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 <12 yrs and adolescents aged 12 to <18 yrs.

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."

Clinical Trial Conditions for Liquid E-z-paque

Condition Name

Condition Name for Liquid E-z-paque
Intervention	Trials
Healthy	79
Healthy Volunteers	26
Breast Cancer	26

Condition MeSH

Condition MeSH for Liquid E-z-paque
Intervention	Trials
Diabetes Mellitus	50
Infections	46
Infection	40

Clinical Trial Locations for Liquid E-z-paque

Trials by Country

Trials by Country for Liquid E-z-paque
Location	Trials
Italy	99
Germany	93
Spain	79
France	79
Brazil	59

Trials by US State

Trials by US State for Liquid E-z-paque
Location	Trials
California	169
Texas	143
New York	110
Maryland	101
Ohio	99

Clinical Trial Progress for Liquid E-z-paque

Clinical Trial Phase

Clinical Trial Phase for Liquid E-z-paque
Clinical Trial Phase	Trials
Phase 4	265
Phase 3	163
Phase 2/Phase 3	47

Clinical Trial Status

Clinical Trial Status for Liquid E-z-paque
Clinical Trial Phase	Trials
Completed	853
Recruiting	225
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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	27
M.D. Anderson Cancer Center	27

Sponsor Type

Sponsor Type for Liquid E-z-paque
Sponsor	Trials
Other	1699
Industry	715
NIH	225

Liquid E-Z Paque: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction

Liquid E-Z Paque, a radiographic contrast agent containing barium sulfate, is widely used for single contrast radiographic examinations of the esophagus, stomach, and small bowel. This article delves into the clinical trials, market analysis, and future projections for this essential diagnostic tool.

Clinical Trials and Efficacy

Mechanism of Action

Liquid E-Z Paque works by utilizing barium sulfate, which is opaque to x-rays, thereby acting as a positive contrast agent for radiographic studies. This mechanism allows for clear visualization of the gastrointestinal (GI) tract, aiding in the diagnosis of various GI conditions[1][3][5].

Clinical Studies

The efficacy of Liquid E-Z Paque is supported by successful opacification of the esophagus, stomach, and small bowel during single contrast radiographic procedures. Clinical studies and experience have demonstrated its safety and effectiveness in both adult and pediatric patients. The FDA approved the use of Liquid E-Z Paque in 2016, following a supplemental New Drug Application (sNDA) that included a pediatric assessment under the Pediatric Research Equity Act (PREA)[2].

Pediatric Use

In pediatric patients, the dosing recommendations are based on the patient's age and the volume of the GI tract. For example, for small bowel examinations, the recommended doses range from 30 to 75 mL for patients under 2 years and up to 480 mL for patients between 2 and 17 years old. The safety profile in pediatric patients is well-documented, although special precautions are advised for those with conditions like asthma, food allergies, cystic fibrosis, or Hirschsprung disease[1][2].

Market Analysis

Market Presence

Liquid E-Z Paque has been marketed since 2016, following its approval by the FDA. It is part of the broader market for radiographic contrast agents, which are essential tools in diagnostic imaging. The product is supplied by Bracco Diagnostics, a well-established player in the diagnostic imaging industry[2].

Competitors and Alternatives

The market for GI contrast agents includes several competitors, such as READI-CAT 2 and READI-CAT 2 SMOOTHIE, also from Bracco Diagnostics. However, Liquid E-Z Paque's formulation as a 60% w/v oral suspension sets it apart, offering a concentrated and effective option for GI tract visualization[2][3].

Market Trends

The demand for diagnostic imaging agents is increasing due to the growing need for accurate and early diagnosis of GI disorders. Advances in imaging technologies and the expanding aging population, which is more prone to GI issues, are driving the market growth. Liquid E-Z Paque benefits from these trends due to its efficacy and safety profile[5].

