CLINICAL TRIALS PROFILE FOR MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5

505(b)(2) Clinical Trials for Multiple Electrolytes Injection Type 1 Usp Ph 5.5

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	NCT00244777 ↗	Introduction of Hypo-osmolar ORS for Routine Use	Completed	United States Agency for International Development (USAID)	Phase 4	2002-12-01	The World Health Organization has very recently recommended the routine use of a hypo-osmolar ORS in the management of diarrhoeal diseases. This recommendation is based on the better efficacy of the hypo-osmolar ORS over the standard WHO ORS demonstrated in controlled clinical trials. The recommendation, however, also expressed the need for "careful monitoring to better assess risk, if any, of symptomatic hyponatraemia". There thus is a need for phase IV trials before the new solution is introduced into routine clinical practice to assess the risk in relatively large number of patient populations. The proposed study will be carried out at two different settings- at the urban settings of the Dhaka Hospital (60000 patients) and at the rural settings of the Matlab Hospital (15000 patients) of ICDDR,B. The hypo-osmolar rice or glucose-based ORS will be introduced as standard management of patients with diarrhoea . The hypo-osmolar ORS will contain 75 mmol /L of sodium instead of 90 mmol/L. Surveillance will be carried out to detect adverse events focusing on the occurrence of seizures or undue lethargy during hospitalization. Each episode of seizure or undue lethargy would be evaluated to determine if they are associated with abnormal levels of serum sodium or glucose, or fever. It has been estimated that about 3% (1,800) of patients initially admitted to the Short Stay Ward of the Dhaka Hospital, and 340 patients at the Matlab Hospital might require admission to the longer stay inpatient wards due to seizure or altered consciousness. Such patients would be thoroughly assessed including determination of their serum sodium and glucose, two common causes of seizures/altered consciousness, to determine if and to what extent they could be attributed to hyponatraemia.The results from this study would be used in planning and implementing the routine use of the new formulation of ORS at all Government, NGO and private health care facilities that treat diarrhoeal patients, in Bangladesh and in other countries.
New Formulation	NCT00244777 ↗	Introduction of Hypo-osmolar ORS for Routine Use	Completed	International Centre for Diarrhoeal Disease Research, Bangladesh	Phase 4	2002-12-01	The World Health Organization has very recently recommended the routine use of a hypo-osmolar ORS in the management of diarrhoeal diseases. This recommendation is based on the better efficacy of the hypo-osmolar ORS over the standard WHO ORS demonstrated in controlled clinical trials. The recommendation, however, also expressed the need for "careful monitoring to better assess risk, if any, of symptomatic hyponatraemia". There thus is a need for phase IV trials before the new solution is introduced into routine clinical practice to assess the risk in relatively large number of patient populations. The proposed study will be carried out at two different settings- at the urban settings of the Dhaka Hospital (60000 patients) and at the rural settings of the Matlab Hospital (15000 patients) of ICDDR,B. The hypo-osmolar rice or glucose-based ORS will be introduced as standard management of patients with diarrhoea . The hypo-osmolar ORS will contain 75 mmol /L of sodium instead of 90 mmol/L. Surveillance will be carried out to detect adverse events focusing on the occurrence of seizures or undue lethargy during hospitalization. Each episode of seizure or undue lethargy would be evaluated to determine if they are associated with abnormal levels of serum sodium or glucose, or fever. It has been estimated that about 3% (1,800) of patients initially admitted to the Short Stay Ward of the Dhaka Hospital, and 340 patients at the Matlab Hospital might require admission to the longer stay inpatient wards due to seizure or altered consciousness. Such patients would be thoroughly assessed including determination of their serum sodium and glucose, two common causes of seizures/altered consciousness, to determine if and to what extent they could be attributed to hyponatraemia.The results from this study would be used in planning and implementing the routine use of the new formulation of ORS at all Government, NGO and private health care facilities that treat diarrhoeal patients, in Bangladesh and in other countries.
New Formulation	NCT00490932 ↗	New Hypo-Osmolar ORS (Recommended by WHO) for Routine Use in the Diarrhea Management- Surveillance Study for Adverse Effects	Completed	Society for Applied Studies	Phase 4	2005-03-01	For more than 25 years WHO and UNICEF have recommended a single formulation of glucose-based Oral Rehydration Salts (ORS) to prevent or treat dehydration from diarrhoea irrespective of the cause or age group affected. This product has proven effective and contributed substantially to the dramatic global reduction in mortality from diarrhoeal disease during the period. Based on more than two decades of research and recommendations by an expert group, WHO and UNICEF reviewed the effectiveness of a new ORS formula with reduced concentration of glucose and salts. Because of the improved effectiveness of this new ORS solution WHO and UNICEF recommended that countries use and manufacture this new formulation in place of the old one. While recommending this new ORS the experts also recommended that further monitoring is desirable to better assess the risk, if any of symptomatic hyponatraemia (low blood level of sodium salt). This is a surveillance study to evaluate adverse effect of routinely using the new ORS in a hospital admitting over 20,000 patients with diarrhea of all ages including cholera. If the new ORS is found safe, it will provide added confidence in its global use.
