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Last Updated: February 8, 2025

CLINICAL TRIALS PROFILE FOR OSMITROL 20% IN WATER IN PLASTIC CONTAINER


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All Clinical Trials for Osmitrol 20% In Water In Plastic Container

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00293475 ↗ Methotrexate, Mannitol, Rituximab, and Carboplatin in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma Active, not recruiting National Cancer Institute (NCI) Phase 1/Phase 2 2005-10-14 This phase I/II trial studies the side effects of methotrexate, mannitol, rituximab, and carboplatin and to see how well they work in treating patients with primary central nervous system lymphoma. Drugs used in chemotherapy, such as methotrexate and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Osmotic blood-brain barrier disruption uses mannitol to open the blood vessels around the brain and allow cancer-killing substances to be carried directly to the brain. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Giving methotrexate, mannitol, rituximab, and carboplatin together may be an effective treatment for primary central nervous system lymphoma.
NCT00293475 ↗ Methotrexate, Mannitol, Rituximab, and Carboplatin in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma Active, not recruiting Oregon Health and Science University Phase 1/Phase 2 2005-10-14 This phase I/II trial studies the side effects of methotrexate, mannitol, rituximab, and carboplatin and to see how well they work in treating patients with primary central nervous system lymphoma. Drugs used in chemotherapy, such as methotrexate and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Osmotic blood-brain barrier disruption uses mannitol to open the blood vessels around the brain and allow cancer-killing substances to be carried directly to the brain. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Giving methotrexate, mannitol, rituximab, and carboplatin together may be an effective treatment for primary central nervous system lymphoma.
NCT00293475 ↗ Methotrexate, Mannitol, Rituximab, and Carboplatin in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma Active, not recruiting OHSU Knight Cancer Institute Phase 1/Phase 2 2005-10-14 This phase I/II trial studies the side effects of methotrexate, mannitol, rituximab, and carboplatin and to see how well they work in treating patients with primary central nervous system lymphoma. Drugs used in chemotherapy, such as methotrexate and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Osmotic blood-brain barrier disruption uses mannitol to open the blood vessels around the brain and allow cancer-killing substances to be carried directly to the brain. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Giving methotrexate, mannitol, rituximab, and carboplatin together may be an effective treatment for primary central nervous system lymphoma.
NCT00303849 ↗ Carboplatin, Melphalan, Etoposide Phosphate, Mannitol, and Sodium Thiosulfate in Treating Patients With Previously Treated Brain Tumors Completed National Cancer Institute (NCI) Phase 1/Phase 2 2005-09-15 This phase I/II trial studies the side effects and best dose of melphalan when given together with carboplatin, etoposide phosphate, mannitol, and sodium thiosulfate and to see how well they work in treating patients with previously treated brain tumors. Drugs used in chemotherapy, such as melphalan, carboplatin, and etoposide phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing, or by stopping them from spreading. Osmotic blood-brain barrier disruption (BBBD) uses mannitol to open the blood vessels around the brain and allow cancer-killing substances to be carried directly to the brain. Sodium thiosulfate may help lessen or prevent hearing loss and toxicities in patients undergoing chemotherapy with carboplatin and BBBD. Giving carboplatin, melphalan, etoposide phosphate, mannitol, and sodium thiosulfate together may be an effective treatment for brain tumors.
NCT00303849 ↗ Carboplatin, Melphalan, Etoposide Phosphate, Mannitol, and Sodium Thiosulfate in Treating Patients With Previously Treated Brain Tumors Completed Oregon Health and Science University Phase 1/Phase 2 2005-09-15 This phase I/II trial studies the side effects and best dose of melphalan when given together with carboplatin, etoposide phosphate, mannitol, and sodium thiosulfate and to see how well they work in treating patients with previously treated brain tumors. Drugs used in chemotherapy, such as melphalan, carboplatin, and etoposide phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing, or by stopping them from spreading. Osmotic blood-brain barrier disruption (BBBD) uses mannitol to open the blood vessels around the brain and allow cancer-killing substances to be carried directly to the brain. Sodium thiosulfate may help lessen or prevent hearing loss and toxicities in patients undergoing chemotherapy with carboplatin and BBBD. Giving carboplatin, melphalan, etoposide phosphate, mannitol, and sodium thiosulfate together may be an effective treatment for brain tumors.
NCT00303849 ↗ Carboplatin, Melphalan, Etoposide Phosphate, Mannitol, and Sodium Thiosulfate in Treating Patients With Previously Treated Brain Tumors Completed OHSU Knight Cancer Institute Phase 1/Phase 2 2005-09-15 This phase I/II trial studies the side effects and best dose of melphalan when given together with carboplatin, etoposide phosphate, mannitol, and sodium thiosulfate and to see how well they work in treating patients with previously treated brain tumors. Drugs used in chemotherapy, such as melphalan, carboplatin, and etoposide phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing, or by stopping them from spreading. Osmotic blood-brain barrier disruption (BBBD) uses mannitol to open the blood vessels around the brain and allow cancer-killing substances to be carried directly to the brain. Sodium thiosulfate may help lessen or prevent hearing loss and toxicities in patients undergoing chemotherapy with carboplatin and BBBD. Giving carboplatin, melphalan, etoposide phosphate, mannitol, and sodium thiosulfate together may be an effective treatment for brain tumors.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Osmitrol 20% In Water In Plastic Container

