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Last Updated: November 22, 2019

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CLINICAL TRIALS PROFILE FOR PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE

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505(b)(2) Clinical Trials for Peg-3350, Potassium 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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Peg-3350, Potassium 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 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 Peg-3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride

Condition Name

Condition Name for Peg-3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride
Intervention Trials
Contrast Induced Nephropathy 14
Acute Kidney Injury 12
Chronic Kidney Disease 9
Metabolic Acidosis 7
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Condition MeSH

Condition MeSH for Peg-3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride
Intervention Trials
Kidney Diseases 37
Acute Kidney Injury 26
Renal Insufficiency 20
Renal Insufficiency, Chronic 15
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Clinical Trial Locations for Peg-3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride

Trials by Country

Trials by Country for Peg-3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride
Location Trials
United States 136
Italy 19
Brazil 13
Australia 12
Canada 10
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Trials by US State

Trials by US State for Peg-3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride
Location Trials
California 11
North Carolina 8
Missouri 8
Florida 7
Texas 7
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Clinical Trial Progress for Peg-3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride

Clinical Trial Phase

Clinical Trial Phase for Peg-3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride
Clinical Trial Phase Trials
Phase 4 52
Phase 3 36
Phase 2/Phase 3 10
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Clinical Trial Status

Clinical Trial Status for Peg-3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride
Clinical Trial Phase Trials
Completed 81
Recruiting 33
Not yet recruiting 27
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Clinical Trial Sponsors for Peg-3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride

Sponsor Name

Sponsor Name for Peg-3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride
Sponsor Trials
Valeant Pharmaceuticals International, Inc. 5
Ospedale Misericordia e Dolce 5
Bayer 5
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Sponsor Type

Sponsor Type for Peg-3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride
Sponsor Trials
Other 209
Industry 44
NIH 6
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