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Last Updated: June 20, 2025

CLINICAL TRIALS PROFILE FOR ENTERO VU 24%


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All Clinical Trials for Entero Vu 24%

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00303784 ↗ Prostate Adenocarcinoma TransCutaneous Hormones Recruiting Medical Research Council Phase 3 2006-03-01 RATIONALE: The increasingly prolonged and extended use of androgen deprivation therapy (ADT) in the treatment of prostate cancer, usually achieved through the administration of LHRH agonists, has raised concerns about long-term toxicities, in particular osteoporosis and adverse metabolic changes which may be associated with type II diabetes and increased cardiovascular risk. An alternative approach is to investigate other methods of ADT. Oral oestrogen has been shown to be as effective as LHRH and surgical orchidectomy in achieving castrate levels of testosterone and has equivalent or improved prostate cancer outcomes but is not used routinely as first-line therapy because of the risk of cardiovascular system (CVS) complications. The CVS complications have been attributed to first-pass hepatic metabolism. Administering oestrogen parenterally avoids the entero-hepatic circulation and so is expected to mitigate the risk of CVS toxicity whilst still effectively suppressing testosterone to castrate levels. This hypothesis has been supported by results from the early stages of this trial which have provided sufficient indication of the safety and efficacy of the patches to warrant further investigation of the treatment in this setting, as recommended by the IDMC.. PURPOSE: This randomized phase III trial is studying how well the estrogen skin patch works compared with luteinizing hormone-releasing hormone agonist injections in treating patients with locally advanced or metastatic prostate cancer.
NCT00303784 ↗ Prostate Adenocarcinoma TransCutaneous Hormones Recruiting University College, London Phase 3 2006-03-01 RATIONALE: The increasingly prolonged and extended use of androgen deprivation therapy (ADT) in the treatment of prostate cancer, usually achieved through the administration of LHRH agonists, has raised concerns about long-term toxicities, in particular osteoporosis and adverse metabolic changes which may be associated with type II diabetes and increased cardiovascular risk. An alternative approach is to investigate other methods of ADT. Oral oestrogen has been shown to be as effective as LHRH and surgical orchidectomy in achieving castrate levels of testosterone and has equivalent or improved prostate cancer outcomes but is not used routinely as first-line therapy because of the risk of cardiovascular system (CVS) complications. The CVS complications have been attributed to first-pass hepatic metabolism. Administering oestrogen parenterally avoids the entero-hepatic circulation and so is expected to mitigate the risk of CVS toxicity whilst still effectively suppressing testosterone to castrate levels. This hypothesis has been supported by results from the early stages of this trial which have provided sufficient indication of the safety and efficacy of the patches to warrant further investigation of the treatment in this setting, as recommended by the IDMC.. PURPOSE: This randomized phase III trial is studying how well the estrogen skin patch works compared with luteinizing hormone-releasing hormone agonist injections in treating patients with locally advanced or metastatic prostate cancer.
NCT00303784 ↗ Prostate Adenocarcinoma TransCutaneous Hormones Recruiting Imperial College London Phase 3 2006-03-01 RATIONALE: The increasingly prolonged and extended use of androgen deprivation therapy (ADT) in the treatment of prostate cancer, usually achieved through the administration of LHRH agonists, has raised concerns about long-term toxicities, in particular osteoporosis and adverse metabolic changes which may be associated with type II diabetes and increased cardiovascular risk. An alternative approach is to investigate other methods of ADT. Oral oestrogen has been shown to be as effective as LHRH and surgical orchidectomy in achieving castrate levels of testosterone and has equivalent or improved prostate cancer outcomes but is not used routinely as first-line therapy because of the risk of cardiovascular system (CVS) complications. The CVS complications have been attributed to first-pass hepatic metabolism. Administering oestrogen parenterally avoids the entero-hepatic circulation and so is expected to mitigate the risk of CVS toxicity whilst still effectively suppressing testosterone to castrate levels. This hypothesis has been supported by results from the early stages of this trial which have provided sufficient indication of the safety and efficacy of the patches to warrant further investigation of the treatment in this setting, as recommended by the IDMC.. PURPOSE: This randomized phase III trial is studying how well the estrogen skin patch works compared with luteinizing hormone-releasing hormone agonist injections in treating patients with locally advanced or metastatic prostate cancer.
NCT00353496 ↗ Study of Lanreotide Autogel in Non-functioning Entero-pancreatic Endocrine Tumours Completed Ipsen Phase 3 2006-06-01 The study will compare the difference between lanreotide Autogel and placebo on progression free survival in patients who have an endocrine tumour in the pancreas or intestines.
NCT00494624 ↗ Efficacy of Systemic Glucocorticoid in the Treatment of Wheezing in Children Unknown status Academy of Finland Phase 4 2000-09-01 We can not predict which wheezing child younger than 3 years of age benefits from systemic glucocorticoid and which one does not. It is not known whether the differences in the efficacy are related to the differences in viral etiology, atopy, immunogical maturity or age of the patient. The study aims to answer the following questions: 1. What is the viral etiology of acute childhood expiratory wheezing? 2. What is the efficacy of prednisolone in relation to age, atopy and viral etiology in acute childhood wheezing? 3. Does prednisolone treatment increase risk for secundary bacterial infection in acute childhood expiratory wheezing? 4. What is the significance of inflammatory markers in predicting the efficacy of systemic steroid or patient outcome in acute childhood expiratory wheezing? Study will follow randomized, double blind, placebo-controlled parallel design. Study will start in Septemper 2000 and will be performed at the Department of Pediatrics, Turku University Hospital, Turku Finland. The study population will be 300 hospitalized wheezing children aged 3 months - 15 years. Investigational drug will be prednisolone, first dose 2 mg/kg, then 2 mg/kg/d/3 (max. 60 mg/vrk) p.o. for 3 d and comparative drug will be placebo tablet similar to investigational drug with the equal dosage. The primary outcome will be the time until ready for discharge. The study will provide new and important information for the diagnostics, treatment, disease outcome and prevention of acute childhood expiratory wheezing.
NCT00494624 ↗ Efficacy of Systemic Glucocorticoid in the Treatment of Wheezing in Children Unknown status University of Turku Phase 4 2000-09-01 We can not predict which wheezing child younger than 3 years of age benefits from systemic glucocorticoid and which one does not. It is not known whether the differences in the efficacy are related to the differences in viral etiology, atopy, immunogical maturity or age of the patient. The study aims to answer the following questions: 1. What is the viral etiology of acute childhood expiratory wheezing? 2. What is the efficacy of prednisolone in relation to age, atopy and viral etiology in acute childhood wheezing? 3. Does prednisolone treatment increase risk for secundary bacterial infection in acute childhood expiratory wheezing? 4. What is the significance of inflammatory markers in predicting the efficacy of systemic steroid or patient outcome in acute childhood expiratory wheezing? Study will follow randomized, double blind, placebo-controlled parallel design. Study will start in Septemper 2000 and will be performed at the Department of Pediatrics, Turku University Hospital, Turku Finland. The study population will be 300 hospitalized wheezing children aged 3 months - 15 years. Investigational drug will be prednisolone, first dose 2 mg/kg, then 2 mg/kg/d/3 (max. 60 mg/vrk) p.o. for 3 d and comparative drug will be placebo tablet similar to investigational drug with the equal dosage. The primary outcome will be the time until ready for discharge. The study will provide new and important information for the diagnostics, treatment, disease outcome and prevention of acute childhood expiratory wheezing.
NCT00683735 ↗ Quantification of the Dipeptidyl Peptidase (DPP)-4 Inhibition-mediated Enhancement of the Activity of the Entero-insular Axis Completed Michael A. Nauck Phase 2/Phase 3 2009-02-01 Objective: To assess the effect if co-administration of sitagliptin and metformin compared to placebo on the incretin effect (based on the comparison of the insulin secretory response to oral glucose load and an 'isoglycaemic' intravenous glucose load). Hypothesis: Treatment with co-administration of sitagliptin and metformin provides a greater incretin effect compared to placebo.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Entero Vu 24%

