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

May 7, 2015 updated by: Procter and Gamble
The purpose of this study is to compare Prilosec OTC® and Zegerid® in their effects on gastric acid suppression.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
continuously over a 24 hour period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Procter and Gamble

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

December 15, 2008

First Submitted That Met QC Criteria

December 15, 2008

First Posted (Estimate)

December 16, 2008

Study Record Updates

Last Update Posted (Estimate)

June 1, 2015

Last Update Submitted That Met QC Criteria

May 7, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008122

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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