CLINICAL TRIALS PROFILE FOR SODIUM P.A.S.

505(b)(2) Clinical Trials for Sodium P.a.s.

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 Indication	NCT00090272 ↗	A Single Dose of a Marketed Drug Being Studied for a New Indication to Treat Surgical Site Infection Following Colorectal Surgery as Compared to a Marketed Drug Approved for This Indication (0826-039)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2002-04-01	The objective of this study is to evaluate the safety and efficacy of a one time dose of an intravenous marketed drug being evaluated for a new indication as compared to a marketed drug already approved for the prevention of surgical site infection following colorectal surgery.
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.
OTC	NCT00262145 ↗	Ability of a Tea Leaf Extracts Preparation to Slow Down Carbohydrate and Fat Absorption	Completed	NatureGen	Phase 1	2005-10-01	Objective - A variety of herbal, over-the-counter preparations of tea leaves are said to reduce the rate of absorption of fat ( allegedly via inhibition of pancreatic lipase) and carbohydrate (via inhibition of carbohydrate digestion and blocking of glucose transport by the intestinal mucosa). There has been some study of the ability of these products to reduce the blood glucose increase observed after a carbohydrate meal and to reduce blood cholesterol levels in chronic studies. The purpose of the present study is to objectively determine if one cup of "tea" made from a combination of three types of tea leaves (mulberry, black and green tea) can cause malabsorption of carbohydrate and fat taken in conjunction with the tea. Research Design - The study will consist of a double blind, placebo controlled crossover study in 20 healthy subjects. On one of two days (one week apart) the subjects will ingest a standard meal consisting of 30 g of sucrose (in the tea) and 30 g of starch in the form of white rice plus 10 g of fat as butter. To measure triglyceride absorption, each meal will also contain 250 mg of 13-C labeled triolein. Triolein is a commonly ingested fat consisting of glycerol bound to three oleic acids. 13-C is a stable (non-radioactive) isotope of carbon. On one of the test days the subjects (randomly) will concurrently consume the active preparation, a tea containing extracts of the three types of tea leave described above plus the meal, and on the other test day they will consume the meal with a liquid placebo preparation (warm water, sugar and food coloring). Subjects will provide a breath sample before and at hourly intervals for 8 hours after ingestion of the meal. Carbohydrate malabsorption will be determined by the hydrogen concentration in the breath samples and fat malabsorption by the concentration of 13-CO2 in the breath samples. Clinical Significance - An increase in breath hydrogen indicates carbohydrate malabsoption and a low 13-CO2 indicates lipid malabsorption. Objective evidence that the tea leaf extract actually induces carbohydrate and/or fat malabsorption could provide the basis for further studies.
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.
OTC	NCT00610480 ↗	Tear Film Stability After Instillation of Over-the-Counter (OTC) Artificial Drops	Completed	Investigator initiated study	N/A	2007-11-01	The goal of this research is to evaluate and compare the effectiveness of Systane® versus Optive™ on aqueous tear film stability in patients with a diagnosis of Dry Eye Syndrome and to determine the possible application for this product in the future. Systane® is marketed as over-the-counter tear lubricating therapy in the United States under the FDA monograph.

All Clinical Trials for Sodium P.a.s.

