CLINICAL TRIALS PROFILE FOR OMNIPAQUE 350

All Clinical Trials for Omnipaque 350

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 350

Condition Name

Condition Name for Omnipaque 350
Intervention	Trials
Hypothyroidism	1
Acute Kidney Injury	1
Mesothelioma	1
Contrast Media Reaction	1

Condition MeSH

Condition MeSH for Omnipaque 350
Intervention	Trials
Coronary Artery Disease	3
Myocardial Ischemia	2
Renal Insufficiency	2
Diabetes Mellitus	1

Clinical Trial Locations for Omnipaque 350

Trials by Country

Trials by Country for Omnipaque 350
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 350
Location	Trials
California	4
Pennsylvania	3
Minnesota	3
Ohio	2
Maryland	2

Clinical Trial Progress for Omnipaque 350

Clinical Trial Phase

Clinical Trial Phase for Omnipaque 350
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Omnipaque 350
Clinical Trial Phase	Trials
Completed	8
Recruiting	7
Not yet recruiting	6

Clinical Trial Sponsors for Omnipaque 350

Sponsor Name

Sponsor Name for Omnipaque 350
Sponsor	Trials
National Cancer Institute (NCI)	2
GE Healthcare	2
University of California, San Diego	2

Sponsor Type

Sponsor Type for Omnipaque 350
Sponsor	Trials
Other	32
Industry	12
NIH	4

OMNIPAQUE 350: Clinical Trials, Market Analysis, and Projections

Introduction

OMNIPAQUE 350, a non-ionic, water-soluble contrast medium containing the active ingredient iohexol, is widely used in various radiographic and CT imaging procedures. This article provides an update on the clinical trials, market analysis, and future projections for OMNIPAQUE 350.

Clinical Trials Update

Adult Indications

Several clinical trials have supported the use of OMNIPAQUE 350 in adults. Two pivotal phase 3 randomized, double-blind clinical trials (N-137 and PS-632) demonstrated the safety, tolerability, and efficacy of OMNIPAQUE 350 for oral administration in radiographic imaging of the gastrointestinal (GI) tract. These studies showed that OMNIPAQUE 350 had comparable or significantly better diagnostic image quality compared to the active control gastrografin 370[1].

Another study, PS-641, evaluated the concomitant use of oral (diluted) and intravenous (IV) OMNIPAQUE 350 for CT of the abdomen and pelvis. This study found that OMNIPAQUE 350 had fewer adverse events and comparable diagnostic image quality to gastrografin 282[1].

Pediatric Indications

For pediatric patients, studies such as IOH-1058 and N-121 have shown favorable safety, tolerability, and diagnostic image quality for OMNIPAQUE 350. The study IOH-1058, which included adolescent patients, demonstrated comparable efficacy and safety between OMNIPAQUE 300 and OMNIPAQUE 350 for GI tract imaging. An open-label, non-comparative study (IOH-1030) supported the use of diluted OMNIPAQUE 350 in conjunction with IV OMNIPAQUE for CT of the abdomen and pelvis in pediatric patients[1].

Pharmacokinetic Bioequivalence

A Phase 1 clinical trial comparing CE-Iohexol (a formulation containing iohexol and CAPTISOL) to OMNIPAQUE 350 demonstrated pharmacokinetic bioequivalence. This study showed similar area under the concentration-time curve (AUC) and maximum concentration (Cmax) values, indicating that CE-Iohexol is bioequivalent to OMNIPAQUE 350 following IV administration[4].

Market Analysis

Market Demand

OMNIPAQUE 350 is a critical component in the diagnostic imaging market, particularly in emergency departments, cardiac centers, and specialized stroke units. The demand for this product is high due to its broad range of indications, including radiographic imaging of the GI tract, CT of the abdomen and pelvis, and various angiographic procedures[5].

