administration for myelography and other procedures[1][2].

What are the potential adverse reactions associated with OMNIPAQUE 180?

Common adverse reactions include headaches, pain, nausea, vomiting, and dizziness. Serious reactions such as contrast-induced acute kidney injury and cardiovascular adverse reactions can also occur[2][4].

How does OMNIPAQUE 180 compare to other contrast agents?

OMNIPAQUE 180 has a favorable safety profile compared to some competitors and offers a broad range of indications, making it a versatile option in medical imaging[1][2].

What are the recent regulatory updates for OMNIPAQUE 180?

Recent regulatory updates include approvals for new routes of administration and indications, such as oral administration for GI tract imaging and CT scans of the abdomen and pelvis[1].

What are the market trends affecting OMNIPAQUE 180?

The market is driven by increasing demand for diagnostic imaging, technological advancements, and an aging population. However, it is also subject to challenges like drug shortages[5].

How is OMNIPAQUE 180 expected to perform in the future market?

OMNIPAQUE 180 is expected to remain a key player in the growing market for contrast agents, driven by its established safety and efficacy profile and emerging trends in medical imaging technology.

Sources

1. Regulatory Decision Summary for Omnipaque - Health Canada
2. OMNIPAQUE (iohexol) oral solution - FDA
3. The Society for Vascular Surgery practice guidelines - Journal of Vascular Surgery
4. OMNIPAQUE™ (iohexol) Injection - FDA
5. Drug Shortage Report for OMNIPAQUE 180 - Drug Shortages Canada