CLINICAL TRIALS PROFILE FOR MANNITOL 10% IN PLASTIC CONTAINER

All Clinical Trials for MANNITOL 10% IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003062 ↗	Temozolomide in Patients With Progressive or Recurrent Non-small Cell Lung Cancer	Completed	European Organisation for Research and Treatment of Cancer - EORTC	Phase 2	1997-07-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effect of temozolomide in patients with progressive or recurrent stage IV non-small cell lung cancer, with or without brain metastases, who have not been treated for metastatic disease with chemotherapy.
NCT00004767 ↗	Phase II Study of Sodium Phenylbutyrate, Sodium Benzoate, Sodium Phenylacetate, and Dietary Intervention for Urea Cycle Disorders	Completed	Johns Hopkins University	Phase 2	1985-01-01	OBJECTIVES: I. Assess the safety and efficacy of sodium phenylbutyrate, sodium benzoate, sodium phenylacetate, and dietary intervention in patients with urea cycle disorders.
NCT00004767 ↗	Phase II Study of Sodium Phenylbutyrate, Sodium Benzoate, Sodium Phenylacetate, and Dietary Intervention for Urea Cycle Disorders	Completed	National Center for Research Resources (NCRR)	Phase 2	1985-01-01	OBJECTIVES: I. Assess the safety and efficacy of sodium phenylbutyrate, sodium benzoate, sodium phenylacetate, and dietary intervention in patients with urea cycle disorders.
NCT00111956 ↗	Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome	Completed	Massachusetts General Hospital	Phase 2/Phase 3	2004-04-01	Metabolic syndrome is associated with increased inflammatory cytokines and reduced adiponectin, that may be mediated in part by TNF production from abdominal fat. We reasoned that an anti-TNF agent would reduce C-reactive protein (CRP) and increase adiponectin, improving the inflammatory milieu associated with metabolic syndrome.
NCT00111956 ↗	Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2/Phase 3	2004-04-01	Metabolic syndrome is associated with increased inflammatory cytokines and reduced adiponectin, that may be mediated in part by TNF production from abdominal fat. We reasoned that an anti-TNF agent would reduce C-reactive protein (CRP) and increase adiponectin, improving the inflammatory milieu associated with metabolic syndrome.
NCT00113854 ↗	Mannitol as Adjunct Therapy for Childhood Cerebral Malaria	Unknown status	Makerere University	Phase 3	2004-10-01	Cerebral malaria is a life-threatening complication of Plasmodium falciparum infection in African children and nonimmune travellers despite availability of quinine, the current drug of choice. Several reports have suggested that raised intracranial pressure (ICP) is a major cause of death among children with cerebral malaria. Mannitol, an osmotic diuretic, effectively lowers ICP and is used to treat post traumatic raised ICP. There have been some case reports of reduction in mortality and morbidity in African children with cerebral malaria following administration of mannitol, but as these were not randomized controlled trials it is difficult to evaluate their significance. This study seeks to establish whether a single dose of intravenous mannitol given to children with cerebral malaria will significantly reduce the coma recovery time.
NCT00117182 ↗	Aridol Challenge as a Tool to Predict Treatment Response to Inhaled Corticosteroids in COPD	Completed	Pharmaxis	Phase 2	2005-07-01	The purpose of this study is to determine whether the Aridol (mannitol) challenge test can predict response to treatment with inhaled corticosteroids in COPD subjects. Subjects will undergo an Aridol test and then 3 months of treatment with inhaled corticosteroids. The effect on lung function and quality of life will then be measured and correlated with the Aridol test result.

Clinical Trial Conditions for MANNITOL 10% IN PLASTIC CONTAINER

Condition Name

Condition Name for MANNITOL 10% IN PLASTIC CONTAINER
Intervention	Trials
Asthma	20
Cystic Fibrosis	10
Healthy	7
Glioblastoma Multiforme	6

Condition MeSH

Condition MeSH for MANNITOL 10% IN PLASTIC CONTAINER
Intervention	Trials
Asthma	23
Intracranial Hypertension	12
Brain Neoplasms	10
Fibrosis	10

Clinical Trial Locations for MANNITOL 10% IN PLASTIC CONTAINER

Trials by Country

Trials by Country for MANNITOL 10% IN PLASTIC CONTAINER
Location	Trials
United States	137
Canada	38
United Kingdom	35
Australia	34
Italy	20

Trials by US State

Trials by US State for MANNITOL 10% IN PLASTIC CONTAINER
Location	Trials
New York	19
Massachusetts	12
Minnesota	9
Oregon	8
Ohio	7

Clinical Trial Progress for MANNITOL 10% IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for MANNITOL 10% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Phase 4	37
Phase 3	34
Phase 2/Phase 3	10

Clinical Trial Status

Clinical Trial Status for MANNITOL 10% IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	132
Unknown status	27
Not yet recruiting	18

Clinical Trial Sponsors for MANNITOL 10% IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for MANNITOL 10% IN PLASTIC CONTAINER
Sponsor	Trials
Pharmaxis	19
Northwell Health	7
National Cancer Institute (NCI)	6

Sponsor Type

Sponsor Type for MANNITOL 10% IN PLASTIC CONTAINER
Sponsor	Trials
Other	366
Industry	64
NIH	17

MANNITOL 10% IN PLASTIC CONTAINER Market Analysis and Financial Projection

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

Introduction to Mannitol

Mannitol, a sugar alcohol, is widely used in various medical and industrial applications due to its unique properties. It is an osmotic diuretic, metabolically inert in humans, and occurs naturally in fruits and vegetables. This article will delve into the current clinical trials, market analysis, and future projections for mannitol, particularly focusing on the 10% solution in plastic containers.