New Formulation	NCT00627796 ↗	Lanreotide Autogel-120 mg as First-Line Treatment of Acromegaly	Completed	University of Genova	Phase 4	2003-01-01	Recently, a new formulation of lanreotide, lanreotide Autogel (ATG) 60 mg, 90 mg and 120 mg was developed in order to further extend the duration of the release of the active ingredient. The ATG formulation consists of a solution of lanreotide in water with no additional excipients. ATG was found to have linear pharmacokinetics for the 60 to 120 mg doses and provided a prolonged dosing interval and good tolerability (1). In some previous studies, the ATG was demonstrated as effective as the micro-particle lanreotide (2,3) and as octreotide-LAR in patients with acromegaly (4-7). Data on the efficacy of ATG in newly diagnosed patients with acromegaly are still lacking. Similarly, the prevalence and amount of tumor shrinkage after ATG treatment is unknown. This information is particularly useful in the setting of first-line therapy of acromegaly that is currently becoming a more frequent approach to the disease (8). It is demonstrated that approximately 80% of the patients treated with depot somatostatin analogues as first line have a greater than 20% tumor shrinkage during the first 12 months of treatment (9). A definition of significant tumor shrinkage was provided in 14 studies (including a total number of patients of 424) and the results showed that 36.6% (weighted mean percentage) of patients receiving first-line somatostatin analogues therapy for acromegaly had a significant reduction in tumor size (10). About 50% of the patients were found to have a greater than 50% tumor shrinkage within the first year of treatment (10); in this study we found that percent decrease in IGF-I levels was the major determinant of tumor shrinkage (10). The current open, prospective study is designed to investigate the prevalence and amount of tumor shrinkage in newly diagnosed patients with acromegaly treated first-line with ATG.
New Formulation	NCT00627796 ↗	Lanreotide Autogel-120 mg as First-Line Treatment of Acromegaly	Completed	Federico II University	Phase 4	2003-01-01	Recently, a new formulation of lanreotide, lanreotide Autogel (ATG) 60 mg, 90 mg and 120 mg was developed in order to further extend the duration of the release of the active ingredient. The ATG formulation consists of a solution of lanreotide in water with no additional excipients. ATG was found to have linear pharmacokinetics for the 60 to 120 mg doses and provided a prolonged dosing interval and good tolerability (1). In some previous studies, the ATG was demonstrated as effective as the micro-particle lanreotide (2,3) and as octreotide-LAR in patients with acromegaly (4-7). Data on the efficacy of ATG in newly diagnosed patients with acromegaly are still lacking. Similarly, the prevalence and amount of tumor shrinkage after ATG treatment is unknown. This information is particularly useful in the setting of first-line therapy of acromegaly that is currently becoming a more frequent approach to the disease (8). It is demonstrated that approximately 80% of the patients treated with depot somatostatin analogues as first line have a greater than 20% tumor shrinkage during the first 12 months of treatment (9). A definition of significant tumor shrinkage was provided in 14 studies (including a total number of patients of 424) and the results showed that 36.6% (weighted mean percentage) of patients receiving first-line somatostatin analogues therapy for acromegaly had a significant reduction in tumor size (10). About 50% of the patients were found to have a greater than 50% tumor shrinkage within the first year of treatment (10); in this study we found that percent decrease in IGF-I levels was the major determinant of tumor shrinkage (10). The current open, prospective study is designed to investigate the prevalence and amount of tumor shrinkage in newly diagnosed patients with acromegaly treated first-line with ATG.
New Formulation	NCT02909036 ↗	Study of Captisol Enabled Melphalan and Pharmacokinetics for Patients With Multiple Myeloma or Light Chain Amyloidosis That Are Receiving an Autologous Transplant.	Active, not recruiting	Spectrum Pharmaceuticals, Inc	Phase 1	2016-09-01	Captisol Enabled Melphalan, is a new formulation of the standard of care melphalan chemotherapy that in packaged in an inactive substance that is believed to help the chemotherapy be more stable (meaning that it doesn't lose its effect or need to be administered quickly after being mixed). It may also have fewer side effects such as problems with important levels of body electrolytes such as potassium, phosphorous and magnesium; and cause less kidney and heart damage] than standard formulation melphalan. The purpose of this study is to determine if the investigators can achieve a certain level of Captisol Enabled Melphalan that would be best to use in treating Multiple Myeloma and AL Amyloidosis.

