CLINICAL TRIALS PROFILE FOR BALANCED SALT

505(b)(2) Clinical Trials for Balanced Salt

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	NCT00741741 ↗	TMC278-TiDP15-C150: Trial to Examine Safety, Tolerability and Plasma Pharmacokinetics of Multiple Doses of TMC278LA.	Terminated	Tibotec Pharmaceuticals, Ireland	Phase 1	2008-07-01	The purpose of this study is: to determine the safety, (local) tolerability and plasma exposure over time of single intramuscular (IM) doses of 600 and 1200 mg of a new formulation (F006) of TMC278LA, to determine the safety, (local) tolerability and long-term plasma exposure over time of 2 dose regimens of 4 monthly IM doses of a new formulation (F006) of TMC278LA., To determine the safety, (local) tolerability and long-term plasma exposure over time of 1 dose regimen of 4 monthly subcutaneous (SC) doses of a new formulation (F006) of TMC278LA.
New Formulation	NCT01648257 ↗	Relative Bioavailability Study of GSK1265744 Formulations	Completed	ViiV Healthcare	Phase 1	2012-08-01	This is a single-center, randomized, open-label, balanced, 3 way crossover study (3 periods) in healthy adult subjects. During each period, subjects will receive a single dose of GSK1265744 oral formulation in the fasted state and serial PK sampling for up to 168 hours (8 days) and safety assessments will be performed. Each period will be separated by a washout period of at least 14 days and a follow-up visit will occur 10 to 14 days after the last dose of study drug.
OTC	NCT02137213 ↗	Feasibility Study of Oral Naloxone for Treatment of Methadone-induced Constipation	Completed	Academic Health Science Centres	Phase 2	2014-08-01	At least 30% of patients receiving methadone maintenance therapy (MMT) are suffering from constipation that often affects effectiveness of MMT and increases its impact on health care system. Existing treatments include several over-the-counter medications which do not target the pathobiological basis of opioid-induced constipation and have limited effectiveness. At the same time well-known medication, naloxone, was already shown to help with constipation in patients receiving methadone for chronic pain, but was never tried in patients receiving methadone for opioid dependence. This study is aimed to try naloxone for treatment of opioid-induced constipation in MMT settings. The investigators will enroll 20 patients receiving MMT and suffering from opioid-induced constipation. The study has a crossover design - all patients will receive one week of their regular methadone doses and one week of their regular methadone doses with naloxone added. Normal saline will be added to methadone-only formulations as placebo. Order of the weeks will be chosen randomly. Both subjects and investigators will be blinded to the study condition (i.e. whether naloxone or normal saline is added to methadone preparation on a given week). Primary hypothesis: Patients receiving combination of oral methadone/naloxone in ratio 50:1 will have less severe symptoms of constipation compared to those receiving methadone only. Secondary hypothesis: Addition of oral naloxone to methadone in a ratio 50:1 will not cause clinically significant opioid withdrawal symptoms.

All Clinical Trials for Balanced Salt

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.

Clinical Trial Conditions for Balanced Salt

Condition Name

Condition Name for Balanced Salt
Intervention	Trials
Healthy	172
Fasting	16
Bioequivalence	15

Condition MeSH

Condition MeSH for Balanced Salt
Intervention	Trials
Malnutrition	69
Alcoholism	17
Pain, Postoperative	16

Clinical Trial Locations for Balanced Salt

Trials by Country

Trials by Country for Balanced Salt
Location	Trials
United States	614
India	179
Italy	78
Canada	62
Germany	62

Trials by US State

Trials by US State for Balanced Salt
Location	Trials
New York	47
California	43
Texas	39
Florida	31
Ohio	28

Clinical Trial Progress for Balanced Salt

Clinical Trial Phase

Clinical Trial Phase for Balanced Salt
Clinical Trial Phase	Trials
Phase 4	173
Phase 3	116
Phase 2/Phase 3	30

Clinical Trial Status

Clinical Trial Status for Balanced Salt
Clinical Trial Phase	Trials
Completed	647
Recruiting	106
Not yet recruiting	85

Clinical Trial Sponsors for Balanced Salt

Sponsor Name

Sponsor Name for Balanced Salt
Sponsor	Trials
Dr. Reddy's Laboratories Limited	88
Ranbaxy Laboratories Limited	58
GlaxoSmithKline	31

Sponsor Type

Sponsor Type for Balanced Salt
Sponsor	Trials
Other	921
Industry	551
NIH	61

Balanced Salt Solutions: Clinical Trials, Market Analysis, and Projections

Introduction to Balanced Salt Solutions

Balanced salt solutions are crucial in medical and research settings, particularly in intensive care units (ICUs) and in various biomedical applications such as cell culture and drug discovery. These solutions are designed to mimic the natural environment of the human body, providing essential nutrients and maintaining a stable pH level, which is vital for cell growth and maintenance.

Clinical Trials: Comparing Balanced Salt Solutions to Saline

Several clinical trials have been conducted to compare the efficacy and safety of balanced salt solutions versus saline solutions in critically ill patients.

The CHLORIDE Trial

The Chloride High Level of Resuscitation Infusion Delivered Evaluation (CHLORIDE) trial was one of the first studies to demonstrate that balanced salt solutions might reduce the incidence of acute kidney injury (AKI) compared to saline solutions. This prospective, open-label study involved 760 patients in an ICU setting and showed significantly less AKI with the use of balanced solutions like Hartmann’s solution and Plasma-Lyte 148[1].

The SPLIT Trial

The 0.9% Saline vs. Plasma-Lyte 148 for Intensive Care Fluid Therapy (SPLIT) trial, published in 2015, further supported the findings of the CHLORIDE trial. This study, conducted in an ICU setting, also found that balanced crystalloids reduced the incidence of AKI compared to saline[1].