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000115 ↗	Randomized Trial of Acetazolamide for Uveitis-Associated Cystoid Macular Edema	Completed	National Eye Institute (NEI)	Phase 2	1990-12-01	To test the efficacy of acetazolamide for the treatment of uveitis-associated cystoid macular edema.
NCT00000412 ↗	Osteoporosis Prevention After Heart Transplant	Completed	Merck Sharp & Dohme Corp.	Phase 3	1997-09-01	During the first year after a heart transplant, people often rapidly lose bone from their spine and hips. About 35 percent of people who receive heart transplants will suffer broken bones during the first year after transplantation. This study will compare the safety and effectiveness of the drug alendronate (Fosamax) and the active form of vitamin D (calcitriol) in preventing bone loss at the spine and hip after a heart transplant. In this study, people who have had a successful heart transplant will receive either active alendronate and a "dummy pill" instead of calcitriol, or active calcitriol and a dummy pill instead of alendronate for the first year after their transplant, starting within 1 month after transplant surgery. We will measure bone density in the hip and spine at the start of the study and after 6 and 12 months, and will also check for broken bones in the spine. This research should lead to ways of preventing this crippling form of osteoporosis.
NCT00000412 ↗	Osteoporosis Prevention After Heart Transplant	Completed	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Phase 3	1997-09-01	During the first year after a heart transplant, people often rapidly lose bone from their spine and hips. About 35 percent of people who receive heart transplants will suffer broken bones during the first year after transplantation. This study will compare the safety and effectiveness of the drug alendronate (Fosamax) and the active form of vitamin D (calcitriol) in preventing bone loss at the spine and hip after a heart transplant. In this study, people who have had a successful heart transplant will receive either active alendronate and a "dummy pill" instead of calcitriol, or active calcitriol and a dummy pill instead of alendronate for the first year after their transplant, starting within 1 month after transplant surgery. We will measure bone density in the hip and spine at the start of the study and after 6 and 12 months, and will also check for broken bones in the spine. This research should lead to ways of preventing this crippling form of osteoporosis.
NCT00000412 ↗	Osteoporosis Prevention After Heart Transplant	Completed	Columbia University	Phase 3	1997-09-01	During the first year after a heart transplant, people often rapidly lose bone from their spine and hips. About 35 percent of people who receive heart transplants will suffer broken bones during the first year after transplantation. This study will compare the safety and effectiveness of the drug alendronate (Fosamax) and the active form of vitamin D (calcitriol) in preventing bone loss at the spine and hip after a heart transplant. In this study, people who have had a successful heart transplant will receive either active alendronate and a "dummy pill" instead of calcitriol, or active calcitriol and a dummy pill instead of alendronate for the first year after their transplant, starting within 1 month after transplant surgery. We will measure bone density in the hip and spine at the start of the study and after 6 and 12 months, and will also check for broken bones in the spine. This research should lead to ways of preventing this crippling form of osteoporosis.
NCT00000439 ↗	Drug Treatment for Alcoholics With Bipolar Disorder	Completed	University of Pittsburgh	Phase 2	2000-10-01	The purpose of this study is to test the effectiveness of sodium valproate (Depacon) in treating individuals with alcohol dependence and comorbid bipolar disorder.
NCT00000439 ↗	Drug Treatment for Alcoholics With Bipolar Disorder	Completed	National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 2	2000-10-01	The purpose of this study is to test the effectiveness of sodium valproate (Depacon) in treating individuals with alcohol dependence and comorbid bipolar disorder.

Clinical Trial Conditions for Sodium P.a.s.

Condition Name

Condition Name for Sodium P.a.s.
Intervention	Trials
Healthy	147
Heart Failure	78
Hypertension	76
Pain	59

Condition MeSH

Condition MeSH for Sodium P.a.s.
Intervention	Trials
Heart Failure	154
Diabetes Mellitus	141
Hypertension	127
Kidney Diseases	120

Clinical Trial Locations for Sodium P.a.s.

Trials by Country

Trials by Country for Sodium P.a.s.
Location	Trials
China	436
Korea, Republic of	96
Denmark	79
Netherlands	78
Belgium	73

Trials by US State

Trials by US State for Sodium P.a.s.
Location	Trials
California	357
Texas	320
New York	271
Florida	227
Pennsylvania	218

Clinical Trial Progress for Sodium P.a.s.

Clinical Trial Phase

Clinical Trial Phase for Sodium P.a.s.
Clinical Trial Phase	Trials
Phase 4	908
Phase 3	692
Phase 2/Phase 3	130

Clinical Trial Status

Clinical Trial Status for Sodium P.a.s.
Clinical Trial Phase	Trials
Completed	2047
Recruiting	452
Not yet recruiting	377

Clinical Trial Sponsors for Sodium P.a.s.

Sponsor Name

Sponsor Name for Sodium P.a.s.
Sponsor	Trials
National Cancer Institute (NCI)	92
GlaxoSmithKline	65
Pfizer	61

Sponsor Type

Sponsor Type for Sodium P.a.s.
Sponsor	Trials
Other	3864
Industry	1620
NIH	280

Clinical Trials, Market Analysis, and Projections for Sodium Phenylbutyrate and Taurursodiol

Introduction to Sodium Phenylbutyrate and Taurursodiol

Sodium phenylbutyrate and taurursodiol are two compounds that have recently garnered significant attention in the medical community, particularly for their potential in treating Amyotrophic Lateral Sclerosis (ALS). Here, we will delve into the latest clinical trial results, market analysis, and future projections for these drugs.

Clinical Trial Results: CENTAUR Trial

Overview of the CENTAUR Trial

The CENTAUR trial, led by the Northeast ALS Consortium and involving Packard medical director Jeffrey Rothstein at Johns Hopkins University, is a pivotal Phase 2 randomized clinical trial. This trial enrolled 137 patients with ALS and was conducted across 25 sites in the U.S. between June 2017 and September 2019[1].

Primary Outcomes

The primary outcome of the trial was the rate of decline in the Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R) total score from baseline through the end of the trial at week 24. Patients treated with the combination of sodium phenylbutyrate and taurursodiol showed a significantly slower functional decline compared to those on placebo. Specifically, the treated group had an average decline of -1.24 points per month on the ALSFRS-R, while the placebo group lost -1.66 points per month, a difference that was statistically significant[1].

