CLINICAL TRIALS PROFILE FOR OMNIPAQUE 9

All Clinical Trials for Omnipaque 9

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00938561 ↗	Evaluation of New Markers to Assess Kidney Function	Withdrawn	Dialysis Clinic, Inc.		2009-09-01	Glomerular filtration rate (GFR) is widely accepted as the best index of kidney function in health and disease, and accurate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.
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.
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.

Clinical Trial Conditions for Omnipaque 9

Condition Name

Condition Name for Omnipaque 9
Intervention	Trials
Lung Cancer Non-Small Cell Cancer (NSCLC)	1
Chronic Kidney Disease	1
Uterine Fibroids	1
HIV	1

Condition MeSH

Condition MeSH for Omnipaque 9
Intervention	Trials
Coronary Artery Disease	3
Myocardial Ischemia	2
Renal Insufficiency	2
Bursitis	1

Clinical Trial Locations for Omnipaque 9

Trials by Country

+

−

Trials by Country for Omnipaque 9
Location	Trials
United States	48
France	2
Puerto Rico	1
Korea, Republic of	1
Canada	1

Trials by US State

+

−

Trials by US State for Omnipaque 9
Location	Trials
California	4
Minnesota	3
Pennsylvania	3
Ohio	2
Maryland	2

Clinical Trial Progress for Omnipaque 9

Clinical Trial Phase

Clinical Trial Phase for Omnipaque 9
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Omnipaque 9
Clinical Trial Phase	Trials
Completed	8
Recruiting	7
Not yet recruiting	6

Clinical Trial Sponsors for Omnipaque 9

Sponsor Name

Sponsor Name for Omnipaque 9
Sponsor	Trials
National Cancer Institute (NCI)	2
GE Healthcare	2
University of California, San Diego	2

Sponsor Type

Sponsor Type for Omnipaque 9
Sponsor	Trials
Other	32
Industry	12
NIH	4

OMNIPAQUE: A Comprehensive Review of Clinical Trials, Market Analysis, and Projections

Introduction

OMNIPAQUE, a non-ionic, water-soluble contrast medium containing the active ingredient iohexol, is widely used in various radiographic and CT imaging procedures. This article delves into the recent clinical trials, market analysis, and future projections for OMNIPAQUE, particularly focusing on its oral and intravenous formulations.

Clinical Trials Overview

Adult Indications

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

Pediatric Indications

Studies IOH-1058 and N-121 provided evidence for the safety and efficacy of OMNIPAQUE in pediatric patients. IOH-1058, which included adolescent patients, showed comparable efficacy and safety between OMNIPAQUE and the active control barium sulfate. The results supported the oral indication of OMNIPAQUE 300 for radiographic imaging of the GI tract in both adults and adolescents[1].

CT Imaging

For CT of the abdomen and pelvis, Study PS-641 evaluated the concomitant use of oral (diluted) and intravenous (undiluted) OMNIPAQUE. This study found that OMNIPAQUE had significantly fewer adverse events compared to gastrografin 282 and produced images of diagnostic quality comparable to the control[1].

Safety and Tolerability

Adverse Reactions

Clinical trials and post-marketing data have identified several adverse reactions associated with OMNIPAQUE. Common adverse reactions include headaches, nausea, vomiting, and dizziness. More severe reactions such as hypersensitivity, contrast-induced acute kidney injury, and cardiovascular adverse reactions can also occur. It is crucial to have emergency equipment and trained personnel available during administration[2][5].

Contraindications

OMNIPAQUE is contraindicated for parenteral administration of the oral solution, intrathecal use of certain concentrations, and in specific conditions such as pregnancy or suspected pregnancy for certain formulations. It is also contraindicated in patients with known hypersensitivity to iohexol[2][5].

Market Analysis

Market Position

OMNIPAQUE is a well-established player in the contrast media market, with a broad range of indications including radiographic imaging of the GI tract, CT scans, and various intrathecal, intra-arterial, and intravenous procedures. Its versatility and proven safety profile have contributed to its market dominance.

Competitive Landscape

The contrast media market is competitive, with other non-ionic contrast agents like iopamidol and gadolinium-based agents. However, OMNIPAQUE's extensive clinical data and wide range of approved indications give it a strong market position. The market is also influenced by advancements in imaging technologies and changing regulatory requirements[3].

Market Projections

Growth Drivers

The demand for OMNIPAQUE is expected to grow driven by increasing diagnostic imaging procedures, an aging population, and advancements in medical imaging technologies. The expansion of indications, particularly in pediatric and adult GI tract imaging, will further boost its market share.

Market Trends

The trend towards non-ionic, low-osmolar contrast agents is expected to continue, favoring OMNIPAQUE. Additionally, the integration of AI and machine learning in medical imaging will enhance the diagnostic quality and efficiency of procedures using OMNIPAQUE, potentially increasing its adoption.

Regulatory Environment

Recent Approvals

Recent regulatory approvals have expanded the indications for OMNIPAQUE, including new routes of administration and indications for radiographic imaging of the GI tract and CT of the abdomen and pelvis. These approvals have been based on comprehensive clinical trials demonstrating safety, tolerability, and efficacy[1].

Future Regulatory Landscape

The regulatory environment is expected to remain stringent, with a focus on safety and efficacy. Future approvals will likely be contingent on robust clinical data, and manufacturers will need to comply with evolving regulatory standards.

Key Takeaways

• Clinical Trials: OMNIPAQUE has demonstrated safety, tolerability, and efficacy in various clinical trials, supporting its expanded indications.
• Safety and Tolerability: While generally safe, OMNIPAQUE can cause adverse reactions, and its use is contraindicated in certain conditions.
• Market Analysis: OMNIPAQUE holds a strong market position due to its broad indications and proven safety profile.
• Market Projections: The market for OMNIPAQUE is expected to grow driven by increasing diagnostic imaging procedures and advancements in medical imaging technologies.
• Regulatory Environment: Recent approvals have expanded OMNIPAQUE's indications, and future approvals will depend on robust clinical data and compliance with regulatory standards.

FAQs

What are the new indications for OMNIPAQUE?

OMNIPAQUE has been approved for new indications including radiographic imaging of the GI tract (esophagus, stomach, small bowel, and colon) in adults and pediatrics, and CT of the abdomen and pelvis in conjunction with intravenous administration[1].

What are the common adverse reactions associated with OMNIPAQUE?

Common adverse reactions include headaches, nausea, vomiting, and dizziness. More severe reactions such as hypersensitivity and cardiovascular adverse reactions can also occur[2][5].

Is OMNIPAQUE contraindicated in any conditions?

Yes, OMNIPAQUE is contraindicated for parenteral administration of the oral solution, intrathecal use of certain concentrations, and in specific conditions such as pregnancy or suspected pregnancy for certain formulations[2][5].

What drives the demand for OMNIPAQUE in the market?

The demand for OMNIPAQUE is driven by increasing diagnostic imaging procedures, an aging population, and advancements in medical imaging technologies[3].

What are the future market trends for OMNIPAQUE?

The trend towards non-ionic, low-osmolar contrast agents is expected to continue, favoring OMNIPAQUE. Integration of AI and machine learning in medical imaging will also enhance its adoption[3].

Sources

1. Regulatory Decision Summary for Omnipaque. Health Products and Food Branch Inspectorate.
2. OMNIPAQUE (iohexol) oral solution. FDA.
3. Comparative Investigation of IV Iohexol and Iopamidol: Effect on Renal Function. American Journal of Roentgenology.
4. OMNIPAQUE™ (iohexol) Injection. FDA.
5. OMNIPAQUE. GE Healthcare.