CLINICAL TRIALS PROFILE FOR SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE

All Clinical Trials for Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01928082 ↗	The Effects of Estrogen Replacement Therapy in Postmenopausal Women With Hypercalciuria and Low Bone Mass	Terminated	University of Chicago	Phase 2	2013-08-01	The purpose of this study is to assess if estrogen replacement normalizes urinary calcium excretion in postmenopausal women with hypercalciuria and low bone mass and to assess for differences in response to estrogen replacement in women with familial hypercalciuria compared to nonfamilial hypercalciuria.
NCT02124447 ↗	Single Center Comparison of 4 FDA Approved, Commercially Available Bowel Purgatives for Colonoscopy	Withdrawn	Medical College of Wisconsin	N/A	2014-06-01	This will be a 4-way comparison to prospectively evaluate the efficacy and patient tolerability of four commercially available bowel preparations among patients undergoing colonoscopy for screening and surveillance in a single tertiary academic medical center.
NCT02523911 ↗	Efficacy and Tolerability of Suprep With and Without Simethicone for Routine Colonoscopy for Colorectal Cancer Screening	Withdrawn	Mercy Medical Center, Des Moines, Iowa	N/A	2016-03-01	The purpose of this study is to investigate Suprep bowel preparation, with and without the anti-gas medication simethicone, in terms of efficacy and patient tolerability in the preparation of patients undergoing routine colonoscopy for colorectal cancer screening.
NCT02523911 ↗	Efficacy and Tolerability of Suprep With and Without Simethicone for Routine Colonoscopy for Colorectal Cancer Screening	Withdrawn	MercyOne Des Moines Medical Center	N/A	2016-03-01	The purpose of this study is to investigate Suprep bowel preparation, with and without the anti-gas medication simethicone, in terms of efficacy and patient tolerability in the preparation of patients undergoing routine colonoscopy for colorectal cancer screening.
NCT03299452 ↗	Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor	Unknown status	Alphacait, LLC	Phase 2	2017-01-01	This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on Alphacait screening system in subjects with advanced malignant tumor.
NCT03299452 ↗	Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor	Unknown status	Haining Health-Coming Biotech Co., Ltd.	Phase 2	2017-01-01	This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on Alphacait screening system in subjects with advanced malignant tumor.

Clinical Trial Conditions for Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate

Condition Name

Condition Name for Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate
Intervention	Trials
Colonoscopy	1
Colorectal Cancer	1
Colorectal Disorders	1
Hypercalciuria	1

Condition MeSH

Condition MeSH for Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate
Intervention	Trials
Colonic Diseases	1
Neoplasm Metastasis	1
Colorectal Neoplasms	1
Osteoporosis	1

Clinical Trial Locations for Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate

Trials by Country

Trials by Country for Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate
Location	Trials
United States	5
China	3
Russian Federation	1

Trials by US State

Trials by US State for Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate
Location	Trials
Utah	1
Iowa	1
Florida	1
Wisconsin	1
Illinois	1

Clinical Trial Progress for Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate

Clinical Trial Phase

Clinical Trial Phase for Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	2
Phase 2	2

Clinical Trial Status

Clinical Trial Status for Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate
Clinical Trial Phase	Trials
Not yet recruiting	3
Withdrawn	2
Recruiting	2

Clinical Trial Sponsors for Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate

Sponsor Name

Sponsor Name for Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate
Sponsor	Trials
Medical College of Wisconsin	1
First affiliated hospital of Nanchang University	1
Joshua Stern	1

Sponsor Type

Sponsor Type for Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate
Sponsor	Trials
Other	24
Industry	2

Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate: Clinical Trials, Market Analysis, and Projections

Introduction

Sodium sulfate, potassium sulfate, and magnesium sulfate are commonly used in medical preparations, particularly for bowel cleansing prior to colonoscopy. This article delves into the clinical trials, market analysis, and future projections for these compounds.

Clinical Trials and Efficacy

Adult Studies

The efficacy of the combination of sodium sulfate, potassium sulfate, and magnesium sulfate (often referred to as Suprep Bowel Prep Kit) has been well-established in adults through several clinical trials. These trials have shown that the combination is effective in preparing the bowel for colonoscopy, with outcomes comparable to or even surpassing those of traditional polyethylene glycol (PEG) solutions[4][5].

Pediatric Studies

In pediatric patients, a single controlled clinical trial demonstrated that Suprep was effective and well-tolerated. The study, which compared Suprep to an approved comparator (NuLytely), showed that Suprep had numerically greater efficacy, although a powered noninferiority trial was not feasible due to the infrequent nature of colonoscopies in pediatric patients. The 4.5 oz dosage was recommended for approval due to its comparable efficacy and better tolerability compared to the 6 oz dosage[1].

