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Last Updated: November 22, 2019

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CLINICAL TRIALS PROFILE FOR AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE

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505(b)(2) Clinical Trials for Amino Acids; Magnesium Chloride; Potassium Acetate; Potassium Chloride; Sodium Acetate

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 NCT04039828 Zinc Sulfate Acceptability Not yet recruiting International Centre for Diarrhoeal Disease Research, Bangladesh N/A 2019-07-01 Introduction: Zinc (Zn) is an essential mineral widely distributed within the human body with metalloproteins, Zinc-binding proteins, etc. It is necessary for signal transduction and also cell growth and proliferation via respective metallo- and zinc-dependent enzymes. Zinc supplementation can significantly reduce diarrheal severity and duration as well as prevents future incidences and reduces use of other medications in diarrhoea. For this reason WHO, UNICEF, USAID and experts worldwide jointly recommended zinc supplementation (10 mg for infants less than 6 months old and 20 mg in 6 - 59 months old) combined with reduced osmolarity ORS for clinical management of acute diarrhoea. But due to strong metallic taste zinc products are less palatable to children even after using masking flavours as recommended by WHO. Several companies have formulated the product since WHO recommendations came but still transient side effects like vomiting and regurgitation remain evident. Despite careful counselling to the caregivers expected adherence rate to 10 days regimen of zinc supplement is yet to be reached. With the aim to increase zinc supplement coverage during acute diarrheal illness, it is necessary to conduct a study to introduce new formulation Zinc tablet which is more palatable, more dispersible and more acceptable. Intervention: Zinc sulfate [Zinc Dispersible Tablet, 20 mg; (Elemental Zinc 20 mg as Zinc Sulfate Monohydrate / Tablet)] Methods: Prospective, open label, interventional study Hypothesis: Improved formulation of Zinc Sulfate will have good acceptability. Study population: Stratum 1: 3 months - <18 months = 175 children Stratum 2: 18 months - 59 months = 175 children Objectives: 1. Primary Objective: Acceptability of the zinc product in the management of childhood diarrhea will be assessed by observing: i) Incidence of vomiting or regurgitation among enrolled children receiving the improvised zinc formulation. ii) The adherence: The number of days (out of the total 10 days) the child took the protocol-prescribed dose of the medicine. The treatment will be considered to have good acceptability if at least 80% of the prescribed treatment is taken by at least 70% of the children over the duration of 10 days, as per WHO guidelines. 2. Secondary objective : To assess palatability Secondary end point evaluation (Palatability): The statistical analysis will comprise the calculation of the percentage of patients out of 350 who found the investigational product to have "very well-tolerated, well-tolerated or tolerated" scores (i.e. any of the upper 3 possible scores). A 95% confidence interval, using the normal approximation of the binomial distribution, will be calculated for the percentage.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Amino Acids; Magnesium Chloride; Potassium Acetate; Potassium Chloride; Sodium Acetate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00118482 Clinical Trial for the Prevention of Vasovagal Syncope Completed Canadian Institutes of Health Research (CIHR) Phase 4 2005-05-01 The main question in the study is whether people taking fludrocortisone are less likely to faint than people taking an inactive pill called a placebo. Fludrocortisone is a drug that stimulates the body to retain salt and water. The investigators know from some studies that it might prevent people from fainting at home and in the community, while they are carrying on with their lives. There is some evidence that salt and water retention help prevent fainting, but no one has a clear idea about whether this is true. This study will try to determine if that is true.
NCT00118482 Clinical Trial for the Prevention of Vasovagal Syncope Completed University of Calgary Phase 4 2005-05-01 The main question in the study is whether people taking fludrocortisone are less likely to faint than people taking an inactive pill called a placebo. Fludrocortisone is a drug that stimulates the body to retain salt and water. The investigators know from some studies that it might prevent people from fainting at home and in the community, while they are carrying on with their lives. There is some evidence that salt and water retention help prevent fainting, but no one has a clear idea about whether this is true. This study will try to determine if that is true.
NCT00212043 Phase I/II Trial of Infusional Gemcitabine in Combination With Carboplatin in Chemonaive Non-small Cell Carcinoma Completed Eli Lilly and Company Phase 2 2000-07-01 Hypothesis - Infusional gemcitabine may give better intracellular pharmacologic activation and be more effective clinically in non-small cell lung cancer
NCT00212043 Phase I/II Trial of Infusional Gemcitabine in Combination With Carboplatin in Chemonaive Non-small Cell Carcinoma Completed National University Hospital, Singapore Phase 2 2000-07-01 Hypothesis - Infusional gemcitabine may give better intracellular pharmacologic activation and be more effective clinically in non-small cell lung cancer
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Amino Acids; Magnesium Chloride; Potassium Acetate; Potassium Chloride; Sodium Acetate

Condition Name

Condition Name for Amino Acids; Magnesium Chloride; Potassium Acetate; Potassium Chloride; Sodium Acetate
Intervention Trials
Diabetes 2
Dentin Sensitivity 1
Metastatic Castrate-Resistant Prostate Cancer 1
Renal Failure 1
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Condition MeSH

Condition MeSH for Amino Acids; Magnesium Chloride; Potassium Acetate; Potassium Chloride; Sodium Acetate
Intervention Trials
Ketosis 2
Diabetic Ketoacidosis 2
Diarrhea 2
Cholera 1
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Clinical Trial Locations for Amino Acids; Magnesium Chloride; Potassium Acetate; Potassium Chloride; Sodium Acetate

Trials by Country

Trials by Country for Amino Acids; Magnesium Chloride; Potassium Acetate; Potassium Chloride; Sodium Acetate
Location Trials
United States 12
Canada 10
Bangladesh 2
Brazil 1
China 1
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Trials by US State

Trials by US State for Amino Acids; Magnesium Chloride; Potassium Acetate; Potassium Chloride; Sodium Acetate
Location Trials
Virginia 2
Massachusetts 2
Minnesota 1
Indiana 1
California 1
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Clinical Trial Progress for Amino Acids; Magnesium Chloride; Potassium Acetate; Potassium Chloride; Sodium Acetate

Clinical Trial Phase

Clinical Trial Phase for Amino Acids; Magnesium Chloride; Potassium Acetate; Potassium Chloride; Sodium Acetate
Clinical Trial Phase Trials
Phase 4 3
Phase 3 2
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Amino Acids; Magnesium Chloride; Potassium Acetate; Potassium Chloride; Sodium Acetate
Clinical Trial Phase Trials
Completed 5
Recruiting 4
Active, not recruiting 3
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Clinical Trial Sponsors for Amino Acids; Magnesium Chloride; Potassium Acetate; Potassium Chloride; Sodium Acetate

Sponsor Name

Sponsor Name for Amino Acids; Magnesium Chloride; Potassium Acetate; Potassium Chloride; Sodium Acetate
Sponsor Trials
International Centre for Diarrhoeal Disease Research, Bangladesh 3
National University Hospital, Singapore 1
OncoGenex Technologies 1
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Sponsor Type

Sponsor Type for Amino Acids; Magnesium Chloride; Potassium Acetate; Potassium Chloride; Sodium Acetate
Sponsor Trials
Other 20
Industry 4
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