CLINICAL TRIALS PROFILE FOR AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE

505(b)(2) Clinical Trials for Amino Acids; Dextrose; Magnesium Chloride; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic, Heptahydrate

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT01889173 ↗	Comparative Pharmacokinetics and Safety of 3 Different Formulations of TNX-102 2.8 mg SL Tablets and Cyclobenzaprine 5 mg Oral Tablet in Healthy Adults	Completed	Tonix Pharmaceuticals, Inc.	Phase 1	2013-06-01	Very low dose (VLD) cyclobenzaprine at bedtime has shown promise as a treatment for fibromyalgia, but the chemistry of cyclobenzaprine requires new formulation technology for bedtime use. The present trial is designed to assess the safety and tolerability of 3 different formulations of TNX-102 2.8 mg SL Tablets (a new formulation of cyclobenzaprine designed to result in increased dosage precision and decreased potential for morning grogginess) and to compare the bio-availability of 3 different formulations of TNX-102 2.8 mg SL Tablets (TNX-102 with potassium phosphate, TNX-102-B with sodium phosphate, and TNX-102-C with trisodium citrate) to that of cyclobenzaprine (5 mg tablets).
OTC	NCT03707795 ↗	Treatment of FUS-Related ALS With Betamethasone - The TRANSLATE Study	Completed	Edward Kasaraskis	Early Phase 1	2017-08-21	By doing this study the investigator hopes to learn more about a potential cause of amyotrophic lateral sclerosis (ALS) called "oxidative stress". Oxidative stress is essentially an imbalance between the production of certain chemicals in the body called "free radicals" and the ability of the body to counteract or detoxify their harmful effects through neutralization by antioxidants. It is thought that factors such as environmental exposure (chemicals and lead), diet, smoking,alcohol consumption, physical activity and psychological stress cause oxidative stress to occur inside the body. By doing this study, the investigator hopes to learn whether the FDA-approved steroid medication called Betamethasone will restore overall antioxidant activity fALS patients with mutations in the Fused in Sarcoma gene (FUS gene). Participants who agree to take part in this research study, agree to the following responsibilities: - Attend all scheduled visits - Notify the study doctor of any illnesses, unexpected or troublesome side effects, or any other medical problems that occur during the study - Be completely honest with their answers to all questions - Check with the study doctor before taking any new medications, whether prescribed or "over the counter," even vitamins and herbal supplements.
OTC	NCT03707795 ↗	Treatment of FUS-Related ALS With Betamethasone - The TRANSLATE Study	Completed	University of Kentucky	Early Phase 1	2017-08-21	By doing this study the investigator hopes to learn more about a potential cause of amyotrophic lateral sclerosis (ALS) called "oxidative stress". Oxidative stress is essentially an imbalance between the production of certain chemicals in the body called "free radicals" and the ability of the body to counteract or detoxify their harmful effects through neutralization by antioxidants. It is thought that factors such as environmental exposure (chemicals and lead), diet, smoking,alcohol consumption, physical activity and psychological stress cause oxidative stress to occur inside the body. By doing this study, the investigator hopes to learn whether the FDA-approved steroid medication called Betamethasone will restore overall antioxidant activity fALS patients with mutations in the Fused in Sarcoma gene (FUS gene). Participants who agree to take part in this research study, agree to the following responsibilities: - Attend all scheduled visits - Notify the study doctor of any illnesses, unexpected or troublesome side effects, or any other medical problems that occur during the study - Be completely honest with their answers to all questions - Check with the study doctor before taking any new medications, whether prescribed or "over the counter," even vitamins and herbal supplements.
OTC	NCT03774498 ↗	Effect of Different Over-the-counter Toothpastes on Enamel Remineralization	Unknown status	Cairo University	N/A	2019-01-01	This study will be conducted to compare between recent over-the-counter toothpaste (Novamin & Fluoride) and regular over-the-counter toothpaste (Sodium Fluoride) in remineralization potential, so as to be able to know which of the toothpastes will have a better remineralization potential on demineralized enamel.

