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Last Updated: September 22, 2021

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CLINICAL TRIALS PROFILE FOR SODIUM BICARBONATE

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505(b)(2) Clinical Trials for Sodium Bicarbonate

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 2021-01-01 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 Sodium Bicarbonate

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 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.
NCT00142272 ↗ Single Dose Ciprofloxacin in the Treatment of Childhood Cholera:Randomized Controlled Clinical Trial Completed Bayer Phase 3 2001-05-01 The study will be conducted to compare the efficacy and safety of a single dose of ciprofloxacin oral suspension 20 mg/kg with a 3-day course of erythromycin oral suspension administered in a dose of 12.5 mg/kg every 6 hours (12 doses) in the treatment of children, aged 2-15 years with clinically severe cholera due to V. cholerae O1 or O139. We hypothesize that single dose ciprofloxacin would result in similar outcome in the clinicalcurewith that of erythromycin given in multiple doses.
NCT00142272 ↗ Single Dose Ciprofloxacin in the Treatment of Childhood Cholera:Randomized Controlled Clinical Trial Completed NEMC Phase 3 2001-05-01 The study will be conducted to compare the efficacy and safety of a single dose of ciprofloxacin oral suspension 20 mg/kg with a 3-day course of erythromycin oral suspension administered in a dose of 12.5 mg/kg every 6 hours (12 doses) in the treatment of children, aged 2-15 years with clinically severe cholera due to V. cholerae O1 or O139. We hypothesize that single dose ciprofloxacin would result in similar outcome in the clinicalcurewith that of erythromycin given in multiple doses.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Sodium Bicarbonate

Condition Name

Condition Name for Sodium Bicarbonate
Intervention Trials
Acute Kidney Injury 16
Contrast Induced Nephropathy 14
Metabolic Acidosis 11
Chronic Kidney Disease 11
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Condition MeSH

Condition MeSH for Sodium Bicarbonate
Intervention Trials
Kidney Diseases 40
Acute Kidney Injury 30
Renal Insufficiency 20
Renal Insufficiency, Chronic 18
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Clinical Trial Locations for Sodium Bicarbonate

Trials by Country

Trials by Country for Sodium Bicarbonate
Location Trials
United States 145
Italy 19
Brazil 14
Australia 12
Canada 11
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Trials by US State

Trials by US State for Sodium Bicarbonate
Location Trials
California 12
Missouri 9
Pennsylvania 8
North Carolina 8
Florida 8
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Clinical Trial Progress for Sodium Bicarbonate

Clinical Trial Phase

Clinical Trial Phase for Sodium Bicarbonate
Clinical Trial Phase Trials
Phase 4 60
Phase 3 39
Phase 2/Phase 3 10
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Clinical Trial Status

Clinical Trial Status for Sodium Bicarbonate
Clinical Trial Phase Trials
Completed 87
Not yet recruiting 42
Recruiting 42
[disabled in preview] 32
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Clinical Trial Sponsors for Sodium Bicarbonate

Sponsor Name

Sponsor Name for Sodium Bicarbonate
Sponsor Trials
Bayer 5
Valeant Pharmaceuticals International, Inc. 5
Ospedale Misericordia e Dolce 5
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Sponsor Type

Sponsor Type for Sodium Bicarbonate
Sponsor Trials
Other 251
Industry 49
NIH 7
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