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

This study has been completed.
Information provided by (Responsible Party):
Procter and Gamble Identifier:
First received: December 15, 2008
Last updated: May 7, 2015
Last verified: May 2015
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
Intervention Model: Crossover Assignment
Masking: Single (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 ]
    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
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


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 identifier: NCT00808769

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

Responsible Party: Procter and Gamble Identifier: NCT00808769     History of Changes
Other Study ID Numbers: 2008122
Study First Received: December 15, 2008
Results First Received: May 19, 2010
Last Updated: May 7, 2015

Additional relevant MeSH terms:
Omeprazole, sodium bicarbonate drug combination
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017