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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

Page last updated: August 23, 2015

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