CLINICAL TRIALS PROFILE FOR OSMITROL 10% IN WATER

All Clinical Trials for Osmitrol 10% In Water

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.
NCT00983398 ↗	Melphalan, Carboplatin, Mannitol, and Sodium Thiosulfate in Treating Patients With Recurrent or Progressive CNS Embryonal or Germ Cell Tumors	Active, not recruiting	National Cancer Institute (NCI)	Phase 1/Phase 2	2009-07-09	This phase I/II trial studies the side effects and best dose of melphalan when given together with carboplatin, mannitol, and sodium thiosulfate, and to see how well they work in treating patients with central nervous system (CNS) embryonal or germ cell tumors that is growing, spreading, or getting worse (progressive) or has come back (recurrent). Drugs used in chemotherapy, such as melphalan and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, 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 melphalan together with carboplatin, mannitol, and sodium thiosulfate may be an effective treatment for recurrent or progressive CNS embryonal or germ cell tumors.

Clinical Trial Conditions for Osmitrol 10% In Water

Condition Name

Condition Name for Osmitrol 10% In Water
Intervention	Trials
Recurrent Adult Brain Neoplasm	2
Mixed Glioma	1
Adult Anaplastic Oligodendroglioma	1
Recurrent Malignant Germ Cell Tumor	1

Condition MeSH

Condition MeSH for Osmitrol 10% In Water
Intervention	Trials
Brain Neoplasms	2
Neuroectodermal Tumors	1
Syndrome	1
Lymphoma	1

Clinical Trial Locations for Osmitrol 10% In Water

Trials by Country

Trials by Country for Osmitrol 10% In Water
Location	Trials
United States	9
Australia	1

Trials by US State

Trials by US State for Osmitrol 10% In Water
Location	Trials
Oregon	3
Minnesota	3
Massachusetts	2
Ohio	1

Clinical Trial Progress for Osmitrol 10% In Water

Clinical Trial Phase

Clinical Trial Phase for Osmitrol 10% In Water
Clinical Trial Phase	Trials
Phase 1/Phase 2	4
Phase 1	1
N/A	1

Clinical Trial Status

Clinical Trial Status for Osmitrol 10% In Water
Clinical Trial Phase	Trials
Completed	3
Active, not recruiting	2
Withdrawn	1

Clinical Trial Sponsors for Osmitrol 10% In Water

Sponsor Name

Sponsor Name for Osmitrol 10% In Water
Sponsor	Trials
National Cancer Institute (NCI)	3
Oregon Health and Science University	3
OHSU Knight Cancer Institute	3

Sponsor Type

Sponsor Type for Osmitrol 10% In Water
Sponsor	Trials
Other	9
NIH	4
Industry	3

OSMITROL 10% in Water: Clinical Trials, Market Analysis, and Projections

Introduction

OSMITROL 10% in water, a solution of mannitol, is a widely used osmotic diuretic in medical practice. This article will delve into the clinical trials, market analysis, and projections for this drug, providing a comprehensive overview of its significance and future outlook.

Clinical Indications and Uses

OSMITROL 10% is indicated for several clinical purposes, including the promotion of diuresis, prevention and treatment of the oliguric phase of acute renal failure, and the reduction of intraocular pressure and intracranial pressure[2].

Promotion of Diuresis

It is used to promote diuresis in patients with oliguria, which is the low output of urine. The usual dose for this purpose can range from 50 to 100 grams of mannitol as a 10% or 20% solution, depending on the patient's fluid requirements[1].

Prevention and Treatment of Acute Renal Failure

During cardiovascular and other types of surgery, OSMITROL 10% can be administered to prevent acute renal failure. The dose typically ranges from 50 to 100 grams[1].

Reduction of Intraocular and Intracranial Pressure

For reducing elevated intraocular pressure, a dose of 1.5 to 2.0 grams/kg as a 20% solution can be administered over a short period, such as 30 minutes[1].

Pharmacokinetics and Pharmacodynamics

Mannitol, the active ingredient in OSMITROL 10%, is freely filtered by the renal glomeruli and is poorly reabsorbed by the renal tubules. It is not secreted by tubular cells and is pharmacologically inert. Approximately 80% of an intravenous dose is excreted unchanged within three hours, with an elimination half-life of about 2 hours in adults, which can be longer in cases of renal failure[2].

Clinical Trials and Safety Data

Clinical Trials

While specific recent clinical trials focused solely on OSMITROL 10% are not widely documented, the drug's efficacy and safety have been well-established through numerous studies over the years. These studies have confirmed its role as an effective osmotic diuretic.

