CLINICAL TRIALS PROFILE FOR OSMITROL 15% IN WATER IN PLASTIC CONTAINER

All Clinical Trials for Osmitrol 15% 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.

Clinical Trial Conditions for Osmitrol 15% In Water In Plastic Container

Condition Name

Condition Name for Osmitrol 15% In Water In Plastic Container
Intervention	Trials
Recurrent Adult Brain Neoplasm	2
Adult Medulloblastoma	1
Childhood Ependymoblastoma	1
Pulmonary Inflammation	1

Condition MeSH

Condition MeSH for Osmitrol 15% In Water In Plastic Container
Intervention	Trials
Brain Neoplasms	2
Pinealoma	1
Pneumonia	1
Glioma	1

Clinical Trial Locations for Osmitrol 15% In Water In Plastic Container

Trials by Country

Trials by Country for Osmitrol 15% In Water In Plastic Container
Location	Trials
United States	9
Australia	1

Trials by US State

Trials by US State for Osmitrol 15% In Water In Plastic Container
Location	Trials
Oregon	3
Minnesota	3
Massachusetts	2
Ohio	1

Clinical Trial Progress for Osmitrol 15% In Water In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Osmitrol 15% In Water In Plastic Container
Clinical Trial Phase	Trials
Phase 1/Phase 2	4
Phase 1	1
N/A	1

Clinical Trial Status

Clinical Trial Status for Osmitrol 15% In Water In Plastic Container
Clinical Trial Phase	Trials
Completed	3
Active, not recruiting	2
Withdrawn	1

Clinical Trial Sponsors for Osmitrol 15% In Water In Plastic Container

Sponsor Name

Sponsor Name for Osmitrol 15% In Water In Plastic Container
Sponsor	Trials
National Cancer Institute (NCI)	3
Oregon Health and Science University	3
OHSU Knight Cancer Institute	3

Sponsor Type

Sponsor Type for Osmitrol 15% In Water In Plastic Container
Sponsor	Trials
Other	9
NIH	4
Industry	3

OSMITROL 15% IN WATER IN PLASTIC CONTAINER: Clinical Trials, Market Analysis, and Projections

Introduction to OSMITROL

OSMITROL Injection (Mannitol Injection, USP) is a sterile, nonpyrogenic solution of mannitol, a six-carbon sugar alcohol, used for intravenous administration. It is an obligatory osmotic diuretic, freely filterable at the renal glomerulus and poorly reabsorbed by the renal tubule, making it pharmacologically inert in humans[1][3].

Clinical Trials and Usage

Indications and Clinical Use

OSMITROL Injection is indicated for several clinical uses:

• Promotion of diuresis in the prevention and/or treatment of the oliguric phase of acute renal failure.
• Reduction of intracranial pressure and treatment of cerebral edema.
• Reduction of elevated intraocular pressure when other means are ineffective.
• Promoting the urinary excretion of toxic substances[1][3][5].

Contraindications

The drug is contraindicated in patients with:

• Well-established anuria due to severe renal disease.
• Severe pulmonary congestion or frank pulmonary edema.
• Active intracranial bleeding except during craniotomy.
• Severe dehydration, including increasing oliguria and azotemia.
• Progressive heart failure or pulmonary congestion after institution of mannitol therapy[1][3].

Test Dose and Dosage

A test dose of mannitol is recommended before initiating therapy, especially for patients with marked oliguria or suspected inadequate renal function. The usual adult dosage ranges from 20 to 100 g in a 24-hour period, with the rate of administration adjusted to maintain a urine flow of at least 30 to 50 mL/hour[1][5].

Clinical Trials Overview

Clinical studies of OSMITROL Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger patients. However, other reported clinical experience has not identified significant differences in responses between the elderly and younger patients[1].

Pediatric and Geriatric Use

Safety and effectiveness in children below the age of 12 have not been established. For geriatric patients, dose selection should be cautious, considering the patient's overall health and response to the drug[1].