All Clinical Trials for Multiple Electrolytes Injection Type 1 Usp Ph 5.5

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000574 ↗	Ibuprofen in Sepsis Study	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1990-09-01	To determine the effects of ibuprofen on mortality, development and reversal of shock, and adult respiratory distress syndrome, and on Lung Parenchymal Injury Score in adult patients with serious infection.
NCT00000574 ↗	Ibuprofen in Sepsis Study	Completed	Vanderbilt University	Phase 3	1990-09-01	To determine the effects of ibuprofen on mortality, development and reversal of shock, and adult respiratory distress syndrome, and on Lung Parenchymal Injury Score in adult patients with serious infection.
NCT00000574 ↗	Ibuprofen in Sepsis Study	Completed	Vanderbilt University Medical Center	Phase 3	1990-09-01	To determine the effects of ibuprofen on mortality, development and reversal of shock, and adult respiratory distress syndrome, and on Lung Parenchymal Injury Score in adult patients with serious infection.
NCT00004328 ↗	Phase II Study of the Pathophysiology and Treatment With Enalapril and Polystyrene Sulfonate for Pseudohypoaldosteronism, Type I	Completed	University of Texas	Phase 2	1992-12-01	OBJECTIVES: I. Establish the sodium and potassium intake that will maintain a normovolemic state in a patient with pseudohypoaldosteronism. II. Determine the effect of extracellular fluid volume and serum potassium manipulations on exercise tolerance, cardiac function, and endurance. III. Investigate pharmacologic methods of limiting excretion of sodium in urine and sweat.
NCT00004328 ↗	Phase II Study of the Pathophysiology and Treatment With Enalapril and Polystyrene Sulfonate for Pseudohypoaldosteronism, Type I	Completed	National Center for Research Resources (NCRR)	Phase 2	1992-12-01	OBJECTIVES: I. Establish the sodium and potassium intake that will maintain a normovolemic state in a patient with pseudohypoaldosteronism. II. Determine the effect of extracellular fluid volume and serum potassium manipulations on exercise tolerance, cardiac function, and endurance. III. Investigate pharmacologic methods of limiting excretion of sodium in urine and sweat.
NCT00004360 ↗	Study of Genotype and Phenotype Expression in Congenital Nephrogenic Diabetes Insipidus	Completed	Northwestern University		1995-09-01	OBJECTIVES: I. Determine the relationship between genotype variations and clinical phenotype in patients with congenital nephrogenic diabetes insipidus.