The SMART Trial

The Isotonic Solutions and Major Adverse Renal Events Trial (SMART) was a large, pragmatic study that randomized over 15,000 adults in an ICU setting to receive either balanced crystalloids or saline. The study found a statistically significant reduction in major adverse kidney events (MAKE-30) in the balanced crystalloids group[1].

The BaSICS Trial

The Balanced Solution Versus Saline in Intensive Care Study (BaSICS) trial, a multi-center, double-blind randomized controlled trial (RCT), randomized approximately 11,000 patients to balanced crystalloids or saline groups. Although this study found no difference in 90-day mortality between the two groups, it did highlight that balanced solutions resulted in significantly lower chloride levels, which could be beneficial in reducing AKI and other complications[1][4].

Meta-Analysis and Systematic Reviews

A meta-analysis by Hammond et al. in 2022 combined data from the BaSICS and PLUS trials along with 11 other RCTs. This analysis showed a reduction in the relative risk of both mortality and AKI in patients receiving balanced solutions, indicating a potential benefit of using balanced salt solutions over saline in clinical settings[1].

Market Analysis and Projections

Market Size and Growth

The balanced salt solutions market is expected to grow steadily, driven by several key factors. As of 2022, the market size was valued at US$ 2.23 billion and is projected to reach US$ 2.98 billion by 2029, growing at a Compound Annual Growth Rate (CAGR) of 4.2% during the forecast period[2][5].

Market Drivers

• Growing Prevalence of Chronic Diseases: The increasing prevalence of chronic diseases is driving the demand for advanced medical treatments, which in turn boosts the need for balanced salt solutions in research and clinical applications[5].
• Advancements in Biotechnology: Advances in biotechnology research, particularly in cell culture and drug discovery, are significant drivers of the market. Balanced salt solutions provide the optimal environment necessary for these processes[5].
• Expanding Pharmaceutical Industry: The growth of the pharmaceutical and biotechnology industries, especially in regions like North America and the Asia Pacific, is driving the demand for balanced salt solutions[2][5].

Market Segments

• By Product: The market includes various types of balanced salt solutions such as Hanks' Balanced Salt Solution, Gey's Balanced Salt Solution, Earle's Balanced Salt Solution, and Dulbecco's Phosphate Buffered Saline[2].
• By End User: Key end-users include research institutes, pharmaceutical and biotechnology companies, and other healthcare facilities[2].
• By Application: Balanced salt solutions are used in biopharmaceuticals, therapeutics, stem cell technology, drug screening and development, genetic engineering, cancer research, and other biomedical applications[2].

Regional Analysis

The market is geographically segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa. North America currently dominates the market due to the presence of well-established pharmaceutical and biotechnology industries. However, the Asia Pacific region is expected to witness significant growth due to increasing investments in research and development and a growing focus on healthcare infrastructure[5].

Market Restraints

• Stringent Regulatory Requirements: The stringent regulatory requirements for drug development and commercialization can act as a restraint for the market[5].
• High Production Costs: The high costs associated with the production and maintenance of cell cultures using balanced salt solutions can be a significant barrier[5].
• Limited Awareness: Limited awareness and adoption of balanced salt solutions in certain regions can also hinder market growth[5].

Market Opportunities

• Emerging Economies: Emerging economies present untapped market potential for balanced salt solutions, driven by increasing investments in healthcare and research infrastructure[5].
• Stem Cell Research and Regenerative Medicine: The increasing focus on stem cell research and regenerative medicine offers new opportunities for the use of balanced salt solutions[5].
• Collaborations and Partnerships: Collaborations among industry players to expand product portfolios and improve technology can further drive market growth[5].

Key Takeaways

• Balanced salt solutions have shown potential in reducing acute kidney injury and other complications in critically ill patients compared to saline solutions.
• The market for balanced salt solutions is growing, driven by advancements in biotechnology, the expanding pharmaceutical industry, and the increasing prevalence of chronic diseases.
• North America currently dominates the market, but the Asia Pacific region is expected to see significant growth.
• Despite the growth, the market faces restraints such as stringent regulatory requirements and high production costs.

FAQs

What are the main types of balanced salt solutions used in clinical and research settings?

The main types include Hanks' Balanced Salt Solution, Gey's Balanced Salt Solution, Earle's Balanced Salt Solution, and Dulbecco's Phosphate Buffered Saline[2].

How do balanced salt solutions compare to saline solutions in clinical trials?

Clinical trials such as the CHLORIDE, SPLIT, SMART, and BaSICS trials have shown that balanced salt solutions can reduce the incidence of acute kidney injury and other complications compared to saline solutions[1][4].

What are the key drivers of the balanced salt solutions market?

The key drivers include the growing prevalence of chronic diseases, advancements in biotechnology research, and the expanding pharmaceutical industry[5].

Which region is expected to see significant growth in the balanced salt solutions market?

The Asia Pacific region is expected to witness significant growth due to increasing investments in research and development and a growing focus on healthcare infrastructure[5].

What are some of the restraints facing the balanced salt solutions market?

The restraints include stringent regulatory requirements, high production costs, and limited awareness and adoption in certain regions[5].

Sources

1. Balanced Salt Solutions: Are We Crystal Clear or Still Murky? - Kidney News[1]
2. Balanced Salt Solutions Market - Industry Analysis Forecast 2029 - Maximize Market Research[2]
3. U.S. Clinical Trials Market Size Industry Analysis Report, 2033 - BioSpace[3]
4. Effect of Intravenous Fluid Treatment With a Balanced Solution vs ... - JAMA Network[4]
5. Balanced Salt Solutions Market 2024-2032 | Size, Share, Growth - Market Wide Research[5]

Last updated: 2025-01-03