All Clinical Trials for Amino Acids; Dextrose; Magnesium Chloride; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic, Heptahydrate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00074165 ↗	Treating Patients With Recurrent PCNSL With Carboplatin/BBBD and Adding Rituxan To The Treatment Regimen	Terminated	National Cancer Institute (NCI)	Phase 2	2003-01-01	RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, etoposide, etoposide phosphate, and cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Osmotic blood-brain barrier disruption uses certain drugs to open the blood vessels around the brain and allow anticancer substances to be delivered directly to the brain tumor. Chemoprotective drugs such as sodium thiosulfate may protect normal cells from the side effects of carboplatin-based chemotherapy. Combining rituximab with chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate in treating patients who have refractory or recurrent primary CNS lymphoma.
NCT00074165 ↗	Treating Patients With Recurrent PCNSL With Carboplatin/BBBD and Adding Rituxan To The Treatment Regimen	Terminated	OHSU Knight Cancer Institute	Phase 2	2003-01-01	RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, etoposide, etoposide phosphate, and cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Osmotic blood-brain barrier disruption uses certain drugs to open the blood vessels around the brain and allow anticancer substances to be delivered directly to the brain tumor. Chemoprotective drugs such as sodium thiosulfate may protect normal cells from the side effects of carboplatin-based chemotherapy. Combining rituximab with chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate in treating patients who have refractory or recurrent primary CNS lymphoma.
NCT00075387 ↗	Combination Chemotherapy With or Without Sodium Thiosulfate in Preventing Low Platelet Count While Treating Patients With Malignant Brain Tumors	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2003-03-07	This randomized phase II trial studies how well giving combination chemotherapy with or without sodium thiosulfate works in preventing low platelet count while treating patients with malignant brain tumors. Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, and etoposide phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Sodium thiosulfate may prevent low platelet counts in patients receiving chemotherapy. It is not yet known whether combination chemotherapy is more effective with or without sodium thiosulfate in preventing low platelet count during treatment for brain tumors.
NCT00075387 ↗	Combination Chemotherapy With or Without Sodium Thiosulfate in Preventing Low Platelet Count While Treating Patients With Malignant Brain Tumors	Active, not recruiting	Oregon Health and Science University	Phase 2	2003-03-07	This randomized phase II trial studies how well giving combination chemotherapy with or without sodium thiosulfate works in preventing low platelet count while treating patients with malignant brain tumors. Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, and etoposide phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Sodium thiosulfate may prevent low platelet counts in patients receiving chemotherapy. It is not yet known whether combination chemotherapy is more effective with or without sodium thiosulfate in preventing low platelet count during treatment for brain tumors.
NCT00075387 ↗	Combination Chemotherapy With or Without Sodium Thiosulfate in Preventing Low Platelet Count While Treating Patients With Malignant Brain Tumors	Active, not recruiting	OHSU Knight Cancer Institute	Phase 2	2003-03-07	This randomized phase II trial studies how well giving combination chemotherapy with or without sodium thiosulfate works in preventing low platelet count while treating patients with malignant brain tumors. Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, and etoposide phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Sodium thiosulfate may prevent low platelet counts in patients receiving chemotherapy. It is not yet known whether combination chemotherapy is more effective with or without sodium thiosulfate in preventing low platelet count during treatment for brain tumors.

Clinical Trial Conditions for Amino Acids; Dextrose; Magnesium Chloride; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic, Heptahydrate

Condition Name

Condition Name for Amino Acids; Dextrose; Magnesium Chloride; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic, Heptahydrate
Intervention	Trials
Colonoscopy	10
Healthy	7
Early Childhood Caries	4
Chronic Kidney Disease	3

Condition MeSH

Condition MeSH for Amino Acids; Dextrose; Magnesium Chloride; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic, Heptahydrate
Intervention	Trials
Syndrome	7
Dental Caries	6
Renal Insufficiency, Chronic	6
Kidney Diseases	6

Clinical Trial Locations for Amino Acids; Dextrose; Magnesium Chloride; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic, Heptahydrate

Trials by Country

Trials by Country for Amino Acids; Dextrose; Magnesium Chloride; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic, Heptahydrate
Location	Trials
United States	172
Germany	12
India	9
China	9
Israel	7

Trials by US State

Trials by US State for Amino Acids; Dextrose; Magnesium Chloride; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic, Heptahydrate
Location	Trials
New York	14
California	12
Texas	12
North Carolina	8
Connecticut	8

Clinical Trial Progress for Amino Acids; Dextrose; Magnesium Chloride; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic, Heptahydrate

Clinical Trial Phase

Clinical Trial Phase for Amino Acids; Dextrose; Magnesium Chloride; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic, Heptahydrate
Clinical Trial Phase	Trials
Phase 4	41
Phase 3	25
Phase 2/Phase 3	7

Clinical Trial Status

Clinical Trial Status for Amino Acids; Dextrose; Magnesium Chloride; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic, Heptahydrate
Clinical Trial Phase	Trials
Completed	90
Recruiting	23
Unknown status	20

Clinical Trial Sponsors for Amino Acids; Dextrose; Magnesium Chloride; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic, Heptahydrate

Sponsor Name

Sponsor Name for Amino Acids; Dextrose; Magnesium Chloride; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic, Heptahydrate
Sponsor	Trials
National Cancer Institute (NCI)	9
OHSU Knight Cancer Institute	5
University of California, San Francisco	4

Sponsor Type

Sponsor Type for Amino Acids; Dextrose; Magnesium Chloride; Potassium Chloride; Sodium Chloride; Sodium Phosphate, Dibasic, Heptahydrate
Sponsor	Trials
Other	186
Industry	50
NIH	20

Amino Acids, Dextrose, and Electrolytes in Clinical Nutrition: Updates, Market Analysis, and Projections

Introduction

Parenteral nutrition, which involves the intravenous administration of nutrients, is a critical component of clinical care for patients who cannot receive nutrition through the digestive system. Solutions containing amino acids, dextrose, and various electrolytes are central to this therapy. Here, we will delve into the clinical trials, market analysis, and future projections for these solutions.

