Comparison of Prilosec OTC® Versus Zegerid® for Gastric Acid Suppression - Full Text View

Sponsor:	Procter and Gamble
Information provided by:	Procter and Gamble
ClinicalTrials.gov Identifier:	NCT00808769

Purpose

The purpose of this study is to compare Prilosec OTC® and Zegerid® in their effects on gastric acid suppression.

Condition	Intervention	Phase
Normal Healthy Subject Population	Drug: Zegerid® Drug: Prilosec OTC®	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Investigator)
Official Title:	Comparison of Prilosec OTC® Versus Zegerid® for Gastric Acid Suppression

Resource links provided by NLM:

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by Procter and Gamble:

Primary Outcome Measures:

The Mean Percent Time Gastric pH > 4.0 on Day 1 [ Time Frame: continuously over a 24 hour period ] [ Designated as safety issue: No ]
In this study, there was evidence of gastric pH probe failure and a high incidence of biologically improbable pH measurements (sustained pH < 1.0) that bring the validity of the results into question. The results of this study are, therefore, inconclusive.

Enrollment:	30
Study Start Date:	November 2008
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Zegerid®	Drug: Zegerid® capsule(20 mg omeprazole/sodium bicarbonate), single dose
Experimental: 2 Prilosec OTC®	Drug: Prilosec OTC® Omeprazole-magnesium 20.6 mg, tablet, single dose

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

History of significant GI disease
Any significant medical illness
History of hypersensitivity, allergy or intolerance to omeprazole or other proton pump inhibitors;
Currently using GI medications
GI disorder or surgery leading to impaired drug absorption

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808769

Locations

United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States, 73104

Sponsors and Collaborators

Procter and Gamble

Investigators

Study Director:

John McRorie, PhD, FACG, AGAF

Procter and Gamble

More Information

No publications provided

Responsible Party:	John McRorie, PhD, FACG, AGAF, Procter and Gamble
ClinicalTrials.gov Identifier:	NCT00808769 History of Changes
Other Study ID Numbers:	2008122
Study First Received:	December 15, 2008
Results First Received:	May 19, 2010
Last Updated:	March 29, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Omeprazole
Omeprazole, sodium bicarbonate drug combination
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Proton Pump Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012