Comparison of Prilosec Over-the-counter (OTC)® Versus Prevacid® for Gastric Acid Suppression
Information source: Procter and Gamble
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Prilosec OTC (omeprazole-magnesium) (Drug); Prevacid (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Procter and Gamble Official(s) and/or principal investigator(s): Simon H Magowan, MD, Study Director, Affiliation: Procter and Gamble
Summary
The objective of this study is to compare Prilosec OTC® to Prevacid® for gastric acid
suppression.
Clinical Details
Official title: Comparison of Prilosec OTC® Versus Prevacid ® for Gastric Acid Suppression
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Primary outcome: Mean Percent Time That Gastric pH > 4.0 on Day 5
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- normal subjects who are age 18-65
- generally healthy
- non-childbearing potential females or those using birth control
Exclusion Criteria:
- history of significant GI disease
- any significant medical illness
- history of hypersensitivity, allergy or intolerance to omeprazole, lansoprazole or
other proton pump inhibitors
- currently using GI medications
- GI disorder or surgery leading to impaired drug absorption
Locations and Contacts
Research Site, Oklahoma City, Oklahoma 73104, United States
Additional Information
Starting date: April 2009
Last updated: December 22, 2010
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