Patient Tolerability

A prospective study comparing the efficacy and tolerability of the MSSSPS (Magnesium Sulfate, Sodium Sulfate, and Potassium Sulfate) concentrate oral solution to PEG solution found that patients preferred the MSSSPS preparation due to its easier administration, less frequent bowel movements, and better taste. The study also indicated that the overall quality of colon cleansing was similar between the two groups, with no clinically significant adverse effects observed[5].

Safety Profile

Adverse Reactions

Clinical trials have identified common adverse reactions associated with the use of sodium sulfate, potassium sulfate, and magnesium sulfate, including overall discomfort, abdominal distention, abdominal pain, nausea, vomiting, and headache. Less common adverse reactions include atrioventricular (AV) block and increased creatine kinase (CK) levels[4].

Benefit-Risk Assessment

The benefit-risk assessment for Suprep indicates that the benefits of using this combination for bowel preparation outweigh the risks. The efficacy and tolerability of the lower dose (4.5 oz) make it a preferred option, especially in pediatric patients[1].

Market Analysis

Sodium Sulfate Market

The global sodium sulfate market is expected to grow significantly, driven by its applications in various industries such as textiles, construction, and chemical manufacturing. The market size was USD 1.20 billion in 2022 and is projected to reach USD 1.85 billion by 2032, with a CAGR of 4.5% during the forecast period[2].

Related Markets

While the specific market for sodium sulfate, potassium sulfate, and magnesium sulfate in bowel prep kits is not separately quantified, their use is integral to the broader gastrointestinal preparation market. The demand for these compounds is influenced by the increasing number of colonoscopies and the preference for effective and well-tolerated bowel preparation solutions.

Market Projections

Growth Drivers

The growth of the market for sodium sulfate, potassium sulfate, and magnesium sulfate is driven by several factors:

• Increasing Colonoscopy Procedures: The rising incidence of gastrointestinal diseases and the importance of early detection through colonoscopy are driving the demand for effective bowel preparation solutions.
• Industrial Applications: Beyond medical use, these compounds have significant applications in industries such as textiles and construction, contributing to their overall market growth[2].
• Patient Preference: The better tolerability and ease of administration of MSSSPS solutions compared to traditional PEG solutions are likely to increase their adoption[5].

Future Outlook

Given the projected growth in the sodium sulfate market and the increasing demand for effective bowel preparation solutions, it is likely that the combination of sodium sulfate, potassium sulfate, and magnesium sulfate will continue to play a significant role in the medical and industrial sectors. The market is expected to expand as new applications and formulations are developed.

Key Takeaways

• Clinical Efficacy: The combination of sodium sulfate, potassium sulfate, and magnesium sulfate has been proven effective in both adult and pediatric patients for bowel preparation.
• Patient Tolerability: These compounds are well-tolerated, with patients preferring them over traditional PEG solutions due to ease of administration and better taste.
• Market Growth: The global sodium sulfate market is projected to grow at a CAGR of 4.5% from 2022 to 2032, driven by various industrial and medical applications.
• Safety Profile: While common adverse reactions exist, the benefit-risk assessment indicates that the benefits of using these compounds outweigh the risks.

FAQs

What are the common adverse reactions associated with sodium sulfate, potassium sulfate, and magnesium sulfate?

Common adverse reactions include overall discomfort, abdominal distention, abdominal pain, nausea, vomiting, and headache. Less common reactions include AV block and increased CK levels[4].

How do these compounds compare to traditional PEG solutions in terms of efficacy and tolerability?

Studies have shown that the combination of sodium sulfate, potassium sulfate, and magnesium sulfate is as effective as PEG solutions and is often better tolerated by patients, with easier administration and better taste[5].

What is the projected market size for sodium sulfate by 2032?

The global sodium sulfate market is expected to reach USD 1.85 billion by 2032, growing at a CAGR of 4.5% from 2022[2].

Are these compounds used in any other industries besides medical?

Yes, sodium sulfate, potassium sulfate, and magnesium sulfate have significant applications in industries such as textiles, construction, and chemical manufacturing[2].

What is the recommended dosage for pediatric patients undergoing bowel preparation?

The recommended dosage for pediatric patients is 4.5 oz, which has been shown to be as effective as the 6 oz dosage but better tolerated[1].

Sources

1. FDA: NDA/BLA Multi-Disciplinary Review and Evaluation (Suprep Bowel Prep Kit)[1]
2. EINPresswire: Sodium Sulfate market Size In 2024 - 2032 : Trends, Top Companies[2]
3. Fact.MR: Ammonium Sulfate Market Size, Demand & Growth Report 2024 to 2034[3]
4. DailyMed: Label: SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE[4]
5. Gut: Efficacy and patient tolerability of magnesium sulfate, sodium sulfate and potassium sulfate (MSSSPS) concentrate oral solution compared to Polyethylene Glycol (PEG) solution for colonoscopy bowel preparation[5]