Supply Chain Challenges

Recent supply disruptions, such as the shutdown of the GE production plant in Shanghai due to COVID-19, have raised significant concerns about the availability of OMNIPAQUE 350. These disruptions have led to allotments being reduced to 20% of normal supply levels. However, GE has taken steps to mitigate these disruptions by reopening the Shanghai plant at reduced capacity and shifting production to a facility in Cork, Ireland[5].

Competitive Landscape

The contrast media market is competitive, with several other products available, such as gastrografin and barium sulfate. However, OMNIPAQUE 350 has established itself as a preferred choice due to its favorable safety profile, tolerability, and diagnostic image quality. The bioequivalence of CE-Iohexol to OMNIPAQUE 350 also suggests potential future competition, but OMNIPAQUE's established market presence and clinical evidence support its continued market dominance[1][4].

Market Projections

Short-Term Projections

In the short term, the market for OMNIPAQUE 350 is expected to stabilize as GE ramps up production and distribution. The reopening of the Shanghai plant and the additional production capacity in Cork, Ireland, are anticipated to increase supply levels, reducing the current allotment constraints. This should help in meeting the high demand from hospitals and health systems[5].

Long-Term Projections

Long-term projections indicate a steady growth in the demand for OMNIPAQUE 350, driven by the increasing need for advanced diagnostic imaging procedures. The aging population and the rising incidence of chronic diseases are expected to increase the demand for diagnostic imaging services, thereby boosting the market for contrast media like OMNIPAQUE 350.

Technological Advancements

Advancements in imaging technologies, such as improved CT scanners and digital imaging techniques, are likely to enhance the diagnostic capabilities of OMNIPAQUE 350. These advancements could further solidify its position in the market and drive future growth[3].

Key Takeaways

• Clinical Efficacy: OMNIPAQUE 350 has demonstrated strong clinical efficacy and safety in various radiographic and CT imaging procedures.
• Market Demand: High demand driven by its critical role in diagnostic imaging across multiple medical specialties.
• Supply Chain: Recent disruptions have impacted supply, but GE is taking steps to restore production and distribution.
• Competitive Advantage: Established market presence and favorable clinical profile position OMNIPAQUE 350 as a leading choice in contrast media.
• Future Growth: Expected growth driven by increasing demand for diagnostic imaging and technological advancements.

FAQs

What are the primary indications for OMNIPAQUE 350?

OMNIPAQUE 350 is indicated for radiographic imaging of the GI tract, CT of the abdomen and pelvis, and various angiographic procedures in both adults and pediatric patients[1][3].

What were the findings of the Phase 1 clinical trial comparing CE-Iohexol to OMNIPAQUE 350?

The trial demonstrated pharmacokinetic bioequivalence between CE-Iohexol and OMNIPAQUE 350, with similar AUC and Cmax values, indicating that CE-Iohexol is bioequivalent to OMNIPAQUE 350 following IV administration[4].

How have recent supply disruptions affected the availability of OMNIPAQUE 350?

The COVID-19-related shutdown of the GE production plant in Shanghai led to reduced supply levels, with allotments currently at 20% of normal levels. However, GE is working to restore production and distribution[5].

What steps is GE taking to mitigate the supply disruptions?

GE has reopened the Shanghai plant at reduced capacity and is shifting some production to a facility in Cork, Ireland, to increase supply levels[5].

What are the long-term market projections for OMNIPAQUE 350?

Long-term projections indicate steady growth driven by increasing demand for diagnostic imaging services, technological advancements, and the established market presence of OMNIPAQUE 350.

Sources

1. Regulatory Decision Summary for Omnipaque - Health Products and Food Branch Inspectorate.
2. OMNIPAQUE (iohexol) oral solution - FDA.
3. OMNIPAQUE (iohexol) oral solution - GE Healthcare.
4. Ligand Presents Positive Results from Phase 1 Clinical Trial of Captisol-enabled Iohexol - Business Wire.
5. AHA to GE Re: General Electric Omnipaque Supply Disruption and Product - American Hospital Association.