CLINICAL TRIALS PROFILE FOR OSMITROL 20% IN WATER

All Clinical Trials for Osmitrol 20% 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 20% In Water

Condition Name

Condition Name for Osmitrol 20% In Water
Intervention	Trials
Recurrent Adult Brain Neoplasm	2
Embryonal Tumor With Multilayered Rosettes, C19MC-Altered	1
Recurrent Childhood Malignant Germ Cell Tumor	1
Adult Supratentorial Primitive Neuroectodermal Tumor	1

Condition MeSH

Condition MeSH for Osmitrol 20% In Water
Intervention	Trials
Brain Neoplasms	2
Pinealoma	1
Pneumonia	1
Glioma	1

Clinical Trial Locations for Osmitrol 20% In Water

Trials by Country

Trials by Country for Osmitrol 20% In Water
Location	Trials
United States	9
Australia	1

Trials by US State

Trials by US State for Osmitrol 20% In Water
Location	Trials
Oregon	3
Minnesota	3
Massachusetts	2
Ohio	1

Clinical Trial Progress for Osmitrol 20% In Water

Clinical Trial Phase

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Withdrawn	1

Clinical Trial Sponsors for Osmitrol 20% In Water

Sponsor Name

Sponsor Name for Osmitrol 20% 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 20% In Water
Sponsor	Trials
Other	9
NIH	4
Industry	3

OSMITROL 20% in Water: Clinical Trials, Market Analysis, and Projections

Introduction

OSMITROL, a solution of mannitol, is widely used as an osmotic diuretic for various medical applications, including the reduction of intracranial and intraocular pressure, promotion of diuresis, and prevention of acute renal failure. Here, we delve into the clinical trials, market analysis, and future projections for OSMITROL 20% in water.

Clinical Trials and Efficacy

Comparison with Other Osmotic Stimulants

Clinical trials have compared the efficacy of 20% mannitol with 5% saline as osmotic stimulants. A study involving healthy volunteers showed that 5% saline infusion stimulated higher levels of plasma osmolality, vasopressin, and thirst compared to 20% mannitol. However, both solutions had similar thresholds for vasopressin release and thirst onset, indicating that mannitol can be an effective alternative in certain clinical scenarios[1].

Therapeutic Indications

OSMITROL 20% is used in several therapeutic contexts:

• Reduction of Intracranial Pressure: A dose of 0.25 gram/kg administered intravenously over 30 minutes can achieve significant reduction in intracranial pressure[4][5].
• Reduction of Intraocular Pressure: A dose of 1.5 to 2 grams/kg as a 20% solution can be administered over 30 minutes to reduce intraocular pressure[4][5].
• Promotion of Diuresis: Used to treat oliguria and prevent acute renal failure, especially during surgeries[2][5].

Safety and Monitoring

Adverse Reactions and Complications

The administration of OSMITROL 20% can lead to several adverse reactions, including:

• Electrolyte Imbalances: Hypernatremia, hyponatremia, hypo/hyperkalemia, and other electrolyte disturbances can occur due to osmotic diuresis[4][5].
• Renal Complications: Patients are at risk of reversible or irreversible renal failure, especially those with pre-existing renal disease or those receiving nephrotoxic drugs[4][5].
• Fluid and Electrolyte Imbalances: Mannitol-induced diuresis can cause dehydration, hypovolemia, and hemoconcentration[4][5].

Monitoring Requirements

Close monitoring of fluid and electrolyte status, serum osmolarity, and renal, cardiac, and pulmonary function is crucial during and after OSMITROL infusion. Discontinuation of the drug is recommended if any adverse reactions or imbalances occur[4][5].

Market Analysis

Market Size and Growth

The global mannitol market, which includes OSMITROL 20%, was valued at USD 398.62 million in 2022 and is projected to reach USD 584.47 million by 2030, growing at a CAGR of 4.9%. The 20g/100 ml concentration is expected to represent the largest revenue segment due to its widespread use in treating conditions such as increased intracranial pressure, glaucoma, and advanced diuresis in patients with renal failure[3].

Market Segmentation

The market is segmented based on item type (concentration of mannitol) and application. The 20% concentration is particularly significant for its use in critical care settings, such as reducing intracranial and intraocular pressure, and promoting diuresis in patients with renal issues[3].

Projections and Future Outlook

Increasing Demand

The demand for OSMITROL 20% is expected to rise due to its efficacy in managing acute conditions that require rapid reduction in intracranial and intraocular pressure. The growing incidence of neurological and ophthalmological disorders will drive the market growth[3].

Technological Advancements

Advancements in medical technology and the development of more precise dosing regimens are likely to enhance the safety and efficacy of OSMITROL 20%. Improved monitoring tools and better understanding of patient responses will also contribute to its increased adoption[4][5].

Regulatory Considerations

Regulatory bodies will continue to play a crucial role in ensuring the safe use of OSMITROL 20%. Strict guidelines and monitoring requirements will be enforced to mitigate the risks associated with its administration, particularly in patients with compromised renal function[4][5].

Key Takeaways

• Efficacy: OSMITROL 20% is effective in reducing intracranial and intraocular pressure and promoting diuresis.
• Safety: Close monitoring is essential to manage potential adverse reactions, including electrolyte imbalances and renal complications.
• Market Growth: The global mannitol market, including OSMITROL 20%, is projected to grow at a CAGR of 4.9% until 2030.
• Future Outlook: Increasing demand, technological advancements, and regulatory oversight will shape the future of OSMITROL 20%.

FAQs

What are the primary therapeutic indications for OSMITROL 20%?

OSMITROL 20% is primarily used to reduce intracranial and intraocular pressure, promote diuresis, and prevent acute renal failure.

What are the potential adverse reactions associated with OSMITROL 20%?

Potential adverse reactions include electrolyte imbalances, renal complications, fluid and electrolyte imbalances, and CNS toxicity.

How should patients be monitored during OSMITROL 20% infusion?

Patients should be closely monitored for fluid and electrolyte status, serum osmolarity, and renal, cardiac, and pulmonary function.

What is the projected market growth for the mannitol market, including OSMITROL 20%?

The global mannitol market is expected to grow at a CAGR of 4.9% until 2030, reaching USD 584.47 million.

Can OSMITROL 20% be administered in patients with renal dysfunction?

OSMITROL 20% should not be administered in patients with renal dysfunction until volume and electrolytes have been restored, and close monitoring is required to avoid further renal impairment.

Sources

1. Comparison of 20% mannitol with 5% saline as osmotic stimulants in normal volunteers - PubMed
2. NEW ZEALAND DATA SHEET - Medsafe
3. Mannitol Market Size & Share Report Forecast 2023-2030 - SNS Insider
4. OSMITROL (mannitol injection), for intravenous use - FDA
5. OSMITROL- mannitol injection, solution - DailyMed