Condition Name

Condition Name for Osmitrol 20% In Water In Plastic Container
Intervention Trials
Recurrent Adult Brain Neoplasm 2
Adult Oligodendroglioma 1
Elevated Intracranial Pressure 1
Recurrent Childhood Central Nervous System Embryonal Neoplasm 1
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Condition MeSH

Condition MeSH for Osmitrol 20% In Water In Plastic Container
Intervention Trials
Brain Neoplasms 2
Medulloblastoma 1
Rhabdoid Tumor 1
Oligodendroglioma 1
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Clinical Trial Locations for Osmitrol 20% In Water In Plastic Container

Trials by Country

Trials by Country for Osmitrol 20% In Water In Plastic Container
Location Trials
United States 9
Australia 1
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Trials by US State

Trials by US State for Osmitrol 20% In Water In Plastic Container
Location Trials
Oregon 3
Minnesota 3
Massachusetts 2
Ohio 1
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Clinical Trial Progress for Osmitrol 20% In Water In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Osmitrol 20% In Water In Plastic Container
Clinical Trial Phase Trials
Phase 1/Phase 2 4
Phase 1 1
N/A 1
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Clinical Trial Status

Clinical Trial Status for Osmitrol 20% In Water In Plastic Container
Clinical Trial Phase Trials
Completed 3
Active, not recruiting 2
Withdrawn 1
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Clinical Trial Sponsors for Osmitrol 20% In Water In Plastic Container

Sponsor Name

Sponsor Name for Osmitrol 20% In Water In Plastic Container
Sponsor Trials
National Cancer Institute (NCI) 3
Oregon Health and Science University 3
OHSU Knight Cancer Institute 3
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Sponsor Type

Sponsor Type for Osmitrol 20% In Water In Plastic Container
Sponsor Trials
Other 9
NIH 4
Industry 3
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OSMITROL 20% in Water: Clinical Trials, Market Analysis, and Projections

Introduction

OSMITROL, a 20% mannitol solution, is a widely used medical agent approved by the FDA for various clinical applications, including the reduction of intracranial and intraocular pressure, diuresis, and the preservation of blood components. Here, we delve into the current state of clinical trials, market analysis, and future projections for OSMITROL 20% in water.

Clinical Uses of OSMITROL 20%

OSMITROL 20% is utilized in several critical medical scenarios:

  • Reduction of Intracranial Pressure: It is administered intravenously to reduce intracranial pressure, particularly in cases of cerebral edema or traumatic brain injury[2].
  • Reduction of Intraocular Pressure: Used preoperatively to manage increased intraocular pressure before eye surgery[2].
  • Diuresis: Helps in inducing diuresis, especially in patients with acute kidney failure[1][2].
  • Preservation of Blood Components: Used in the collection, processing, and preservation of blood components[1].

Current Clinical Trials

Several clinical trials are ongoing to explore the efficacy and safety of OSMITROL 20% in various conditions:

  • Brain and Kidney Failure: Active trials are investigating the use of mannitol 20% in managing symptoms associated with brain injuries and acute kidney failure[1].
  • Diuresis and Glaucoma: Trials are also focused on its effectiveness in inducing diuresis and managing glaucoma by reducing intraocular pressure[1].
  • Cystic Fibrosis: There is an ongoing trial examining the potential benefits of mannitol 20% in patients with cystic fibrosis[1].

These trials aim to expand the therapeutic applications of OSMITROL 20% and provide more robust data on its efficacy and safety profile.