Market Analysis

Healthcare Context

The broader healthcare market, particularly the segments involving telemedicine and healthcare IT, is experiencing significant growth. For instance, the global telemedicine market is projected to grow from USD 97.15 billion in 2023 to USD 432.31 billion by 2032, with a CAGR of 19.0% from 2024 to 2032[2].

Relevance of OSMITROL in the Market

While OSMITROL itself is not a part of the telemedicine or healthcare IT market, its use is closely tied to the overall healthcare infrastructure. The demand for osmotic diuretics like OSMITROL is influenced by the need for effective treatments in acute care settings, such as intensive care units and surgical departments.

Competitive Landscape

The market for diuretics and other critical care medications is competitive, with various pharmaceutical companies offering similar products. However, OSMITROL's specific indications and its formulation in a plastic container, which has been tested for safety, position it as a reliable option in clinical settings[1][3].

Market Projections

Healthcare Spending Trends

The global healthcare IT market, which includes various therapeutic and diagnostic tools, is expected to grow at a CAGR of 15.8% from 2024 to 2030, reaching significant market sizes. This growth indicates an increasing investment in healthcare technologies and treatments, which could indirectly benefit the demand for critical care medications like OSMITROL[4].

Specific Projections for OSMITROL

While specific market projections for OSMITROL are not available, the growing need for effective diuretics in managing acute renal failure, cerebral edema, and other critical conditions suggests a stable or increasing demand. The advancements in healthcare infrastructure and the increasing focus on acute care will likely support the continued use of OSMITROL.

Technological and Regulatory Considerations

Container Safety

The VIAFLEX plastic container used for OSMITROL has been tested for safety according to USP biological tests for plastic containers. Although it can leach out small amounts of chemical components like di-2-ethylhexyl phthalate (DEHP), the safety of the plastic has been confirmed in animal tests[1][3].

Regulatory Compliance

OSMITROL must comply with stringent regulatory requirements, including those related to the safety of the container and the drug itself. Adherence to these regulations ensures the continued availability and trust in the product within the healthcare market.

Key Takeaways

• Clinical Use: OSMITROL is used for promoting diuresis, reducing intracranial pressure, treating cerebral edema, and lowering intraocular pressure.
• Contraindications: It is contraindicated in patients with severe renal disease, pulmonary congestion, active intracranial bleeding, and severe dehydration.
• Dosage: A test dose is recommended, and the usual adult dosage ranges from 20 to 100 g in a 24-hour period.
• Market Context: The healthcare market is growing, driven by advancements in telemedicine and healthcare IT.
• Projections: The demand for OSMITROL is expected to remain stable or increase due to its critical role in acute care settings.

Frequently Asked Questions (FAQs)

What is OSMITROL used for?

OSMITROL is used to promote diuresis, reduce intracranial pressure, treat cerebral edema, and lower elevated intraocular pressure.

What are the contraindications for OSMITROL?

OSMITROL is contraindicated in patients with well-established anuria due to severe renal disease, severe pulmonary congestion, active intracranial bleeding, and severe dehydration.

How is OSMITROL administered?

OSMITROL is administered intravenously, with a recommended test dose before initiating therapy. The usual adult dosage ranges from 20 to 100 g in a 24-hour period.

Is OSMITROL safe for pediatric and geriatric patients?

Safety and effectiveness in children below 12 years have not been established. For geriatric patients, dose selection should be cautious.

What is the market outlook for OSMITROL?

The demand for OSMITROL is expected to remain stable or increase due to its critical role in acute care settings, supported by the growing healthcare market.

Sources Cited

1. OSMITROL Injection (Mannitol Injection, USP) Label - FDA.
2. Telemedicine Market Size, Share, Growth | Global Report [2032] - Fortune Business Insights.
3. OSMITROL INJECTION - Baxter.
4. Healthcare IT Market Size, Share And Growth Report, 2030 - Grand View Research.
5. Osmitrol Injection in Aviva - RxList.