Dosage and Administration

Recommended Dosage

The optimal dose of Liquid E-Z Paque varies based on the patient's size and the specific procedure. For adults, typical doses range from 150 to 750 mL, depending on whether the examination focuses on the esophagus, stomach, or small bowel. Pediatric doses are adjusted according to the patient's age and GI volume[1][3].

Administration Instructions

The product must be shaken vigorously before administration to ensure full suspension. It is administered undiluted, and patients are advised to have nothing by mouth for a specified period before the examination. Post-procedure hydration is recommended to prevent constipation and other complications[1][3].

Safety and Contraindications

Contraindications

Liquid E-Z Paque is contraindicated in patients with certain conditions, such as tracheo-esophageal fistula, especially in pediatric patients. It is also contraindicated in patients with known or suspected perforation of the GI tract[1][3].

Warnings and Precautions

Patients with a history of asthma or food allergies may be at increased risk for hypersensitivity reactions. Those with cystic fibrosis or Hirschsprung disease are at risk for bowel obstruction. Dehydrated patients or those with conditions that can cause constipation should be monitored closely[1][2].

Storage and Handling

Storage Conditions

Liquid E-Z Paque should be stored at USP controlled room temperature (20 to 25°C or 68 to 77°F) and protected from freezing. The product must be shaken well before use to ensure it is fully suspended[1][3].

Market Projections

Growth Drivers

The market for Liquid E-Z Paque is expected to grow driven by increasing demand for diagnostic imaging, advancements in radiographic technologies, and an aging population with higher incidence rates of GI disorders.

Market Size and Share

The global market for radiographic contrast agents is projected to expand, with Liquid E-Z Paque expected to maintain a significant market share due to its established efficacy and safety profile.

Future Developments

Future developments in the formulation and administration of Liquid E-Z Paque could include improvements in taste and texture to enhance patient compliance, as well as potential expansions into new indications or patient populations.

Key Takeaways

• Efficacy and Safety: Liquid E-Z Paque is a well-established radiographic contrast agent with a strong safety and efficacy profile in both adult and pediatric patients.
• Market Presence: It is a key player in the market for GI contrast agents, supplied by Bracco Diagnostics.
• Dosage and Administration: The product requires careful dosing and administration to ensure optimal results and minimize risks.
• Market Trends: The market is driven by increasing demand for diagnostic imaging and an aging population.
• Future Projections: The market for Liquid E-Z Paque is expected to grow, driven by these trends and potential future developments.

FAQs

What is Liquid E-Z Paque used for?

Liquid E-Z Paque is used as a radiographic contrast agent for single contrast radiographic examinations of the esophagus, stomach, and small bowel to visualize the gastrointestinal (GI) tract in adult and pediatric patients[1][3][5].

How is Liquid E-Z Paque administered?

Liquid E-Z Paque is administered orally, undiluted, after shaking the bottle vigorously to ensure full suspension. Patients should have nothing by mouth for a specified period before the examination[1][3].

What are the contraindications for Liquid E-Z Paque?

Liquid E-Z Paque is contraindicated in patients with tracheo-esophageal fistula, especially in pediatric patients, and in those with known or suspected perforation of the GI tract[1][3].

What precautions should be taken in pediatric patients?

Pediatric patients with a history of asthma or food allergies may be at increased risk for hypersensitivity reactions. Those with cystic fibrosis or Hirschsprung disease are at risk for bowel obstruction after use[1][2].

How should Liquid E-Z Paque be stored?

Liquid E-Z Paque should be stored at USP controlled room temperature (20 to 25°C or 68 to 77°F) and protected from freezing. The product must be shaken well before use to ensure it is fully suspended[1][3].

Sources

1. Drugs.com: Liquid E-Z Paque: Package Insert / Prescribing Information.
2. FDA: Summary Review for Regulatory Action - Liquid E-Z-PAQUE (barium sulfate) oral suspension.
3. Drugs.com: E-Z Paque: Package Insert / Prescribing Information.
4. DailyMed: EZ-PAQUE- barium sulfate powder, for suspension.
5. Medicines.org.uk: E-Z-Paque 96 % w/w powder for oral suspension.