Clinical Trials and Efficacy

Current Trials and Applications

A recent clinical trial in China has introduced a novel combination of intravenous paracetamol and mannitol for managing chronic post-thoracotomy pain (CPTP) in patients with lung cancer. This trial aims to evaluate the efficacy and safety of this combination compared to normal saline. The study design is a single-center prospective randomized double-blind controlled trial, ensuring objectivity and reducing subjective bias[1].

Mannitol is also being explored for its efficacy in bowel preparation for colonoscopy. The SATISFACTION study compared single-dose oral mannitol with standard split-dose PEG-ASC2 L (MoviPrep®) and found that mannitol was not inferior in terms of bowel cleansing efficacy and had a better acceptability profile for patients[4].

Therapeutic Uses

Mannitol is used in various therapeutic applications:

• Osmotic Diuretic: It elevates blood plasma osmolality, reducing cerebral edema and intracranial pressure, making it crucial in treating conditions like acute kidney damage and brain injuries[2][3].
• Anti-Glaucoma: Mannitol is used to reduce intraocular pressure.
• Bowel Preparation: As mentioned, mannitol is effective in bowel cleansing for colonoscopy[4].
• Pharmaceutical Excipient: Mannitol is used in tablet formulations due to its stability and non-reactive nature[5].

Market Analysis

Market Size and Growth

The mannitol market has been growing steadily due to its diverse applications. In 2019, the market size was estimated to be $375 million, with a projected CAGR of 4.35% from 2020 to 2025[2].

By 2024, the global mannitol market is expected to reach $418.3 million, driven by increasing demand for confectionery and bakery products, as well as its use in pharmaceuticals[5].

Segment Analysis

By Form

• The powdered form of mannitol accounted for the largest market share in 2019, primarily due to its benefits in the production of confectionary, baked goods, and chocolates[2].

By Application

• Pharmaceuticals are projected to be the fastest-growing segment, with a CAGR of 4% from 2020 to 2025. This growth is attributed to the increasing use of mannitol as an excipient in medicine formulations[2].
• The food industry also drives demand, particularly for sugar-free products and in applications like chewing gums and chocolate coatings[5].

By Geography

• North America dominated the mannitol market in 2019, driven by the rising geriatric population and increasing health concerns. However, the Asia-Pacific region is also a significant market due to changing lifestyles and the prevalence of diseases related to sugar consumption[2][5].

Market Projections

Future Growth

The mannitol injection market is projected to grow from $267.1 million in 2024 to $367.2 million by 2031, at a CAGR of 4.1%. This growth is driven by the increasing prevalence of chronic disorders such as diabetes, hypertension, and cardiovascular diseases, as well as the rising demand for effective treatments in critical care settings[3].

Emerging Trends

• Advances in Healthcare Infrastructure: Improved access to medical treatment in developing countries is increasing the demand for mannitol injections.
• Sterile Mannitol Injections: The emphasis on safety and efficacy is propelling the demand for sterile mannitol injections, which are essential in high-risk settings like hospitals[3].
• Diverse Medicinal Applications: Mannitol’s efficacy in treating acute renal damage, cerebral edema, and glaucoma will continue to boost the market for sterile mannitol injections[3].

Key Takeaways

• Clinical Efficacy: Mannitol is being explored in clinical trials for its efficacy in managing CPTP and as a bowel preparation agent.
• Market Growth: The mannitol market is growing due to its applications in pharmaceuticals, food, and medical treatments.
• Geographical Dominance: North America and the Asia-Pacific region are significant markets driven by demographic and lifestyle changes.
• Future Projections: The market is expected to grow, driven by the increasing prevalence of chronic diseases and the need for effective treatments in critical care settings.

FAQs

What are the primary therapeutic uses of mannitol?

Mannitol is used as an osmotic diuretic, in bowel preparation for colonoscopy, as an anti-glaucoma agent, and as a pharmaceutical excipient.

How is the mannitol market expected to grow in the future?

The mannitol market is projected to grow at a CAGR of 4.1% from 2024 to 2031, driven by increasing demand for effective treatments in critical care settings and the rising prevalence of chronic diseases.

What are the key drivers of the mannitol market?

Key drivers include the increasing demand for confectionery and bakery products, the use of mannitol in pharmaceutical formulations, and the growing need for effective treatments in critical care settings.

Which region dominates the mannitol market?

North America currently dominates the mannitol market, but the Asia-Pacific region is also a significant and growing market.

What is the significance of sterile mannitol injections?

Sterile mannitol injections are crucial in high-risk settings like hospitals to ensure patient safety and minimize complications and infections.

Sources

1. Efficacy of intravenous paracetamol and mannitol in managing chronic post-thoracotomy pain in patients with lung cancer. MedRxiv, 2024.
2. Mannitol Market 2020 - 2025. IndustryARC.
3. In-Depth Industry Outlook: Mannitol Injection Market Size & Forecast. Verified Market Research.
4. Mannitol for bowel preparation: Efficacy and safety results from the SATISFACTION randomised clinical trial. PubMed, 2024.
5. Mannitol Market Projected to be Worth $418.3 Million by 2024. Grand View Research, Inc., PR Newswire.