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Last Updated: November 27, 2021

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

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505(b)(2) Clinical Trials for MAGNESIUM CHLORIDE; SODIUM BICARBONATE; 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
OTC NCT01077076 ↗ Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole (P07812) (COMPLETED) Completed Bayer Phase 3 2008-12-01 This randomized, crossover study is to evaluate the early effectiveness, defined as effect on intragastric pH during the first 4 hours after dosing, of Zegerid, Prilosec over-the-counter (OTC) Tablets, and placebo on the 4th day of treatment to inhibit acid secretion. Additional purposes are to: 1. provide pharmacodynamic evidence comparing 24-hr inhibition of acid secretion on the 1st, 4th, and 11th days of dosing with each of the indicated treatments; 2. compare Zegerid and Prilosec OTC for achieving their steady-state effects for controlling 24-hr gastric acidity at steady-state on the 4th and 11th day of dosing. 3. evaluate early effectiveness, defined as effect on intragastric pH during the first 4 hours after administration, of Zegerid, Prilosec OTC Tablets, and placebo on acid inhibition at steady-state when administered on the 11th day of dosing.
OTC NCT04651088 ↗ Comparing Alkalinizing Agents Efficacy on Stone Risk in Patients on a Metabolically Controlled Diet Not yet recruiting University of Texas Southwestern Medical Center Early Phase 1 2021-12-01 The purpose of this study is to compare over the counter and alternative prescription urinary alkalinizing agents to slow release potassium citrate in their ability to modify urinary parameters associated with stone formation.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00045799 ↗ Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill Completed Bausch Health Americas, Inc. Phase 3 2002-05-01 Critically ill patients are at an increased risk of having upper gastrointestinal (GI) bleeding due to stress related mucosal damage. Cimetidine, delivered continuously through intravenous infusion, is the only drug that the FDA has approved for the prevention of upper GI bleeding in critically ill patients. The present trial is intended to assess the safety and efficacy of an omeprazole sodium bicarbonate immediate-release suspension in this indication.
NCT00045799 ↗ Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill Completed Valeant Pharmaceuticals International, Inc. Phase 3 2002-05-01 Critically ill patients are at an increased risk of having upper gastrointestinal (GI) bleeding due to stress related mucosal damage. Cimetidine, delivered continuously through intravenous infusion, is the only drug that the FDA has approved for the prevention of upper GI bleeding in critically ill patients. The present trial is intended to assess the safety and efficacy of an omeprazole sodium bicarbonate immediate-release suspension in this indication.
NCT00130598 ↗ PROVOCATION Trial - PROphylactic intraVenOus Hydration for Contrast Agent Toxicity PreventION Completed Swiss National Science Foundation Phase 2/Phase 3 2005-06-01 Contrast nephropathy (CN) remains a common complication of radiographic procedures and an important cause of hospital-acquired acute renal failure. Only hydration with saline is uniformly accepted and used in clinical practice as a cornerstone for the prevention of CN. But the optimal preventive strategy for CN is not known. Sodium bicarbonate might be even more effective than hydration with sodium chloride for prophylaxis of CN. Therefore the aim of the study is to evaluate the efficacy of two regimens of sodium bicarbonate compared with a prolonged infusion of sodium chloride in the prevention of CN. Primary endpoint: Decrease in glomerular filtration rate (GFR) within 48 hours.
NCT00130598 ↗ PROVOCATION Trial - PROphylactic intraVenOus Hydration for Contrast Agent Toxicity PreventION Completed University Hospital, Basel, Switzerland Phase 2/Phase 3 2005-06-01 Contrast nephropathy (CN) remains a common complication of radiographic procedures and an important cause of hospital-acquired acute renal failure. Only hydration with saline is uniformly accepted and used in clinical practice as a cornerstone for the prevention of CN. But the optimal preventive strategy for CN is not known. Sodium bicarbonate might be even more effective than hydration with sodium chloride for prophylaxis of CN. Therefore the aim of the study is to evaluate the efficacy of two regimens of sodium bicarbonate compared with a prolonged infusion of sodium chloride in the prevention of CN. Primary endpoint: Decrease in glomerular filtration rate (GFR) within 48 hours.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

Condition Name

Condition Name for MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
Intervention Trials
Acute Kidney Injury 16
Contrast Induced Nephropathy 15
Chronic Kidney Disease 12
Metabolic Acidosis 12
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Condition MeSH

Condition MeSH for MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
Intervention Trials
Kidney Diseases 43
Acute Kidney Injury 30
Renal Insufficiency 20
Renal Insufficiency, Chronic 19
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Clinical Trial Locations for MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

Trials by Country

Trials by Country for MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
Location Trials
United States 188
Italy 19
Brazil 14
Australia 12
Canada 11
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Trials by US State

Trials by US State for MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
Location Trials
California 14
New York 11
Texas 11
North Carolina 11
Florida 10
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Clinical Trial Progress for MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

Clinical Trial Phase

Clinical Trial Phase for MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
Clinical Trial Phase Trials
Phase 4 63
Phase 3 37
Phase 2/Phase 3 11
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Clinical Trial Status

Clinical Trial Status for MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
Clinical Trial Phase Trials
Completed 135
Unknown status 30
Recruiting 19
[disabled in preview] 19
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Clinical Trial Sponsors for MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE

Sponsor Name

Sponsor Name for MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
Sponsor Trials
Bausch Health Americas, Inc. 5
Valeant Pharmaceuticals International, Inc. 5
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 5
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Sponsor Type

Sponsor Type for MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
Sponsor Trials
Other 271
Industry 59
NIH 11
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