You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: July 10, 2025

CLINICAL TRIALS PROFILE FOR OMNIPAQUE 70


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for Omnipaque 70

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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Omnipaque 70

Condition Name

Condition Name for Omnipaque 70
Intervention Trials
Hypothyroidism 1
Mesothelioma 1
Acute Kidney Injury 1
Contrast Media Reaction 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Omnipaque 70
Intervention Trials
Coronary Artery Disease 3
Renal Insufficiency 2
Myocardial Ischemia 2
Acute Kidney Injury 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Omnipaque 70

Trials by Country

Trials by Country for Omnipaque 70
Location Trials
United States 48
France 2
Colombia 1
Puerto Rico 1
Korea, Republic of 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Omnipaque 70
Location Trials
California 4
Pennsylvania 3
Minnesota 3
Ohio 2
Maryland 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Omnipaque 70

Clinical Trial Phase

Clinical Trial Phase for Omnipaque 70
Clinical Trial Phase Trials
Phase 4 7
Phase 3 1
Phase 2 1
[disabled in preview] 7
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Omnipaque 70
Clinical Trial Phase Trials
Completed 8
Recruiting 7
Not yet recruiting 6
[disabled in preview] 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Omnipaque 70

Sponsor Name

Sponsor Name for Omnipaque 70
Sponsor Trials
National Cancer Institute (NCI) 2
University of California, San Diego 2
GE Healthcare 2
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Omnipaque 70
Sponsor Trials
Other 32
Industry 12
NIH 4
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

OMNIPAQUE (iohexol): Clinical Trials, Market Analysis, and Projections

Last updated: December 31, 2024

Introduction

OMNIPAQUE, a nonionic, water-soluble x-ray contrast medium containing iohexol, has been a significant player in the medical imaging field. This article will delve into the recent clinical trials, market analysis, and future projections for OMNIPAQUE, particularly focusing on its various formulations and indications.

Clinical Trials Overview

Adult Indications

Recent clinical trials have expanded the indications for OMNIPAQUE in adults. Two pivotal phase 3 randomized, double-blind clinical trials (N-137 and PS-632) supported the use of OMNIPAQUE 300 and OMNIPAQUE 350 for oral administration in radiographic imaging of the gastrointestinal (GI) tract, including the esophagus, stomach, small bowel, and colon. These trials demonstrated that orally administered 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 for contrast-enhanced CT of the abdomen and pelvis in adults. This study showed that OMNIPAQUE had fewer adverse events and comparable diagnostic image quality to gastrografin 282[1].

Pediatric Indications

Clinical trials have also supported the use of OMNIPAQUE in pediatric patients. Studies IOH-1058 and N-121 demonstrated favorable safety, tolerability, and diagnostic image quality for oral OMNIPAQUE in children requiring contrast-enhanced X-ray examinations of the GI tract. An open-label, non-comparative study (IOH-1030) further supported the use of diluted oral OMNIPAQUE in conjunction with IV OMNIPAQUE for contrast-enhanced CT of the abdomen and pelvis in pediatric patients[1].

Safety and Tolerability

Adverse Reactions

OMNIPAQUE has been generally well tolerated in clinical trials. Common adverse reactions in adults include diarrhea, nausea, vomiting, abdominal pain, flatulence, and headache following oral administration. For IV and intrathecal administration, adverse reactions can include headaches, pain, nausea, vomiting, and dizziness. Serious reactions such as hypersensitivity, contrast-induced acute kidney injury, and cardiovascular adverse reactions can occur but are less common[2][5].

Contraindications and Warnings

OMNIPAQUE is contraindicated for intrathecal use and parenteral use of the oral solution. It is crucial to monitor for hypersensitivity reactions, which can be life-threatening, and to minimize the risk of contrast-induced acute kidney injury by maintaining adequate hydration[2][5].

Market Analysis

Market Position

OMNIPAQUE is a well-established brand in the contrast media market, competing with other nonionic contrast agents like Visipaque and Isovue. The market for contrast media is driven by the increasing demand for diagnostic imaging procedures, particularly in the fields of gastrointestinal and abdominal imaging.

