CLINICAL TRIALS PROFILE FOR MANNITOL 20%

All Clinical Trials for Mannitol 20%

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.

Clinical Trial Conditions for Mannitol 20%

Condition Name

Condition Name for Mannitol 20%
Intervention	Trials
Asthma	20
Cystic Fibrosis	10
Healthy	7
Traumatic Brain Injury	6

Condition MeSH

Condition MeSH for Mannitol 20%
Intervention	Trials
Asthma	23
Intracranial Hypertension	12
Cystic Fibrosis	10
Brain Neoplasms	10

Clinical Trial Locations for Mannitol 20%

Trials by Country

Trials by Country for Mannitol 20%
Location	Trials
United States	137
Canada	38
United Kingdom	35
Australia	34
Italy	20

Trials by US State

Trials by US State for Mannitol 20%
Location	Trials
New York	19
Massachusetts	12
Minnesota	9
Oregon	8
Ohio	7

Clinical Trial Progress for Mannitol 20%

Clinical Trial Phase

Clinical Trial Phase for Mannitol 20%
Clinical Trial Phase	Trials
Phase 4	37
Phase 3	34
Phase 2/Phase 3	10

Clinical Trial Status

Clinical Trial Status for Mannitol 20%
Clinical Trial Phase	Trials
Completed	132
Unknown status	27
Not yet recruiting	18

Clinical Trial Sponsors for Mannitol 20%

Sponsor Name

Sponsor Name for Mannitol 20%
Sponsor	Trials
Pharmaxis	19
Northwell Health	7
Ain Shams University	6

Sponsor Type

Sponsor Type for Mannitol 20%
Sponsor	Trials
Other	366
Industry	64
NIH	17

Mannitol 20%: Clinical Trials, Market Analysis, and Projections

Introduction to Mannitol 20%

Mannitol, a sugar alcohol, is widely used in medical and pharmaceutical applications. At a concentration of 20%, it is particularly notable for its use in managing elevated intracranial pressure and other medical conditions. Here, we will delve into recent clinical trials, market analysis, and future projections for mannitol 20%.

Clinical Trials and Safety

Safety and Tolerability in Parkinson's Disease

A recent clinical trial focused on the safety and tolerability of oral mannitol in patients with Parkinson's disease. The study, conducted at the Hadassah Medical Center in Jerusalem, involved 27 participants randomized to receive either oral mannitol or a placebo. The dose was gradually increased to a maximum of 18 grams per day. The results indicated that long-term use of 18 grams per day of oral mannitol is safe, although only two-thirds of the patients tolerated this maximal dose. Adherence to the treatment was high, with minimal severe adverse events unrelated to the mannitol treatment[1].

Comparison with Hypertonic Saline in Pediatric CNS Infections

In a randomized clinical trial, 20% mannitol was compared to 3% hypertonic saline in pediatric patients with acute CNS infections and elevated intracranial pressure. The study found that 3% hypertonic saline was more effective in reducing intracranial pressure and improving cerebral perfusion pressure compared to 20% mannitol. The hypertonic saline group also showed better clinical outcomes, including lower mortality and shorter durations of mechanical ventilation and PICU stay[3].

Effect on Optic Nerve Sheath Diameter

A prospective observational study investigated the effect of intravenous administration of 20% mannitol on the optic nerve sheath diameter (ONSD) in patients with raised intracranial pressure. This study aimed to determine the changes in ONSD after mannitol administration, which could help in noninvasive monitoring and tailoring treatment modalities. The results highlighted the potential of using ONSD as a noninvasive marker for monitoring the efficacy of mannitol osmotherapy[4].

Market Analysis

Global Market Size and Growth

The global mannitol market has been experiencing significant growth. In 2022, the market size was valued at approximately USD 418.65 million and is projected to reach USD 890.31 million by 2033, growing at a CAGR of 7.1% during the forecast period from 2023 to 2033[5].

Regional Market Dynamics

Asia Pacific dominates the global mannitol market, with emerging markets like China and India contributing substantially. The region's growth is driven by increasing consumer health consciousness and the rising prevalence of diseases such as diabetes and cardiovascular conditions. Europe is expected to be the fastest-growing region, driven by expanding R&D activities and rising demand from various end-user industries[2][5].

Application Segments

Mannitol is used in various applications, including as an excipient in pharmaceutical formulations, treatment of brain, kidney, and heart problems, and as a bulking agent in tableting. The food additive segment accounts for more than 35% of the total market, driven by changing consumer preferences towards healthier diets and lifestyle management[2].

Market Projections

Future Growth Drivers

The mannitol market is expected to benefit from several factors, including a growing population, evolving lifestyles, and an increase in certain diseases. The demand for food-grade mannitol is rising due to consumer preferences for healthier options, which is anticipated to support market growth over the next decade[2][5].

Challenges and Opportunities

While mannitol has several benefits, its use is not without challenges. The side effects associated with mannitol, particularly in high doses, can be significant. However, ongoing research and clinical trials are aimed at optimizing dosing strategies and improving safety profiles. The increasing demand from pharmaceutical and food industries presents significant opportunities for market growth[1][3].

Key Takeaways

• Clinical Safety: Mannitol 20% has been shown to be safe in various clinical settings, although tolerability can vary.
• Efficacy Comparison: In certain conditions, such as pediatric CNS infections, hypertonic saline may be more effective than mannitol in reducing intracranial pressure.
• Market Growth: The global mannitol market is projected to grow significantly, driven by increasing demand from pharmaceutical, food, and other industries.
• Regional Dynamics: Asia Pacific and Europe are key regions driving the market growth due to consumer health consciousness and R&D activities.
• Application Diversity: Mannitol is used in multiple applications, including pharmaceutical formulations, medical treatments, and food additives.

FAQs

What is the primary use of mannitol 20% in medical settings?

Mannitol 20% is primarily used to manage elevated intracranial pressure and in osmotherapy for conditions such as traumatic brain injury, acute stroke, and intracranial hemorrhage.

How does mannitol 20% compare to hypertonic saline in reducing intracranial pressure?

In pediatric acute CNS infections, 3% hypertonic saline has been shown to be more effective than 20% mannitol in reducing intracranial pressure and improving cerebral perfusion pressure[3].

What are the key drivers of the global mannitol market growth?

The global mannitol market growth is driven by a growing population, evolving lifestyles, increasing demand for healthier food options, and expanding R&D activities in pharmaceutical and other industries[2][5].

What are the common side effects associated with mannitol 20%?

While generally safe, mannitol 20% can have significant side effects, particularly at high doses. These include gastrointestinal issues, electrolyte imbalances, and in some cases, severe adverse events unrelated to the treatment[1].

How is mannitol used in the food industry?

Mannitol is used as a food additive, accounting for more than 35% of the total market. It is employed in diet and lifestyle management products due to changing consumer preferences towards healthier options[2].

Sources

1. Frontiers in Neurology: "Safety and Tolerability, Dose-Escalating, Double-Blind Trial of Oral Mannitol in Patients with Parkinson's Disease"[1].
2. SkyQuest Market Research: "Mannitol Market Growth, Size & Share Analysis | 2032"[2].
3. PubMed: "Randomized Clinical Trial of 20% Mannitol Versus 3% Hypertonic Saline in Pediatric Acute CNS Infections"[3].
4. ClinicalTrials.gov: "Effect of Intravenous Administration of 20% Mannitol on the Optic Nerve Sheath Diameter (ONSD) in Patients with Raised Intracranial Pressure"[4].
5. Future Market Insights: "Mannitol Market Size, Share, Outlook & Forecast by 2033"[5].