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Last Updated: October 31, 2020

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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.
>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.
NCT00142272 Single Dose Ciprofloxacin in the Treatment of Childhood Cholera:Randomized Controlled Clinical Trial Completed International Centre for Diarrhoeal Disease Research, Bangladesh 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.
NCT00194961 Effect of Growth Hormone on Leptin, Cytokines and Body Composition of Children With Growth Failure Due to Chronic Kidney Disease Terminated Genentech, Inc. Phase 4 1969-12-31 Circulating concentrations of cytokines, such as leptin, tumor necrosis factor-alpha and interleukins 1 and 6 are increased in patients with chronic kidney disease (CKD). In light of the increasing recognition that growth hormone receptor signaling involves cytokine pathway activation, the investigators hypothesize that maladaptation of cytokine regulation in chronic kidney disease may underlie growth failure. Secondly, they hypothesize that administration of recombinant human growth hormone (rhGH) will result in growth rate stimulation in pre-pubertal children with growth impairment due to chronic kidney disease by down regulation of the cytokine pathways. This is a non-randomized open-label study to evaluate the effect of recombinant human growth hormone on biochemical/metabolic and immunologic parameters in relation to body composition pre- and post-recombinant human growth hormone therapy of pre-pubertal growth hormone naive children. The efficacy of recombinant human growth hormone to improve growth velocity in pre-pubertal children with growth failure is a secondary objective. Fifteen children are to be studied over a six month period. Each patient will serve as his/her own control. Six months of growth data prior to study is required.
>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 14
Contrast Induced Nephropathy 14
Chronic Kidney Disease 9
Pain 7
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Condition MeSH

Condition MeSH for Sodium Bicarbonate
Intervention Trials
Kidney Diseases 37
Acute Kidney Injury 28
Renal Insufficiency 20
Renal Insufficiency, Chronic 15
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Clinical Trial Locations for Sodium Bicarbonate

Trials by Country

Trials by Country for Sodium Bicarbonate
Location Trials
United States 142
Italy 19
Brazil 14
Australia 12
Canada 10
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Trials by US State

Trials by US State for Sodium Bicarbonate
Location Trials
California 11
Missouri 8
Florida 8
Pennsylvania 8
North Carolina 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 55
Phase 3 37
Phase 2/Phase 3 10
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Clinical Trial Status

Clinical Trial Status for Sodium Bicarbonate
Clinical Trial Phase Trials
Completed 83
Recruiting 37
Not yet recruiting 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 229
Industry 46
NIH 6
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Serving leading biopharmaceutical companies globally:

Medtronic
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