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Last Updated: September 19, 2021

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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.
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 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.
>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
Acute Kidney Injury 16
Contrast Induced Nephropathy 14
Chronic Kidney Disease 11
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Condition MeSH

Condition MeSH for Peg-3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride
Intervention Trials
Kidney Diseases 40
Acute Kidney Injury 30
Renal Insufficiency 20
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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 145
Italy 19
Brazil 14
Australia 12
Canada 11
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Trials by US State

Trials by US State for Peg-3350, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride
Location Trials
California 12
Missouri 9
Pennsylvania 8
North Carolina 8
Florida 8
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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 59
Phase 3 39
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 87
Recruiting 42
Not yet recruiting 41
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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 250
Industry 49
NIH 6
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