Dosage and Administration

The dosage of OSMITROL 20% varies based on the clinical condition being treated:

  • Intracranial Pressure: Typically, 0.25 gram/kg is administered intravenously over 30 minutes, which may be repeated every six to eight hours[2].
  • Intraocular Pressure: A single dose of 1.5 to 2 grams/kg is administered intravenously over at least 30 minutes, preferably sixty to ninety minutes before surgery[2].

Monitoring of fluid and electrolyte balance, serum osmolarity, and renal, cardiac, and pulmonary function is crucial during and after the infusion[2].

Market Analysis

Global Market Size and Growth

While OSMITROL 20% itself is not a standalone market, it is part of the broader osmotic and hypertonic solutions market. The global market for osmotic pumps, which can be related in terms of controlled drug delivery systems, is projected to grow significantly:

  • The global osmotic pumps market was valued at USD 7.80 billion in 2023 and is expected to reach USD 8.37 billion by 2032, growing at a CAGR of 7.9% during the forecast period (2024-2032)[5].

Regional Market Dynamics

  • North America: This region is the largest market shareholder due to advanced healthcare infrastructure, high healthcare expenditure, and technological advancements. It is expected to expand substantially during the forecast period[5].
  • Asia Pacific: This region is the fastest-growing market, driven by increasing healthcare investments and the adoption of advanced medical technologies[5].

Market Drivers and Barriers

  • Drivers: The growing need for effective drug delivery systems, especially for chronic disorders, advancements in drug formulation and pump design, and the trend towards personalized medicine are driving the market growth[5].
  • Barriers: High costs and stringent regulatory procedures are significant barriers, although the overall outlook remains positive with enormous growth opportunities, particularly in oncology and biologics drug delivery[5].

Projections and Future Outlook

Given the ongoing clinical trials and the expanding applications of OSMITROL 20%, here are some key projections:

  • Increased Adoption: As clinical trials yield positive results, the adoption of OSMITROL 20% is expected to increase across various medical specialties.
  • Technological Advancements: Improvements in drug delivery systems, such as osmotic pumps, will enhance the efficacy and safety profile of OSMITROL 20%, making it a preferred choice for long-term therapy.
  • Market Expansion: The market for osmotic and hypertonic solutions is likely to grow, driven by the increasing demand for controlled and effective drug delivery systems, particularly in regions like Asia-Pacific and Latin America[5].

Key Takeaways

  • OSMITROL 20% is a versatile medical agent with multiple FDA-approved uses.
  • Ongoing clinical trials are exploring its potential in new therapeutic areas.
  • The market for related drug delivery systems is growing, driven by technological advancements and increasing healthcare investments.
  • North America and Asia-Pacific are key regions driving market growth.

FAQs

What are the primary uses of OSMITROL 20%?

OSMITROL 20% is primarily used to reduce intracranial and intraocular pressure, induce diuresis, and in the preservation of blood components.

What are the current clinical trials focusing on?

Current trials are investigating the use of OSMITROL 20% in managing brain injuries, acute kidney failure, cystic fibrosis, and glaucoma.

How is OSMITROL 20% administered?

The dosage and administration vary based on the condition being treated, typically involving intravenous infusion over a specified period, with careful monitoring of fluid and electrolyte balance.

What is the market outlook for OSMITROL 20% and related drug delivery systems?

The market is expected to grow, driven by advancements in drug delivery systems and increasing healthcare investments, particularly in North America and Asia-Pacific.

What are the main drivers and barriers in the market for osmotic pumps and related solutions?

Drivers include the need for effective drug delivery systems, technological advancements, and personalized medicine. Barriers include high costs and stringent regulatory procedures.

How does the use of OSMITROL 20% impact patient care?

It provides a controlled and effective way to manage critical medical conditions, improving patient outcomes by reducing intracranial and intraocular pressure, inducing diuresis, and preserving blood components.

Sources

  1. Withpower.com: Mannitol 20%: Everything you need to know | Power - Clinical Trials
  2. DailyMed.nlm.nih.gov: Label: OSMITROL- mannitol injection, solution - DailyMed
  3. VWR.com: Mannitol solution 20% in water, Osmitrol® USP for injection
  4. Jamanetwork.com: Effect of Continuous Infusion of Hypertonic Saline vs Standard Care ...
  5. Straitsresearch.com: Osmotic Pumps Market Size, Top Share, Demand, Forecast to 2032

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