Condition Name

Condition Name for Entero Vu 24%
Intervention Trials
Neuroendocrine Tumors 7
Neuroendocrine Carcinoma 3
Pulmonary Disease, Chronic Obstructive 3
Gastroenteropancreatic Neuroendocrine Tumors 2
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Condition MeSH

Condition MeSH for Entero Vu 24%
Intervention Trials
Neuroendocrine Tumors 15
Carcinoid Tumor 9
Pancreatic Neoplasms 5
Adenoma, Islet Cell 5
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Clinical Trial Locations for Entero Vu 24%

Trials by Country

Trials by Country for Entero Vu 24%
Location Trials
United States 17
Italy 9
United Kingdom 5
France 5
Germany 4
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Trials by US State

Trials by US State for Entero Vu 24%
Location Trials
California 4
Maryland 3
Massachusetts 2
Texas 2
New York 2
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Clinical Trial Progress for Entero Vu 24%

Clinical Trial Phase

Clinical Trial Phase for Entero Vu 24%
Clinical Trial Phase Trials
Phase 4 3
Phase 3 3
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Entero Vu 24%
Clinical Trial Phase Trials
Completed 15
Recruiting 5
Not yet recruiting 4
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Clinical Trial Sponsors for Entero Vu 24%

Sponsor Name

Sponsor Name for Entero Vu 24%
Sponsor Trials
Ipsen 5
GlaxoSmithKline 3
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori 3
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Sponsor Type

Sponsor Type for Entero Vu 24%
Sponsor Trials
Other 43
Industry 9
NIH 1
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ENTERO VU 24%: Clinical Trials, Market Analysis, and Projections

Introduction

ENTERO VU 24% is a radiographic contrast agent indicated for use in small bowel radiographic examinations to visualize the gastrointestinal (GI) tract in adult patients. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials and Approval

ENTERO VU 24% was approved by the FDA through a New Drug Application (NDA) process. The supplemental new drug application (sNDA) dated July 31, 2019, was approved, allowing for its use in small bowel radiographic examinations[2].

