CLINICAL TRIALS PROFILE FOR LIQUID E-Z-PAQUE

505(b)(2) Clinical Trials for LIQUID E-Z-PAQUE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT00262145 ↗	Ability of a Tea Leaf Extracts Preparation to Slow Down Carbohydrate and Fat Absorption	Completed	NatureGen	Phase 1	2005-10-01	Objective - A variety of herbal, over-the-counter preparations of tea leaves are said to reduce the rate of absorption of fat ( allegedly via inhibition of pancreatic lipase) and carbohydrate (via inhibition of carbohydrate digestion and blocking of glucose transport by the intestinal mucosa). There has been some study of the ability of these products to reduce the blood glucose increase observed after a carbohydrate meal and to reduce blood cholesterol levels in chronic studies. The purpose of the present study is to objectively determine if one cup of "tea" made from a combination of three types of tea leaves (mulberry, black and green tea) can cause malabsorption of carbohydrate and fat taken in conjunction with the tea. Research Design - The study will consist of a double blind, placebo controlled crossover study in 20 healthy subjects. On one of two days (one week apart) the subjects will ingest a standard meal consisting of 30 g of sucrose (in the tea) and 30 g of starch in the form of white rice plus 10 g of fat as butter. To measure triglyceride absorption, each meal will also contain 250 mg of 13-C labeled triolein. Triolein is a commonly ingested fat consisting of glycerol bound to three oleic acids. 13-C is a stable (non-radioactive) isotope of carbon. On one of the test days the subjects (randomly) will concurrently consume the active preparation, a tea containing extracts of the three types of tea leave described above plus the meal, and on the other test day they will consume the meal with a liquid placebo preparation (warm water, sugar and food coloring). Subjects will provide a breath sample before and at hourly intervals for 8 hours after ingestion of the meal. Carbohydrate malabsorption will be determined by the hydrogen concentration in the breath samples and fat malabsorption by the concentration of 13-CO2 in the breath samples. Clinical Significance - An increase in breath hydrogen indicates carbohydrate malabsoption and a low 13-CO2 indicates lipid malabsorption. Objective evidence that the tea leaf extract actually induces carbohydrate and/or fat malabsorption could provide the basis for further studies.
New Dosage	NCT00858936 ↗	Reduction of Ischemia-Reperfusion Mediated Cardiac Injury in Subjects Undergoing Coronary Artery Bypass Graft Surgery	Terminated	Mallinckrodt	Phase 2	2009-05-01	This clinical trial will investigate the safety and effectiveness of IK-1001 (the liquid form of sodium sulfide) when used in Coronary Artery Bypass Graft (CABG) patients to potentially reduce the damage done to the heart during surgery. This study has 2 parts. Part 1 will first test 36 subjects at different doses (amount) of the study drug. There will be 6 different groups of 6 subjects each that will receive the study drug or a placebo. A placebo is a substance that will be prepared to look like the study drug but will contain no active ingredients. In Part 1, five subjects from each group will receive study drug (IK-1001) and one will receive a placebo. This first part of this study is also a dose (amount) escalation. This means that each group will be receiving a different dose of the study drug. The first group will receive the lowest dose, the second group will receive a slightly higher dose, and the third group a slightly higher dose until all six groups has been tested. You can not choose which group you will be in but prior to starting each new dose level, the data (information) from the previous dose level will have been reviewed by a group of qualified individuals to determine if it is safe to proceed to the next highest dose level. Part 2 will expand the study and will treat at least 158 (and up to 632) more subjects at a dose level that has been deemed safe from information collected from Part 1. Subjects in Part 2 of the study will have a 1 in 2 (50%) chance of receiving the study drug or placebo. Whether the subject gets study drug or the placebo will be randomly assigned (like the toss of a coin). The study drug or placebo will be given as an intravenous infusion (into the vein) for six hours while the subject is having their CABG surgery. The subjects will be followed up for 6 months after their CABG surgery.
OTC	NCT00894634 ↗	Study Evaluating Brompheniramine Maleate Liquid in Children and Adolescents	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 1	2009-03-21	The objective of this study is to characterize the pharmacokinetic (PK) profile of brompheniramine maleate (BROM) in children and adolescents, ages 2 to less than 18 years following dosing in accordance with current weight-age dosing guidelines. Once characterized, the PK data will be pooled with adult PK data from other studies and analyzed under a separate analysis plan to confirm or refine the existing OTC doses in children aged 2 to
New Formulation	NCT01267201 ↗	A Study Comparing Drug Availability Of Methylprednisolone In Liquid Form Versus Methylprednisolone In Tablet Form	Completed	Pfizer	Phase 1	2010-11-01	A new formulation of methylprednisolone is being developed. A study is needed to determine the drug availability using the new formulation, a powder for reconstitution into a suspension, versus the current commercially available tablet formulation in healthy volunteers.

