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Last Updated: November 29, 2022

CLINICAL TRIALS PROFILE FOR OMEPRAZOLE; SODIUM BICARBONATE


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505(b)(2) Clinical Trials for Omeprazole; 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 Omeprazole; 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 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.
NCT00426595 ↗ Pharmacokinetics of Enteral Omeprazole Suspension in Patients With Cerebral Palsy and Mental Retardation Completed University Hospital, Ghent Phase 2 2007-04-01 Gastroesophageal reflux disease and reflux-esophagitis are a major chronic problem in most children with cerebral palsy and mental retardation. Oral administration of enteric-coated formulations of the acid-labile proton pump inhibitor omeprazole is often problematic in these patients who may be suffering from swallowing disorders. A suspension of omeprazole in a sodium bicarbonate solution is often used for administration via the gastrostomy tube. This trial aims to compare the pharmacokinetics of omeprazole administered through the gastrostomy tube as a suspension in pediatric patients with cerebral palsy and mental retardation versus the pharmacokinetics of omeprazole administered as a multi-unit-pellet system (MUPSĀ®). The crossover study will consist of 2 consecutive treatment periods of 14 days.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Omeprazole; Sodium Bicarbonate

Condition Name

Condition Name for Omeprazole; Sodium Bicarbonate
Intervention Trials
Gastric Acid 2
Gastroesophageal Reflux 2
Human Experimentation 2
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Condition MeSH

Condition MeSH for Omeprazole; Sodium Bicarbonate
Intervention Trials
Gastroesophageal Reflux 3
Heartburn 2
Esophagitis, Peptic 2
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Clinical Trial Locations for Omeprazole; Sodium Bicarbonate

Trials by Country

Trials by Country for Omeprazole; Sodium Bicarbonate
Location Trials
United States 31
Belgium 1
Korea, Republic of 1
Poland 1
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Trials by US State

Trials by US State for Omeprazole; Sodium Bicarbonate
Location Trials
Missouri 3
Minnesota 2
North Carolina 1
Ohio 1
Oregon 1
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Clinical Trial Progress for Omeprazole; Sodium Bicarbonate

Clinical Trial Phase

Clinical Trial Phase for Omeprazole; Sodium Bicarbonate
Clinical Trial Phase Trials
Phase 4 4
Phase 3 5
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Omeprazole; Sodium Bicarbonate
Clinical Trial Phase Trials
Completed 12
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Clinical Trial Sponsors for Omeprazole; Sodium Bicarbonate

Sponsor Name

Sponsor Name for Omeprazole; Sodium Bicarbonate
Sponsor Trials
Bausch Health Americas, Inc. 5
Valeant Pharmaceuticals International, Inc. 5
Bayer 4
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Sponsor Type

Sponsor Type for Omeprazole; Sodium Bicarbonate
Sponsor Trials
Industry 16
Other 6
U.S. Fed 1
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