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

Verified by: Procter and Gamble, March 2011
First Received: December 15, 2008 | Last Updated: March 29, 2011 | Phase: Phase 4 | Start Date: November 2008
Overall Status: Completed | Estimated Enrollment: 30
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The purpose of this study is to compare Prilosec OTC® and Zegerid® in their effects on gastric acid suppression...

Brief Summary

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®

Outcome Measures for this Clinical Trial

Primary Measures

  • The Mean Percent Time Gastric pH > 4.0 on Day 1
    • Time Frame: continuously over a 24 hour period
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Procter and Gamble Industry

Overall Clinical Trial Officials and Contacts

John McRorie, PhD, FACG, AGAF Study Director Procter and Gamble  

Additional Information

Information obtained from ClinicalTrials.gov on February 08, 2012

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

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00808769