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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00808769
Recruitment Status : Completed
First Posted : December 16, 2008
Results First Posted : April 27, 2011
Last Update Posted : June 1, 2015
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Normal Healthy Subject Population Drug: Zegerid® Drug: Prilosec OTC® Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Official Title: Comparison of Prilosec OTC® Versus Zegerid® for Gastric Acid Suppression
Study Start Date : November 2008
Primary Completion Date : December 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. The Mean Percent Time Gastric pH > 4.0 on Day 1 [ Time Frame: continuously over a 24 hour period ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Procter and Gamble
ClinicalTrials.gov Identifier: NCT00808769     History of Changes
Other Study ID Numbers: 2008122
First Posted: December 16, 2008    Key Record Dates
Results First Posted: April 27, 2011
Last Update Posted: June 1, 2015
Last Verified: May 2015

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