Secondary Outcomes

Although the primary outcome was positive, secondary outcomes such as muscle strength and slow vital capacity (a measure of breathing function) did not show any significant differences between the treatment and placebo groups[1].

Mechanism of Action

Sodium Phenylbutyrate

Sodium phenylbutyrate is FDA-approved for treating urea cycle disorders by facilitating the excretion of excess nitrogen. Recent research has also highlighted its role as a chemical chaperone, which can affect protein folding and potentially mitigate the misfolding associated with neurodegenerative diseases[1].

Taurursodiol

Taurursodiol is a synthetic bile acid derivative that has been shown to reduce apoptosis (programmed cell death). The combination of sodium phenylbutyrate and taurursodiol is believed to slow neuron death by reducing endoplasmic reticulum stress and mitigating mitochondrial dysfunction[1].

Market Analysis

Current Market Context

While sodium phenylbutyrate and taurursodiol are not new compounds, their application in treating ALS is a recent development. The market for ALS treatments is relatively niche but growing due to the increasing awareness and research into neurodegenerative diseases.

Market Growth Drivers

The global clinical trials market, which includes trials for ALS treatments, is expected to grow significantly. This growth is driven by the high prevalence of chronic diseases and the increasing spending on R&D by pharmaceutical companies. The Asia Pacific region is expected to see the fastest growth in clinical trials due to the increasing prevalence of infectious and chronic diseases[3].

Competitive Landscape

The market for ALS treatments is competitive, with several pharmaceutical and biotechnology companies investing in R&D. The success of the CENTAUR trial could position sodium phenylbutyrate and taurursodiol as promising candidates, potentially attracting more investment and interest from major players in the industry.

Future Projections

Need for Phase 3 Trials

Despite the promising results from the Phase 2 trial, a larger, longer Phase 3 trial is necessary to fully evaluate the efficacy and safety of sodium phenylbutyrate and taurursodiol in a larger cohort of patients. This will help validate the early findings and provide more comprehensive data on secondary outcomes such as muscle strength and breathing function[1].

Market Potential

If the Phase 3 trials are successful, sodium phenylbutyrate and taurursodiol could become significant players in the ALS treatment market. Given the current lack of effective treatments for ALS, any drug that can slow functional decline could capture a substantial market share.

Regulatory and Approval Pathway

Both sodium phenylbutyrate and taurursodiol have already been approved by the FDA for other indications, which could streamline the regulatory approval process for their use in ALS. However, the FDA will still require robust data from Phase 3 trials to approve these drugs for ALS treatment.

Key Takeaways

• Clinical Trial Success: The CENTAUR trial showed that sodium phenylbutyrate and taurursodiol can significantly slow functional decline in ALS patients over 24 weeks.
• Mechanism of Action: The combination of these drugs reduces endoplasmic reticulum stress and mitigates mitochondrial dysfunction.
• Market Growth: The global clinical trials market is growing, driven by increasing R&D spending and the prevalence of chronic diseases.
• Future Trials: A Phase 3 trial is necessary to fully evaluate the efficacy and safety of these drugs in a larger patient cohort.
• Market Potential: Successful Phase 3 trials could position these drugs as major players in the ALS treatment market.

FAQs

1. What were the primary outcomes of the CENTAUR trial?

The primary outcome was the rate of decline in the ALSFRS-R total score, which showed a statistically significant slower decline in patients treated with sodium phenylbutyrate and taurursodiol compared to those on placebo[1].

2. How do sodium phenylbutyrate and taurursodiol work in treating ALS?

These drugs reduce endoplasmic reticulum stress and mitigate mitochondrial dysfunction, thereby slowing neuron death[1].

3. What is the current market context for ALS treatments?

The market is niche but growing due to increased awareness and research into neurodegenerative diseases. The global clinical trials market is also expanding, driven by R&D spending and the prevalence of chronic diseases[3].

4. Are there any regulatory hurdles for the approval of these drugs for ALS?

Both drugs are already FDA-approved for other indications, but robust data from Phase 3 trials will still be required for approval in ALS treatment[1].

5. What are the next steps for these drugs in clinical development?

A larger, longer Phase 3 trial is necessary to fully evaluate their efficacy and safety in a larger patient cohort[1].

Sources

1. Packard Center: New Phase 2 trial results show promise for ALS.
2. Maximize Market Research: Sodium Phosphate Market – Global Industry Analysis and Forecast.
3. Fortune Business Insights: Clinical Trials Market Size, Share, Industry Trends, Growth, 2032.
4. PubMed: A 36-week multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 clinical trial of sodium oligomannate for mild-to-moderate Alzheimer's disease.
5. ThinkDo Chemicals: Sodium Salt of Polyaspartic Acid (PASP) Market Size, Growth Forecast 2023-2030.