Comparison of Prilosec Over-the-counter (OTC)® Versus Prevacid® 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. Identifier: NCT00903448
Recruitment Status : Completed
First Posted : May 18, 2009
Results First Posted : November 22, 2010
Last Update Posted : December 31, 2010
Information provided by:
Procter and Gamble

Brief Summary:
The objective of this study is to compare Prilosec OTC® to Prevacid® for gastric acid suppression.

Condition or disease Intervention/treatment Phase
Healthy Drug: Prilosec OTC (omeprazole-magnesium) Drug: Prevacid Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Comparison of Prilosec OTC® Versus Prevacid ® for Gastric Acid Suppression
Study Start Date : April 2009
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A
Prilosec OTC
Drug: Prilosec OTC (omeprazole-magnesium)
Prilosec OTC (omeprazole-magnesium 20.6 mg) tablet to be taken with a glass of water prior to breakfast

Active Comparator: B
Drug: Prevacid
Prevacid (15 mg lansoprazole) capsule to be taken with a glass of water prior to breakfast

Primary Outcome Measures :
  1. Mean Percent Time That Gastric pH > 4.0 on Day 5 [ Time Frame: 24 hours ]
    for 24 hours starting Day 5 for each period

Information from the National Library of Medicine

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

Inclusion Criteria:

  • normal subjects who are age 18-65
  • generally healthy
  • 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, lansoprazole or other proton pump inhibitors
  • currently using GI medications
  • GI disorder or surgery leading to impaired drug absorption

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 identifier (NCT number): NCT00903448

United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
Procter and Gamble
Study Director: Simon H Magowan, MD Procter and Gamble

Responsible Party: Simon H. Magowan, MD, Procter and Gamble Identifier: NCT00903448     History of Changes
Other Study ID Numbers: 2009010
First Posted: May 18, 2009    Key Record Dates
Results First Posted: November 22, 2010
Last Update Posted: December 31, 2010
Last Verified: December 2010

Keywords provided by Procter and Gamble:
Normal Healthy Subject Population

Additional relevant MeSH terms:
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action