Clinical Trial Conditions for Multiple Electrolytes Injection Type 1 Usp Ph 5.5

Condition Name

Condition Name for Multiple Electrolytes Injection Type 1 Usp Ph 5.5
Intervention	Trials
Schizophrenia	11
Heart Failure	9
Hypertension	9
Healthy	8

Condition MeSH

Condition MeSH for Multiple Electrolytes Injection Type 1 Usp Ph 5.5
Intervention	Trials
Syndrome	22
Heart Failure	20
Hypertension	15
Kidney Diseases	14

Clinical Trial Locations for Multiple Electrolytes Injection Type 1 Usp Ph 5.5

Trials by Country

Trials by Country for Multiple Electrolytes Injection Type 1 Usp Ph 5.5
Location	Trials
United States	344
Canada	37
China	35
United Kingdom	34
Egypt	25

Trials by US State

Trials by US State for Multiple Electrolytes Injection Type 1 Usp Ph 5.5
Location	Trials
Texas	39
New York	32
California	27
Maryland	22
Pennsylvania	20

Clinical Trial Progress for Multiple Electrolytes Injection Type 1 Usp Ph 5.5

Clinical Trial Phase

Clinical Trial Phase for Multiple Electrolytes Injection Type 1 Usp Ph 5.5
Clinical Trial Phase	Trials
Phase 4	114
Phase 3	59
Phase 2/Phase 3	17

Clinical Trial Status

Clinical Trial Status for Multiple Electrolytes Injection Type 1 Usp Ph 5.5
Clinical Trial Phase	Trials
Completed	211
Recruiting	55
Terminated	46

Clinical Trial Sponsors for Multiple Electrolytes Injection Type 1 Usp Ph 5.5

Sponsor Name

Sponsor Name for Multiple Electrolytes Injection Type 1 Usp Ph 5.5
Sponsor	Trials
Baylor College of Medicine	8
University of North Carolina, Chapel Hill	8
University of Maryland	8

Sponsor Type

Sponsor Type for Multiple Electrolytes Injection Type 1 Usp Ph 5.5
Sponsor	Trials
Other	659
Industry	115
NIH	31

Multiple Electrolytes Injection Type 1 USP, pH 5.5: Clinical Trials, Market Analysis, and Projections

Introduction

Multiple Electrolytes Injection Type 1 USP, pH 5.5, is a sterile, nonpyrogenic isotonic solution designed for intravenous administration, providing essential electrolytes, water, and calories. Here, we will delve into the clinical trials, market analysis, and future projections for this critical medical product.

Clinical Trials and Adverse Reactions

Indications and Usage

Multiple Electrolytes Injection Type 1 USP, pH 5.5, is indicated as a source of water and electrolytes or as an alkalinizing agent. It is particularly useful in clinical settings requiring rapid electrolyte replenishment and hydration[1][3].

Adverse Reactions

Clinical trials and postmarketing reports have identified several adverse reactions associated with the use of Multiple Electrolytes Injection Type 1 USP, pH 5.5. These include hypersensitivity and infusion reactions such as tachycardia, palpitations, chest pain, dyspnea, flushing, and hyperemia. General disorders and administration site conditions like infusion site pain and burning sensations have also been reported. Metabolic and nutritional disorders, including hyperkalemia and hyponatremia, are additional concerns[1][3].

Contraindications

The injection is contraindicated in patients with a known hypersensitivity to the product. It is also not recommended for the treatment of hypomagnesemia, lactic acidosis, or severe metabolic acidosis in patients with severe liver and/or renal impairment. Excess administration can lead to metabolic alkalosis, so it should be avoided in patients with alkalosis or at risk for alkalosis[1][3].

Market Analysis

Market Size and Growth

The global multiple electrolytes injection market is projected to grow significantly, with an expected market size of USD 9.2 billion by 2032. North America is anticipated to be the most significant market segment due to the high demand for electrolyte solutions in healthcare settings[2].