Clinical trials for ENTERO VU 24% focused on its efficacy and safety in visualizing the GI tract. The drug has been shown to be effective in providing clear radiographic images of the small bowel, aiding in the diagnosis of various GI conditions. However, the trials also highlighted several contraindications and precautions, such as the risk of aspiration pneumonitis, barium sulfate impaction, and systemic embolization[1][4].

Market Analysis

Current Market Position

ENTERO VU 24% is part of the broader market for radiographic contrast agents, which is a segment within the diagnostic imaging industry. The demand for such agents is driven by the need for accurate and detailed imaging in diagnostic procedures.

Competitive Landscape

The market for radiographic contrast agents is competitive, with several other products available. However, ENTERO VU 24% has carved out a niche for itself in small bowel radiographic examinations. Its approval and specific indication have helped it gain traction among healthcare providers specializing in GI diagnostics[2].

Growth Trends

The diagnostic imaging market, including radiographic contrast agents, is expected to grow due to increasing healthcare needs and advancements in imaging technologies. The use of new modalities in the biopharmaceutical industry, as seen in the 2024 New Drug Modalities Report, indicates a broader trend towards innovative diagnostic tools, which could indirectly benefit the market for radiographic contrast agents like ENTERO VU 24%[3].

Projections

Market Size and Revenue

The market for radiographic contrast agents is projected to grow, driven by the increasing demand for diagnostic imaging. While specific revenue projections for ENTERO VU 24% are not available, the overall market is expected to see significant growth. For instance, the diagnostic imaging market as a whole is anticipated to expand due to technological advancements and increasing healthcare needs.

Future Developments

Future developments in the field of diagnostic imaging, including advancements in contrast agent technology, could impact the market position of ENTERO VU 24%. Innovations such as more targeted and safer contrast agents could potentially challenge its market share. However, ENTERO VU 24%’s established position and specific indication in small bowel radiography are likely to maintain its relevance in the market.

Safety and Efficacy Considerations

ENTERO VU 24% has several safety considerations that must be taken into account. These include the risk of aspiration pneumonitis, especially in patients with compromised swallowing mechanisms or a history of food aspiration. Other risks include barium sulfate impaction, intestinal perforation, and systemic embolization. Patients with hereditary fructose intolerance should also avoid this drug due to its sorbitol content[1][4].

Patient and Healthcare Provider Perspectives

From a patient perspective, ENTERO VU 24% offers a diagnostic tool that can provide clear and detailed images of the small bowel, aiding in the accurate diagnosis of GI conditions. However, patients must be aware of the potential risks and follow the prescribed hydration and monitoring protocols to minimize these risks.

Healthcare providers appreciate the specificity and efficacy of ENTERO VU 24% in small bowel radiography. The drug’s contraindications and precautions necessitate careful patient selection and monitoring, but its benefits in diagnostic accuracy make it a valuable tool in their practice.

Key Takeaways

  • Clinical Trials and Approval: ENTERO VU 24% was approved for use in small bowel radiographic examinations through an FDA-approved NDA process.
  • Market Analysis: The drug operates within a competitive market for radiographic contrast agents but has a niche in small bowel radiography.
  • Projections: The market for radiographic contrast agents is expected to grow, driven by increasing healthcare needs and technological advancements.
  • Safety and Efficacy: The drug has several safety considerations, including aspiration pneumonitis and barium sulfate impaction, which must be carefully managed.
  • Patient and Healthcare Provider Perspectives: Patients benefit from accurate diagnostic imaging, while healthcare providers value the drug’s specificity and efficacy in small bowel radiography.

FAQs

Q: What is ENTERO VU 24% used for? A: ENTERO VU 24% is used in small bowel radiographic examinations to visualize the gastrointestinal (GI) tract in adult patients.

Q: What are the contraindications for ENTERO VU 24%? A: The drug is contraindicated in patients with known or suspected perforation of the GI tract, high risk of GI perforation, trachea-esophageal fistula, and severe hypersensitivity to barium sulfate or its excipients[4].

Q: What are the potential risks associated with ENTERO VU 24%? A: Potential risks include aspiration pneumonitis, barium sulfate impaction, intestinal perforation, systemic embolization, and hypersensitivity reactions[1][4].

Q: How should patients prepare for and follow up after an ENTERO VU 24% procedure? A: Patients should maintain adequate hydration after the procedure to reduce the risk of delayed GI transit and obstruction. They should also be monitored closely for signs of aspiration or other adverse reactions[1][4].

Q: Is ENTERO VU 24% safe for patients with hereditary fructose intolerance? A: No, ENTERO VU 24% contains sorbitol and is not safe for patients with hereditary fructose intolerance due to the risk of severe symptoms such as vomiting, hypoglycemia, and kidney failure[4].

Sources

  1. DailyMed: ENTERO VU 24%- barium sulfate suspension - DailyMed
  2. FDA: ENTERO VU 24% - accessdata.fda.gov
  3. BCG: The 2024 New Drug Modalities Report | BCG
  4. Bracco: ENTERO VUTM (barium sulfate) oral suspension, 24% w/v - Bracco
Last updated: 2025-01-03

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