Comparison of Prilosec OTC® Versus Zegerid® for Gastric Acid Suppression

This study is currently recruiting participants.

Verified by Procter and Gamble, December 2008

Sponsored by:	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

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

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

Further study details as provided by Procter and Gamble:

Primary Outcome Measures:

gastric pH [ Time Frame: continuously over a 24 hour period ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	November 2008
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Zegerid®	Drug: Zegerid® capsule(20 mg omeprazole/sodium bicarbonate), single dose
2: Experimental 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

Contacts

Contact: Simon H Magowan, MD

513.622.4844

Locations

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

Sponsors and Collaborators

Procter and Gamble

Investigators

Study Director:

Simon H Magowan, MD

Procter and Gamble

More Information

Responsible Party:	Procter and Gamble ( Simon H. Magowan, MD )
Study ID Numbers:	2008122
Study First Received:	December 15, 2008
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00808769
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Omeprazole
Healthy

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents

Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009