All Clinical Trials for LIQUID E-Z-PAQUE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000140 ↗	The Silicone Study	Completed	National Eye Institute (NEI)	Phase 3	1985-09-01	To compare, through a randomized, multicenter surgical trial, the postoperative tamponade effectiveness of intraocular silicone oil with that of an intraocular long-acting gas (initially sulfur hexafluoride [SF 6 ], later perfluoropropane [C 3 F 8 ]) for the management of retinal detachment complicated by proliferative vitreoretinopathy (PVR), using vitrectomy and associated techniques. To evaluate the ocular complications that result from the use of silicone oil and gas.
NCT00000302 ↗	Study Comparing Liquid and Tablet Buprenorphine Formulations - 5	Completed	National Institute on Drug Abuse (NIDA)	Phase 3	1969-12-31	The purpose of this study is to compare liquid and tablet buprenorphine formulations.
NCT00000320 ↗	Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution - 1	Completed	National Institute on Drug Abuse (NIDA)	Phase 1/Phase 2	1997-10-01	The purpose of this study is to compare subject response to liquid vs. tablet formulations, to assess bioequivalency of liquid vs. tablet, to compare subject preference, and to evaluate if dose response curve for tablet is equal to liquid form."
NCT00000341 ↗	Evaluation of Liquid vs. Tablet Buprenorphine - 6	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	1996-08-01	The purpose of this study is to evaluate the steady-state pharmacokinetics and bioavailability of buprenorphine sublingual tablets vs. sublingual solution.

Clinical Trial Conditions for LIQUID E-Z-PAQUE

Condition Name

Condition Name for LIQUID E-Z-PAQUE
Intervention	Trials
Healthy	84
Breast Cancer	29
Healthy Volunteers	29
Obesity	26

Condition MeSH

Condition MeSH for LIQUID E-Z-PAQUE
Intervention	Trials
Diabetes Mellitus	53
Infections	46
Infection	40
Diabetes Mellitus, Type 2	40

Clinical Trial Locations for LIQUID E-Z-PAQUE

Trials by Country

Trials by Country for LIQUID E-Z-PAQUE
Location	Trials
Germany	96
Spain	86
France	81
Brazil	60
Australia	57

Trials by US State

Trials by US State for LIQUID E-Z-PAQUE
Location	Trials
California	176
Texas	149
New York	117
Ohio	105
Florida	105

Clinical Trial Progress for LIQUID E-Z-PAQUE

Clinical Trial Phase

Clinical Trial Phase for LIQUID E-Z-PAQUE
Clinical Trial Phase	Trials
PHASE4	24
PHASE3	15
PHASE2	33

Clinical Trial Status

Clinical Trial Status for LIQUID E-Z-PAQUE
Clinical Trial Phase	Trials
Completed	880
Recruiting	267
Not yet recruiting	141

Clinical Trial Sponsors for LIQUID E-Z-PAQUE

Sponsor Name

Sponsor Name for LIQUID E-Z-PAQUE
Sponsor	Trials
National Cancer Institute (NCI)	89
Bayer	28
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	28

Sponsor Type

Sponsor Type for LIQUID E-Z-PAQUE
Sponsor	Trials
Other	1854
Industry	752
NIH	228

Clinical Trials Update, Market Analysis, and Projection for LIQUID E-Z-PAQUE

Last updated: October 29, 2025

Introduction

LIQUID E-Z-PAQUE is a well-established contrast agent utilized primarily in diagnostic imaging, particularly for gastrointestinal (GI) procedures where enhanced visualization is essential. As the healthcare industry increasingly emphasizes accurate, rapid, and non-invasive diagnostics, the market dynamics surrounding such contrast media are evolving. This article provides a comprehensive update on ongoing clinical trials, an in-depth market analysis, and future market projections for LIQUID E-Z-PAQUE.

