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

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

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).

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

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004284	Phase III Randomized, Double-Blind Study of Potassium Phosphate Vs Potassium Citrate for Absorptive Hypercalciuria	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 3	1995-04-01	OBJECTIVES: I. Evaluate the ability of a slow-releasing formulation of neutral potassium phosphate to correct hypercalciuria and prevent recurrent stone formation in patients with absorptive hypercalciuria. II. Evaluate the safety of this treatment. III. Compare the efficacy of potassium phosphate to that of potassium citrate.
NCT00004284	Phase III Randomized, Double-Blind Study of Potassium Phosphate Vs Potassium Citrate for Absorptive Hypercalciuria	Completed	University of Texas	Phase 3	1995-04-01	OBJECTIVES: I. Evaluate the ability of a slow-releasing formulation of neutral potassium phosphate to correct hypercalciuria and prevent recurrent stone formation in patients with absorptive hypercalciuria. II. Evaluate the safety of this treatment. III. Compare the efficacy of potassium phosphate to that of potassium citrate.
NCT00004284	Phase III Randomized, Double-Blind Study of Potassium Phosphate Vs Potassium Citrate for Absorptive Hypercalciuria	Completed	National Center for Research Resources (NCRR)	Phase 3	1995-04-01	OBJECTIVES: I. Evaluate the ability of a slow-releasing formulation of neutral potassium phosphate to correct hypercalciuria and prevent recurrent stone formation in patients with absorptive hypercalciuria. II. Evaluate the safety of this treatment. III. Compare the efficacy of potassium phosphate to that of potassium citrate.
NCT00120731	Effects of Potassium Citrate in Urine of Children With Elevated Calcium in Urine and Kidney Stones	Completed	Children's Mercy Hospital Kansas City	N/A	2005-07-01	High amounts of calcium in the urine (hypercalciuria) can cause development of kidney stones in children. Treatment for these children includes plenty of fluids, a low-salt diet and medications such as potassium citrate. A major advantage of potassium citrate, as compared to hydrochlorothiazide, is its lack of side effects. One problem the researchers and others have observed is that some children continue to form kidney stones despite correction of hypercalciuria with potassium citrate. One possible explanation is that in some individuals potassium citrate therapy results in an excessive elevation of urine pH, a situation that may predispose to calcium phosphate stone formation. In this study, the researchers will study the effects of potassium citrate on urine chemistries and acid-base balance in three groups of children aged 5-17 years: - children who are hypercalciuric stone formers; - healthy children without a history of hypercalciuria or kidney stones. Particular attention will be paid to try to identify those who develop a very high urine pH (>8) and the factors leading to this metabolic reaction. The researchers will try to learn whether it is the child’s characteristics, the disease manifestations, the dose of the drug, or a combination of the above which may be the cause of the development of very alkaline urine. Based on the results, the researchers hope to be able to better “tailor” the individual treatment for each child with kidney stones.
NCT00291720	Is Spironolactone Safe and Effective in the Treatment of Cardiovascular Disease in Mild Chronic Renal Failure?	Completed	British Heart Foundation	Phase 2	2005-04-01	Patients with kidney failure have a poor survival rate that is due to a much higher than average rate of heart and vascular disease. The reason that kidney failure causes heart disease is unknown but recent research suggests that a hormone called aldosterone, which is increased in patients with kidney disease may damage the heart and blood vessels. The investigators propose, using a randomized blinded trial, to find out whether drugs that inhibit the actions of aldosterone have beneficial effects on the cardiovascular system in patients with kidney failure
NCT00291720	Is Spironolactone Safe and Effective in the Treatment of Cardiovascular Disease in Mild Chronic Renal Failure?	Completed	University Hospital Birmingham	Phase 2	2005-04-01	Patients with kidney failure have a poor survival rate that is due to a much higher than average rate of heart and vascular disease. The reason that kidney failure causes heart disease is unknown but recent research suggests that a hormone called aldosterone, which is increased in patients with kidney disease may damage the heart and blood vessels. The investigators propose, using a randomized blinded trial, to find out whether drugs that inhibit the actions of aldosterone have beneficial effects on the cardiovascular system in patients with kidney failure
NCT00317629	Controlled Nitric Oxide Releasing Patch Versus Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis	Terminated	Secretaria de Salud de Santander	Phase 3	2006-05-01	Cutaneous leishmaniasis is a worldwide disease, endemic in 88 countries, that has shown an increasing incidence over the last two decades. So far, pentavalent antimony compounds have been considered the treatment of choice, with a percentage of cure of about 85%. However, the high efficacy of these drugs is counteracted by their many disadvantages and adverse events. Previous studies have shown nitric oxide to be a potential alternative treatment when administered topically with no serious adverse events. However, due to the unstable nitric oxide release, the topical donors needed to be applied frequently, making the adherence to the treatment difficult. The electrospinning technique has allowed the production of a multilayer transdermal patch that produces a continuous and stable nitric oxide release. The main objective of this study is to evaluate this novel nitric oxide topical donor for the treatment of cutaneous leishmaniasis. A double-blind, randomized, double-masked, placebo-controlled clinical trial, including 620 patients from endemic areas for leishmaniasis in Colombia was designed to investigate whether this patch is as effective as meglumine antimoniate for the treatment of cutaneous leishmaniasis but with less adverse events. Subjects with ulcers characteristic of cutaneous leishmaniasis will be medically evaluated and laboratory tests and parasitological confirmation performed. After checking the inclusion/exclusion criteria, the patients will be randomly assigned to one of two groups. During 20 days Group 1 will receive simultaneously meglumine antimoniate and placebo of nitric oxide patches while Group 2 will receive placebo of meglumine antimoniate and active nitric oxide patches. During the treatment visits, the medications will be administered daily and the presence of adverse events assessed. During the follow-up, the research group will visit the patients at days 21, 45, 90 and 180. The healing process of the ulcer, the health of the participants, recidivisms and/or reinfection will also be assessed. The evolution of the ulcers will be photographically registered. In the case that the effectiveness of the patches is demonstrated, a novel and safe therapeutic alternative for one of the most important public health problems in many countries will be available to patients.

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

Condition Name

Condition Name for Amino Acids; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Intervention	Trials
Colon Cancer	2
Respiratory Distress Syndrome, Adult	2
Hypercalciuria	2
Kidney Calculi	2

Condition MeSH

Condition MeSH for Amino Acids; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Intervention	Trials
Nephrolithiasis	4
Kidney Calculi	4
Hypercalciuria	3
Respiratory Distress Syndrome, Adult	2

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

Trials by Country

Trials by Country for Amino Acids; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Location	Trials
United States	22
Canada	3
India	3
Switzerland	2
United Kingdom	2

Trials by US State

Trials by US State for Amino Acids; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Location	Trials
Maryland	3
Minnesota	3
Illinois	2
Texas	2
California	2

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

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for Amino Acids; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Clinical Trial Phase	Trials
Completed	12
Recruiting	9
Not yet recruiting	5

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

Sponsor Name

Sponsor Name for Amino Acids; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Sponsor	Trials
National Institutes of Health (NIH)	2
University of California, San Francisco	2
University of Zurich	2

Sponsor Type

Sponsor Type for Amino Acids; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Sponsor	Trials
Other	44
NIH	8
Industry	4