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CLINICAL TRIALS PROFILE FOR AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
505(b)(2) Clinical Trials for Amino Acids; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
| 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). |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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 |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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 |
| Kidney Calculi | 2 |
| Hypercalciuria | 2 |
| Healthy | 2 |
| [disabled in preview] | 0 |
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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 |
| Bone Diseases, Metabolic | 2 |
| [disabled in preview] | 0 |
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Clinical Trial Locations for Amino Acids; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Clinical Trial Progress for Amino Acids; Magnesium Chloride; Potassium Chloride; Potassium Phosphate, Dibasic; Sodium Chloride
Clinical Trial Phase
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 |
| Active, not recruiting | 4 |
| [disabled in preview] | 7 |
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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 |
| University of California, San Francisco | 2 |
| University of Zurich | 2 |
| AstraZeneca | 2 |
| [disabled in preview] | 6 |
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Sponsor Type
