CLINICAL TRIALS PROFILE FOR OSMITROL 5% IN WATER

All Clinical Trials for Osmitrol 5% 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.

Clinical Trial Conditions for Osmitrol 5% In Water

Condition Name

Condition Name for Osmitrol 5% In Water
Intervention	Trials
Recurrent Adult Brain Neoplasm	2
Anaplastic Oligodendroglioma	1
Medulloepithelioma	1
Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor	1

Condition MeSH

Condition MeSH for Osmitrol 5% In Water
Intervention	Trials
Brain Neoplasms	2
Neuroectodermal Tumors	1
Syndrome	1
Lymphoma	1

Clinical Trial Locations for Osmitrol 5% In Water

Trials by Country

Trials by Country for Osmitrol 5% In Water
Location	Trials
United States	9
Australia	1

Trials by US State

Trials by US State for Osmitrol 5% In Water
Location	Trials
Oregon	3
Minnesota	3
Massachusetts	2
Ohio	1

Clinical Trial Progress for Osmitrol 5% In Water

Clinical Trial Phase

Clinical Trial Phase for Osmitrol 5% 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 5% In Water
Clinical Trial Phase	Trials
Completed	3
Active, not recruiting	2
Withdrawn	1

Clinical Trial Sponsors for Osmitrol 5% In Water

Sponsor Name

Sponsor Name for Osmitrol 5% 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 5% In Water
Sponsor	Trials
Other	9
NIH	4
Industry	3

OSMITROL (Mannitol Injection): Clinical Trials, Market Analysis, and Projections

Introduction

OSMITROL, a mannitol injection, is a widely used osmotic diuretic in clinical settings. It is employed for various medical indications, including the promotion of diuresis, reduction of intracranial and intraocular pressure, and the treatment of acute renal failure. Here, we will delve into the clinical trials, market analysis, and projections for OSMITROL.

Clinical Indications and Usage

OSMITROL is indicated for several clinical purposes:

• Promotion of Diuresis: It is used to prevent and treat the oliguric phase of acute renal failure and to promote the urinary excretion of toxic substances[2][4][5].
• Reduction of Intracranial Pressure: A dose of 0.25 g/kg is typically used to achieve maximum reduction in intracranial pressure[2][4][5].
• Reduction of Intraocular Pressure: A dose of 1.5 to 2 g/kg is administered intravenously to reduce intraocular pressure, especially preoperatively[2][4][5].

Clinical Trials and Efficacy

While specific recent clinical trials on OSMITROL 5% in water may not be extensively documented, the efficacy of mannitol in its various concentrations has been well-established through numerous studies. Mannitol's osmotic effect helps in reducing intracranial and intraocular pressures, and it is effective in promoting diuresis in patients with acute renal failure[2][4][5].

Safety and Monitoring

Clinical trials and usage guidelines emphasize the importance of monitoring patients closely during OSMITROL administration. This includes monitoring fluid and electrolyte status, serum osmolarity, and renal function to prevent complications such as osmotic nephrosis, hypernatremia, hyponatremia, and other electrolyte imbalances[1][2][5].

Market Analysis

Current Market

The market for osmotic diuretics like OSMITROL is part of the broader pharmaceutical market, particularly within the segment of critical care and emergency medications. The demand for these medications is driven by the need for effective treatments in acute care settings.

Market Projections

While specific market projections for OSMITROL 5% in water are not available, the overall market for osmotic diuretics is expected to grow due to several factors:

• Increasing Healthcare Needs: The growing need for critical care services and the management of acute conditions such as renal failure and increased intracranial pressure will drive the demand for osmotic diuretics[2][4].
• Technological Advancements: Advances in healthcare technology, including better monitoring systems and more precise dosing mechanisms, will enhance the safety and efficacy of mannitol administration[3].

Technological and Regulatory Trends

Virtual Clinical Trials

The COVID-19 pandemic has accelerated the adoption of virtual clinical trials, which could impact the future development and testing of medications like OSMITROL. Virtual trials can enhance patient recruitment, reduce costs, and speed up the trial process, potentially leading to faster market entry for new formulations or indications[3].

Regulatory Considerations

Regulatory bodies such as the FDA and Medsafe in New Zealand have strict guidelines for the use of OSMITROL, emphasizing the need for careful patient monitoring and the avoidance of contraindicated conditions such as severe renal disease and pulmonary edema[1][2][4].

Potential Risks and Complications

Fluid and Electrolyte Imbalances

Mannitol administration can lead to significant fluid and electrolyte imbalances, including hypernatremia, hyponatremia, and hypo/hyperkalemia. These imbalances can be severe and potentially fatal if not monitored and managed properly[1][2][5].

Renal Function

Patients with pre-existing renal disease are at increased risk of renal failure following OSMITROL administration. Close monitoring of renal function and serum osmolarity is crucial to prevent osmotic nephrosis and other renal complications[1][2][4].

Key Takeaways

• Clinical Indications: OSMITROL is used for promoting diuresis, reducing intracranial and intraocular pressure, and treating acute renal failure.
• Efficacy and Safety: The drug is effective but requires close monitoring to prevent fluid and electrolyte imbalances and renal complications.
• Market Projections: The market for osmotic diuretics is expected to grow driven by increasing healthcare needs and technological advancements.
• Regulatory Trends: Virtual clinical trials and strict regulatory guidelines will shape the future of OSMITROL and similar medications.

FAQs

What are the primary clinical indications for OSMITROL?

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

What are the potential risks associated with OSMITROL administration?

Potential risks include fluid and electrolyte imbalances, renal complications such as osmotic nephrosis, and exacerbation of conditions like congestive heart failure and pulmonary edema.

How is OSMITROL administered?

OSMITROL is administered intravenously, with the dosage and concentration adjusted based on the patient's condition, fluid requirements, and urinary output.

What monitoring is required during OSMITROL administration?

Close monitoring of fluid and electrolyte status, serum osmolarity, and renal function is essential to prevent complications.

Can OSMITROL be used in patients with renal disease?

OSMITROL should be used with caution in patients with impaired renal function, and its administration should be avoided in patients with severe renal disease until volume and electrolytes have been restored.

Sources

1. OSMITROL (mannitol injection), for intravenous use - FDA Label[1].
2. OSMITROL Injection (Mannitol Injection, USP) - FDA Label[2].
3. Virtual Clinical Trials Market Size And Share Report, 2030 - Grand View Research[3].
4. NEW ZEALAND DATA SHEET - Osmitrol infusion solution - Medsafe[4].
5. OSMITROL- mannitol injection, solution - DailyMed[5].

Last updated: 2025-01-05