Competitive Landscape

The competition in the contrast media market is intense, with various manufacturers claiming superiority in terms of renal safety and diagnostic image quality. However, clinical evidence does not definitively support the claim that any one nonionic contrast medium is superior to all others in all aspects. For example, the NEPHRIC study did not establish Visipaque as superior to all low-osmolar contrast media (LOCM), including OMNIPAQUE[3].

Market Projections

Growth Drivers

The demand for OMNIPAQUE is expected to grow due to several factors:

  • Increasing Prevalence of Chronic Diseases: Conditions such as gastrointestinal disorders and cardiovascular diseases require diagnostic imaging, driving the demand for contrast media.
  • Advancements in Imaging Technologies: Improvements in CT and MRI technologies enhance the diagnostic capabilities, increasing the need for high-quality contrast agents.
  • Expanding Indications: Recent clinical trials have expanded the indications for OMNIPAQUE, making it a versatile option for various imaging procedures.

Market Challenges

Despite the growth drivers, the market faces challenges such as:

  • Regulatory Scrutiny: Strict regulatory requirements and the need for continuous clinical evidence to support new indications can slow market growth.
  • Competition: The presence of other nonionic contrast agents and ongoing research to develop safer and more effective alternatives pose competitive challenges.

Future Outlook

Emerging Trends

The future of OMNIPAQUE and the broader contrast media market will be shaped by several trends:

  • Personalized Medicine: There is a growing interest in personalized contrast media dosing based on patient-specific factors such as kidney function and body weight.
  • Sustainability: Manufacturers are focusing on more sustainable packaging and production methods, which could influence market preferences.

Innovations and Research

Continuous research is aimed at improving the safety and efficacy of OMNIPAQUE. For instance, studies on prophylactic measures to reduce contrast-induced nephropathy and other adverse reactions are ongoing. Innovations in formulation and delivery methods, such as more palatable oral solutions, could also enhance patient compliance and comfort.

"OMNIPAQUE 300 and OMNIPAQUE 350 are indicated in adults for oral administration for radiographic imaging of the GI tract (including esophagus, stomach and small bowel and colon)" - Regulatory Decision Summary for Omnipaque[1].

Key Takeaways

  • Expanded Indications: OMNIPAQUE has received new indications for oral and rectal administration in adults and pediatrics for GI tract imaging and CT of the abdomen and pelvis.
  • Safety Profile: The drug is generally well tolerated, but serious adverse reactions can occur, necessitating careful patient monitoring.
  • Market Position: OMNIPAQUE remains a significant player in the contrast media market, driven by increasing demand for diagnostic imaging.
  • Future Outlook: The market will be influenced by emerging trends in personalized medicine, sustainability, and ongoing research to improve safety and efficacy.

FAQs

What are the new indications for OMNIPAQUE?

OMNIPAQUE has been approved for new indications including oral administration for radiographic imaging of the GI tract in adults and pediatrics, and for CT of the abdomen and pelvis in conjunction with IV administration.

What are the common adverse reactions associated with OMNIPAQUE?

Common adverse reactions include diarrhea, nausea, vomiting, abdominal pain, and headache for oral administration, and headaches, pain, nausea, and dizziness for IV and intrathecal administration.

Is OMNIPAQUE contraindicated for any specific uses?

Yes, OMNIPAQUE is contraindicated for intrathecal use and parenteral use of the oral solution.

How does OMNIPAQUE compare to other nonionic contrast media?

While OMNIPAQUE is competitive, clinical evidence does not definitively establish it as superior to all other nonionic contrast media in all aspects.

What are the growth drivers for the OMNIPAQUE market?

The market is driven by the increasing prevalence of chronic diseases, advancements in imaging technologies, and expanding indications for OMNIPAQUE.

Sources

  1. Regulatory Decision Summary for Omnipaque - Health Canada[1].
  2. OMNIPAQUE (iohexol) oral solution - FDA Label[2].
  3. Case 3:03-cv-06025-FLW-TJB Document 625 Filed 03/25 - GovInfo[3].
  4. OMNIPAQUEâ„¢ (iohexol) Injection - FDA Label[4].
  5. OMNIPAQUE (iohexol) oral solution - FDA Label[5].

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.