Official Title: “Comparison of Prilosec OTC® Versus Zegerid® for Gastric Acid Suppression”

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

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator)

Study Primary Completion Date: December 2008

Intervention(s) in this Clinical Trial

• Drug: Zegerid®
  • capsule(20 mg omeprazole/sodium bicarbonate), single dose
• Drug: Prilosec OTC®
  • Omeprazole-magnesium 20.6 mg, tablet, single dose

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Zegerid®
• Experimental: 2
  • Prilosec OTC®

Primary Measures

• gastric pH
  • Time Frame: continuously over a 24 hour period
    Safety Issue?: No

Inclusion Criteria:

• Normal subjects who are 18-65 years of age;
• 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 or other proton pump inhibitors;
• Currently using GI medications
• GI disorder or surgery leading to impaired drug absorption

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Procter and Gamble

Overall Clinical Trial Officials and Contacts

Simon H Magowan, MD Study Director Procter and Gamble  

Information obtained from ClinicalTrials.gov on September 07, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00808769

Study ID Number: 2008122

ClinicalTrials.gov Identifier: NCT00808769

Health Authority: United States: Institutional Review Board