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

This study has been completed.
Sponsor:
Information provided by:
Procter and Gamble
ClinicalTrials.gov Identifier:
NCT00808769
First received: December 15, 2008
Last updated: March 29, 2011
Last verified: March 2011
  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 4

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

Resource links provided by NLM:


Further study details as provided by Procter and Gamble:

Primary Outcome Measures:
  • The Mean Percent Time Gastric pH > 4.0 on Day 1 [ Time Frame: continuously over a 24 hour period ] [ Designated as safety issue: No ]
    In this study, there was evidence of gastric pH probe failure and a high incidence of biologically improbable pH measurements (sustained pH < 1.0) that bring the validity of the results into question. The results of this study are, therefore, inconclusive.


Enrollment: 30
Study Start Date: November 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Zegerid®
Drug: Zegerid®
capsule(20 mg omeprazole/sodium bicarbonate), single dose
Experimental: 2
Prilosec OTC®
Drug: Prilosec OTC®
Omeprazole-magnesium 20.6 mg, tablet, single dose

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00808769

Locations
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
Procter and Gamble
Investigators
Study Director: John McRorie, PhD, FACG, AGAF Procter and Gamble
  More Information

No publications provided

Responsible Party: John McRorie, PhD, FACG, AGAF, Procter and Gamble
ClinicalTrials.gov Identifier: NCT00808769     History of Changes
Other Study ID Numbers: 2008122
Study First Received: December 15, 2008
Results First Received: May 19, 2010
Last Updated: March 29, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Omeprazole
Omeprazole, sodium bicarbonate drug combination
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Proton Pump Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014