Distribution Channels

The market is segmented by distribution channels into hospitals, clinics, and pharmacies. Hospitals are the primary consumers, given the frequent need for electrolyte replenishment in various clinical scenarios, including general hydration therapy, post-surgical care, and critical care interventions[2].

Product Variations

Multiple Electrolytes Injection Type 1 USP, pH 5.5, is available in different volumes, such as 500 mL and 1000 mL bags. The 500 mL bags are particularly popular due to their balance between volume and convenience, making them suitable for a wide range of patient needs and clinical circumstances[2].

Market Projections

Increasing Demand

The demand for multiple electrolytes injections is expected to rise due to the growing need for effective hydration and electrolyte replenishment in healthcare settings. This is driven by an increasing number of surgical procedures, critical care interventions, and the management of various metabolic disorders[2].

Technological Advancements

Advancements in intravenous administration technology and the development of more convenient and safe delivery systems are likely to enhance the market growth. For instance, the use of sterile equipment and dedicated lines to prevent air embolism will continue to be crucial[3].

Regulatory Compliance

Ensuring compliance with FDA regulations and USP standards will remain vital for manufacturers. The bioequivalence and therapeutic equivalence of new formulations will be closely monitored to ensure safety and efficacy[5].

Key Clinical and Market Considerations

Patient Population

Geriatric patients are at a higher risk of developing electrolyte imbalances, and thus, the use of Multiple Electrolytes Injection Type 1 USP, pH 5.5, in this population requires careful dose selection and monitoring of renal function[3].

Clinical Versatility

The solution's versatility in providing both hydration and electrolyte replenishment makes it a valuable tool in various clinical scenarios, from general hydration to post-surgical and critical care settings[1][3].

Economic Impact

The market growth will also be influenced by economic factors, including healthcare spending and reimbursement policies. The cost-effectiveness of multiple electrolytes injections compared to other hydration and electrolyte solutions will be a key consideration[2].

Key Takeaways

• Clinical Indications: Multiple Electrolytes Injection Type 1 USP, pH 5.5, is used as a source of water, electrolytes, and calories, and as an alkalinizing agent.
• Adverse Reactions: Hypersensitivity and infusion reactions, as well as metabolic and nutritional disorders, are potential adverse effects.
• Market Growth: The global market is projected to reach USD 9.2 billion by 2032, driven by increasing demand in healthcare settings.
• Distribution: Hospitals, clinics, and pharmacies are the primary distribution channels.
• Regulatory Compliance: Ensuring bioequivalence and therapeutic equivalence is crucial for new formulations.

FAQs

What are the primary indications for Multiple Electrolytes Injection Type 1 USP, pH 5.5?

The primary indications include serving as a source of water and electrolytes or as an alkalinizing agent.

What are the common adverse reactions associated with Multiple Electrolytes Injection Type 1 USP, pH 5.5?

Common adverse reactions include hypersensitivity and infusion reactions, infusion site pain, and metabolic disorders such as hyperkalemia and hyponatremia.

What is the expected market size of the global multiple electrolytes injection market by 2032?

The global market is expected to reach USD 9.2 billion by 2032.

In what volumes is Multiple Electrolytes Injection Type 1 USP, pH 5.5 typically available?

It is available in 500 mL and 1000 mL bags.

Why is the 500 mL bag format popular in clinical settings?

The 500 mL bag format is popular due to its balance between volume and convenience, making it suitable for various clinical circumstances.

Sources

1. DailyMed: Multiple Electrolytes Injection, Type 1, USP, pH 5.5.
2. Straits Research: Multiple Electrolytes Injection Market Size, Top Share, Demand.
3. FDA: PLASMA-LYTE 148 Injection (Multiple Electrolytes Injection, Type 1, USP).
4. USP-NF/PF: Multiple Electrolytes Injection Type 1.
5. FDA: II US FOOD & DRUG - accessdata.fda.gov.