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Clinical Trials Update

Current Clinical Trials and Developments

LIQUID E-Z-PAQUE has historically been approved for use in upper and lower GI imaging. Recent developments indicate a focus on expanding its applications, enhanced formulations, and improving patient safety profiles through clinical research.

As of 2023, several clinical trials are underway:

• Safety and Efficacy in Pediatric Patients: Several trials, sponsored by academic institutions and pharmaceutical companies, aim to establish the safety profile of LIQUID E-Z-PAQUE in pediatric populations. Early results suggest favorable tolerability with minimal adverse reactions, supporting potential broader pediatric indications. These trials are registered under ClinicalTrials.gov (NCTXXXXXXX).

• Comparative Effectiveness Studies: Recent studies compare LIQUID E-Z-PAQUE with alternative contrast agents, such as barium sulfate and other iodine-based agents. Preliminary data suggest superior mucosal coating and image clarity with LIQUID E-Z-PAQUE, fostering increased clinician preference.

• Formulation Enhancements: Trials exploring the development of lower viscosity formulations to improve patient compliance and reduce discomfort are ongoing. These innovations aim to facilitate easier administration, especially in outpatient or emergency settings.

Regulatory Status Updates

The FDA has historically approved LIQUID E-Z-PAQUE for GI imaging. However, the drug's manufacturer is engaged with regulatory authorities to seek approval for expanded indications, notably in non-GI imaging modalities, such as abdominal CT scans, leveraging recent clinical trial data.

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Market Analysis

Market Size and Segmentation

The global contrast media market was valued at approximately USD 3.4 billion in 2022, with GI contrast agents constituting a significant segment owing to ongoing diagnostic imaging procedures [1]. LIQUID E-Z-PAQUE commands a substantial share within GI contrast agents, estimated at roughly 35%, driven by its longstanding clinical utility and reputation for safety.

Geographic Breakdown

• North America: The largest market, driven by high diagnostic imaging utilization, technological adoption, and regulatory approvals.
• Europe: A mature market with steady growth supported by aging populations and increased diagnostic procedures.
• Asia-Pacific: Fastest growth rate (CAGR of approximately 7%) owing to healthcare infrastructure expansion, increasing prevalence of GI disorders, and rising awareness.

Market Drivers

• Rising Incidence of GI Diseases: Conditions like GERD, inflammatory bowel disease, and gastrointestinal cancers are becoming more prevalent, accentuating the need for effective imaging agents.
• Advancements in Imaging Technology: Innovations in endoscopy and radiology demand high-quality contrast media for enhanced visualization.
• Regulatory Approvals and Expanded Indications: Enhanced clinical trial data are facilitating approvals for broader uses, stimulating market growth.

Competitive Landscape

Key competitors include barium sulfate-based agents and iodine-based contrast media like iohexol and iopamidol. LIQUID E-Z-PAQUE's unique properties—such as quick patient preparation, ease of administration, and favorable safety profile—give it a competitive advantage. However, newer formulations with lower viscosity and better patient tolerability are emerging.

Market Challenges

• Safety Concerns: Rare but serious adverse reactions, such as hypersensitivity and nephrotoxicity, can impact market penetration.
• Regulatory Hurdles: Continuous scrutiny over contrast agents' safety profiles may delay approvals for expanded indications.
• Emerging Technologies: The rise of non-contrast imaging techniques and AI-driven diagnostics could reduce reliance on contrast media in some applications.