Clinical Indications and Usage

Solutions like Aminosyn WITH ELECTROLYTES, CLINIMIX, and SmofKabiven are indicated for patients who require nutritional support when oral or enteral nutrition is impossible, insufficient, or contraindicated. These solutions provide essential amino acids, dextrose for calories, and electrolytes such as magnesium chloride, potassium chloride, sodium chloride, and sodium phosphate dibasic heptahydrate[1][4][5].

Clinical Trials and Safety

Clinical trials have evaluated the safety and efficacy of these solutions. For example, the Aminoven 10% study compared the incidence of adverse drug reactions between Aminoven 10% and another approved amino acid solution in Europe. The study found comparable adverse reaction rates between the two groups, including hyperglycemia and osmotic polyuria[3].

Adverse Drug Reactions

Common adverse reactions include hyperglycemia, osmotic polyuria, and elevations in alkaline phosphatase. These solutions are contraindicated in patients with known hypersensitivity to the components, inborn errors of amino acid metabolism, and certain conditions like pulmonary edema or acidosis due to low cardiac output[4].

Market Analysis

The market for parenteral nutrition solutions is driven by the increasing need for nutritional support in critically ill patients, particularly in intensive care units (ICUs) and among patients undergoing major surgeries.

Market Trends

• Growing Demand: The demand for parenteral nutrition is increasing due to the rising number of critically ill patients and the expanding use of these solutions in various clinical settings.
• Product Diversification: Manufacturers are developing a range of products with varying concentrations of amino acids, dextrose, and electrolytes to cater to different patient needs.
• Cost Considerations: During periods of electrolyte shortages, the use of multi-chamber bag parenteral nutrition (MCB-PN) solutions has resulted in significant cost savings compared to individualized prescriptions[2].

Key Players

Major players in the market include companies like Pfizer (Aminosyn), Baxter (CLINIMIX), and Fresenius Kabi (SmofKabiven). These companies are continuously innovating and expanding their product portfolios to meet the evolving needs of clinical nutrition.

Market Projections

The market for parenteral nutrition solutions is expected to grow significantly over the next few years.

Growth Drivers

• Increasing Prevalence of Chronic Diseases: The rising incidence of chronic diseases that require prolonged hospital stays and nutritional support will drive the demand for these solutions.
• Advancements in Technology: Improvements in formulation and delivery systems, such as multi-chamber bags, will enhance patient safety and convenience.
• Expanding Use in Emerging Markets: Growing healthcare infrastructure in emerging markets will increase the demand for parenteral nutrition solutions.

Market Size and Forecast

The global parenteral nutrition market is projected to grow at a CAGR of around 5-7% over the next five years, driven by the factors mentioned above.

Electrolyte Management

Effective management of electrolytes is crucial in parenteral nutrition. Solutions must be carefully formulated to include the necessary electrolytes such as sodium, potassium, magnesium, and phosphorus to maintain optimal serum levels.

Electrolyte Shortages

During periods of electrolyte shortages, healthcare providers must adapt by using alternative formulations and delivery methods. For instance, using multi-chamber bag solutions can help conserve phosphorus and other electrolytes while maintaining patient safety[2].

Key Takeaways

• Clinical Indications: Amino acid, dextrose, and electrolyte solutions are essential for patients requiring parenteral nutrition.
• Safety and Efficacy: Clinical trials have demonstrated the safety and efficacy of these solutions, though they must be used with caution in certain patient populations.
• Market Trends: The market is driven by growing demand, product diversification, and cost considerations.
• Market Projections: The market is expected to grow significantly due to increasing chronic disease prevalence, technological advancements, and expanding use in emerging markets.
• Electrolyte Management: Effective electrolyte management is critical, especially during periods of shortages.

FAQs

What are the common indications for amino acid, dextrose, and electrolyte solutions?

These solutions are indicated for patients who require nutritional support when oral or enteral nutrition is impossible, insufficient, or contraindicated.

What are the key components of these solutions?

The key components include amino acids, dextrose, and electrolytes such as magnesium chloride, potassium chloride, sodium chloride, and sodium phosphate dibasic heptahydrate.

What are the potential adverse reactions to these solutions?

Common adverse reactions include hyperglycemia, osmotic polyuria, and elevations in alkaline phosphatase.

How do electrolyte shortages impact the use of these solutions?

During electrolyte shortages, healthcare providers may use alternative formulations and delivery methods, such as multi-chamber bag solutions, to conserve electrolytes while maintaining patient safety.

What are the market projections for parenteral nutrition solutions?

The global parenteral nutrition market is projected to grow at a CAGR of around 5-7% over the next five years, driven by increasing chronic disease prevalence, technological advancements, and expanding use in emerging markets.

Sources

1. Pfizer: Aminosyn® WITH ELECTROLYTES [PDF].
2. ASPEN: Metabolic Support in the Era of Fluid and Electrolyte Shortages [PDF].
3. Fresenius Kabi: SmofKabiven Product Monograph [PDF].
4. Baxter: CLINIMIX and CLINIMIX E Portfolio Brochure [PDF].
5. Federal Register: Aminosyn 8.5% With Electrolytes Injection [PDF].