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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014