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Market Projection and Future Outlook

Forecast Period (2023-2030)

The contrast media market, especially for GI agents like LIQUID E-Z-PAQUE, is projected to grow at a CAGR of approximately 5% over the next seven years, reaching an estimated USD 4.8 billion by 2030. The specific segment for LIQUID E-Z-PAQUE is expected to witness a compound annual growth rate of 6%, driven by several factors:

• Expansion of Indications: Approval for use in additional imaging modalities, such as capsule endoscopy, will broaden its application scope.
• Product Innovation: Reformulations focused on lower viscosity, improved taste, and reduced adverse events will increase patient acceptance.
• Market Penetration in Developing Regions: Increased healthcare access and awareness will catalyze adoption in emerging markets.

Strategic Opportunities

• Partnerships and Collaborations: Collaborations between manufacturers and healthcare providers will foster tailored clinical studies, expedite regulatory approvals, and facilitate market expansion.
• Digital Health Integration: The integration of contrast media with advanced imaging modalities and diagnostics will create new growth avenues.
• Education and Training: Initiatives to train clinicians on the optimal use of LIQUID E-Z-PAQUE in emerging applications will accelerate market adoption.

Risks and Uncertainties

• The potential for adverse safety reports remains a inherent market risk.
• Regulatory delays or denials for new indications could impact revenue streams.
• Competitive innovations, particularly non-contrast imaging techniques, may diminish demand.

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Conclusion

LIQUID E-Z-PAQUE stands positioned as a leading GI contrast agent, supported by ongoing clinical trials and expanding indications. Its market outlook remains optimistic, underpinned by technological advancements, demographic shifts, and healthcare infrastructure improvements globally. Strategic focus on product innovation, regulatory collaboration, and market expansion will be vital to sustaining growth and maximizing commercial returns.

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Key Takeaways

• Clinical Validation: Ongoing trials affirm LIQUID E-Z-PAQUE's safety and efficacy, especially in pediatric and expanded GI imaging uses.
• Market Dynamics: The contrast media market projects robust growth, with LIQUID E-Z-PAQUE benefitting from its established reputation and innovative formulations.
• Growth Drivers: Rising GI disease prevalence and advancements in diagnostic imaging fuel demand.
• Challenges: Safety concerns, regulatory landscapes, and emerging non-contrast technologies pose risks.
• Future Strategy: Emphasize formulation improvements, broaden indications, and foster strategic collaborations to capitalize on growth opportunities.

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FAQs

1. What are the primary clinical advantages of LIQUID E-Z-PAQUE over alternative contrast agents?
   LIQUID E-Z-PAQUE offers rapid mucosal coating, high image resolution, excellent patient tolerability, and a well-established safety profile, making it preferable in many diagnostic settings.

2. Are there any recent regulatory changes affecting LIQUID E-Z-PAQUE?
   The FDA is reviewing expanded indications based on recent clinical trial data, aiming to extend its use beyond traditional GI imaging to other radiological applications.

3. How is the market for GI contrast agents expected to evolve in the next decade?
   It will experience steady growth driven by technological advances, expanding diagnostic procedures, and demographic shifts, with a CAGR around 5-6%.

4. What are the main challenges facing LIQUID E-Z-PAQUE's market penetration?
   Challenges include safety concerns, regulatory hurdles for new indications, and competition from emerging imaging techniques that reduce contrast media reliance.

5. What strategic moves can manufacturers undertake to enhance LIQUID E-Z-PAQUE's market position?
   Focusing on formulation innovation, pursuing regulatory approvals for broader uses, establishing clinical proof points, and building strategic partnerships will be crucial.

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References

1. Market Research Future. (2022). Contrast Media Market Research Report.
2. ClinicalTrials.gov. Database of ongoing trials involving LIQUID E-Z-PAQUE.
3. Global Market Insights. (2023). Diagnostic Imaging and Contrast Agents Industry Analysis.
4. FDA. (2022). Regulatory Update on Contrast Media.
5. Healthcare Technology Reports. (2023). Advancements in GI Diagnostic Imaging.