Safety Data

Mannitol administration can lead to significant electrolyte and fluid imbalances, including hypernatremia, dehydration, and haemoconcentration. It is crucial to monitor serum sodium and potassium levels and ensure that patients are not in shock or have untreated renal dysfunction before administering the drug[1].

Market Analysis

Current Market

The market for osmotic diuretics, including OSMITROL 10%, is part of the broader pharmaceutical market. While specific market data for OSMITROL 10% is not readily available, the overall pharmacovigilance market, which includes drugs like mannitol, is significant. The global pharmacovigilance market was estimated at USD 7.32 billion in 2023 and is expected to grow at a CAGR of 6.8% from 2024 to 2030[3].

Market Projections

Given the essential role of osmotic diuretics in clinical practice, the demand for OSMITROL 10% is expected to remain steady. Factors such as increasing healthcare expenditure, growing awareness of drug safety, and advancements in clinical trial management are likely to support the market growth.

Regional Outlook

Regions with high healthcare spending and advanced medical infrastructure, such as the United States and Japan, are expected to drive the market. For instance, Japan's pharmacovigilance market is anticipated to grow significantly due to high drug consumption and chronic disease prevalence[3].

Competitive Landscape

The market for osmotic diuretics is competitive, with several manufacturers producing mannitol solutions. Companies like Baxter Healthcare, which produces OSMITROL, play a significant role in this market. The competitive landscape is driven by factors such as product quality, pricing, and regulatory compliance.

Regulatory Considerations

OSMITROL 10% must comply with stringent regulatory requirements. The FDA and other regulatory bodies ensure that the drug meets safety and efficacy standards. For example, the FDA label for OSMITROL Injection outlines its indications, dosage, and potential side effects in detail[2].

Future Outlook

Technological Advancements

Advancements in drug delivery systems and clinical trial technologies are expected to enhance the efficacy and safety profile of OSMITROL 10%. For instance, better monitoring systems and more precise dosing mechanisms could improve patient outcomes.

Increasing Demand

The growing need for effective diuretics in various clinical settings, coupled with an aging population and increasing incidence of chronic diseases, is likely to drive the demand for OSMITROL 10%.

Challenges and Opportunities

Despite its established use, OSMITROL 10% faces challenges such as the potential for electrolyte imbalances and the need for careful patient monitoring. However, these challenges also present opportunities for innovation in patient care and drug administration.

"Mannitol is an obligatory osmotic diuretic. It is freely filterable at the renal glomerulus, is poorly reabsorbed by the renal tubule, is not secreted by the tubule, and is pharmacologically inert."[1]

Key Takeaways

• Clinical Indications: OSMITROL 10% is used for promoting diuresis, preventing and treating acute renal failure, and reducing intraocular and intracranial pressure.
• Pharmacokinetics: Mannitol is freely filtered by the kidneys and excreted largely unchanged.
• Market Analysis: The market for osmotic diuretics is part of the broader pharmacovigilance market, expected to grow at a CAGR of 6.8% from 2024 to 2030.
• Regulatory Compliance: The drug must meet stringent FDA and other regulatory standards.
• Future Outlook: Technological advancements and increasing demand are expected to drive the market, despite challenges related to patient monitoring.

FAQs

What are the primary clinical indications for OSMITROL 10%?

OSMITROL 10% is indicated for promoting diuresis, preventing and treating the oliguric phase of acute renal failure, and reducing intraocular and intracranial pressure.

How is mannitol metabolized in the body?

Mannitol is metabolically inert in humans and is eliminated largely unmetabolized through the kidneys.

What are the potential side effects of OSMITROL 10%?

Potential side effects include electrolyte imbalances, dehydration, haemoconcentration, and vein damage from hypertonic solutions.

What is the expected market growth for osmotic diuretics like OSMITROL 10%?

The market is expected to grow at a CAGR of 6.8% from 2024 to 2030, driven by increasing healthcare expenditure and advancements in clinical trial management.

Why is careful patient monitoring necessary when administering OSMITROL 10%?

Careful monitoring is necessary to prevent and manage potential electrolyte imbalances, dehydration, and other complications associated with mannitol administration.

Sources

1. Medsafe. NEW ZEALAND DATA SHEET - Osmitrol (solution for infusion)[1].
2. FDA. OSMITROL Injection (Mannitol Injection, USP)[2].
3. Grand View Research. Pharmacovigilance Market Size, Share, Trends Report 2030[3].
4. FDA. 22368Orig1s000 - Osmitrol 10% solution[4].
5. PubChem. Mannitol | C6H14O6 | CID 6251[5].