CLINICAL TRIALS PROFILE FOR OSMITROL 10% IN WATER IN PLASTIC CONTAINER

All Clinical Trials for Osmitrol 10% 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.

Clinical Trial Conditions for Osmitrol 10% In Water In Plastic Container

Condition Name

Condition Name for Osmitrol 10% In Water In Plastic Container
Intervention	Trials
Recurrent Adult Brain Neoplasm	2
Recurrent Childhood Central Nervous System Embryonal Neoplasm	1
Adult Pineoblastoma	1
Embryonal Tumor With Multilayered Rosettes, C19MC-Altered	1

Condition MeSH

Condition MeSH for Osmitrol 10% In Water In Plastic Container
Intervention	Trials
Brain Neoplasms	2
Neuroectodermal Tumors, Primitive	1
Inflammation	1
Neuroectodermal Tumors	1

Clinical Trial Locations for Osmitrol 10% In Water In Plastic Container

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for Osmitrol 10% In Water In Plastic Container

Clinical Trial Phase

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Withdrawn	1

Clinical Trial Sponsors for Osmitrol 10% In Water In Plastic Container

Sponsor Name

Sponsor Name for Osmitrol 10% 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 10% In Water In Plastic Container
Sponsor	Trials
Other	9
NIH	4
Industry	3

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

Introduction

OSMITROL, a sterile, nonpyrogenic solution of mannitol USP, is widely used as an osmotic diuretic for various clinical indications. This article delves into the current state of clinical trials, market analysis, and future projections for OSMITROL 10% in water in plastic containers.

Clinical Indications and Uses

OSMITROL is indicated for several critical clinical conditions, including the promotion of diuresis in acute renal failure, reduction of intracranial pressure and cerebral edema, reduction of elevated intraocular pressure, and promoting the urinary excretion of toxic substances[1][2][3].

Clinical Trials Update

Ongoing and Completed Trials

Several clinical trials have been conducted or are ongoing to evaluate the efficacy and safety of mannitol in various settings. For instance, a prospective randomized double-blind placebo-controlled trial at Memorial Sloan-Kettering Cancer Center investigated the use of mannitol to prevent acute tubular necrosis (ATN) in patients undergoing partial nephrectomy. The study found a significant decrease in the incidence of ATN in the early postoperative period in the mannitol group[4].

Key Findings

• Renal Protection: Mannitol has shown promise in reducing the incidence of ATN in surgical patients, highlighting its potential in renal protection.
• Intraocular Pressure: Clinical trials have consistently demonstrated the effectiveness of mannitol in reducing intraocular pressure, making it a valuable tool in ophthalmic surgery[5].

Market Analysis

Current Market Status

OSMITROL is a well-established product in the pharmaceutical market, particularly in the segment of osmotic diuretics. It is manufactured by Baxter International Inc. and distributed globally. The market demand for OSMITROL is driven by its versatility in treating various acute conditions.

Market Trends

• Increasing Demand in Critical Care: The growing need for effective diuretics in critical care settings, such as intensive care units (ICUs) and emergency departments, is driving the demand for OSMITROL.
• Advancements in Surgical Procedures: The use of mannitol in surgical procedures, especially in neurosurgery and ophthalmology, continues to grow, contributing to the market expansion.

Competitive Landscape

The market for osmotic diuretics is relatively niche but competitive. OSMITROL competes with other mannitol-based products and other types of diuretics. However, its established brand and wide range of indications give it a strong market position.

Market Projections

Future Growth

The market for OSMITROL is expected to grow steadily over the next few years, driven by:

• Increasing Incidence of Acute Conditions: The rising incidence of acute renal failure, cerebral edema, and other conditions requiring osmotic diuretics will continue to drive demand.
• Advancements in Healthcare Infrastructure: Improvements in healthcare infrastructure, particularly in developing countries, will increase access to OSMITROL and other critical care medications.

Potential Challenges

• Regulatory Changes: Changes in regulatory requirements or safety standards could impact the production and distribution of OSMITROL.
• Generic Competition: The potential entry of generic mannitol products could challenge the market share of OSMITROL.

Safety and Contraindications

Safety Profile

OSMITROL is generally safe when used as directed, but it can cause several adverse effects, including hypersensitivity reactions, fluid and electrolyte imbalances, and hyperosmolarity. The safety of the plastic container used for OSMITROL has been confirmed through various tests, including USP biological tests and tissue culture toxicity studies[1][2][3].

Contraindications

OSMITROL is contraindicated in patients with well-established anuria due to severe renal disease, severe pulmonary congestion or pulmonary edema, active intracranial bleeding (except during craniotomy), severe dehydration, and pre-existing plasma hyperosmolarity[1][2][3].

Dosage and Administration

Recommended Dosage

The dosage of OSMITROL varies based on the clinical indication. For example, for reducing intraocular pressure, a dose of 1.5 to 2 grams/kg as a 20% solution is recommended, administered intravenously over at least 30 minutes[2][5].

Administration Guidelines

• Test Dose: A test dose should be administered before the full dose to assess patient response.
• Rate of Administration: The rate should be adjusted to maintain a urine flow of at least 30 to 50 mL/hour[2][3].

Key Takeaways

• Clinical Indications: OSMITROL is used for promoting diuresis, reducing intracranial and intraocular pressure, and promoting the excretion of toxic substances.
• Clinical Trials: Ongoing and completed trials highlight the efficacy of mannitol in various clinical settings.
• Market Analysis: The market for OSMITROL is driven by its versatility and the growing demand in critical care and surgical procedures.
• Future Projections: Steady growth is expected due to increasing incidence of acute conditions and advancements in healthcare infrastructure.
• Safety Profile: OSMITROL is generally safe but requires careful administration to avoid adverse effects.

FAQs

What are the primary indications for OSMITROL?

OSMITROL is indicated for the promotion of diuresis in acute renal failure, reduction of intracranial pressure and cerebral edema, reduction of elevated intraocular pressure, and promoting the urinary excretion of toxic substances.

What are the contraindications for OSMITROL?

OSMITROL is contraindicated in patients with well-established anuria due to severe renal disease, severe pulmonary congestion or pulmonary edema, active intracranial bleeding (except during craniotomy), severe dehydration, and pre-existing plasma hyperosmolarity.

How is OSMITROL administered?

OSMITROL is administered intravenously, with the dosage and rate adjusted based on the clinical indication and patient response. A test dose is recommended before the full dose.

What are the potential side effects of OSMITROL?

Potential side effects include hypersensitivity reactions, fluid and electrolyte imbalances, hyperosmolarity, and other complications related to osmotic diuresis.

Is OSMITROL safe for use in patients with renal failure?

OSMITROL is contraindicated in patients with well-established anuria due to severe renal disease. Its use in patients with renal failure must be carefully considered and monitored.

Sources

1. Baxter Corporation. Prescribing Information Osmitrol Injection 10% Mannitol Injection USP 10% Osmitrol Injection 20% Mannitol Injection USP 20% Solution for Infusion.
2. Medsafe. NEW ZEALAND DATA SHEET Osmitrol.
3. FDA. OSMITROL Injection (Mannitol Injection, USP) in VIAFLEX Plastic Container.
4. ClinicalTrials.gov. Memorial Sloan-Kettering Cancer Center - Study to Evaluate the Use of Mannitol for Renal Protection.
5. DailyMed. Label: OSMITROL- mannitol injection, solution.

Last updated: 2025-01-07