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Comparison of Prilosec Over-the-counter (OTC)® Versus Prevacid® for Gastric Acid Suppression

This study has been completed.
Sponsor:
Information provided by:
Procter and Gamble
ClinicalTrials.gov Identifier:
NCT00903448
First received: May 14, 2009
Last updated: December 22, 2010
Last verified: December 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy
 Drug: Prilosec OTC (omeprazole-magnesium)
Drug: Prevacid
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Comparison of Prilosec OTC® Versus Prevacid ® for Gastric Acid Suppression

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Procter and Gamble:

Primary Outcome Measures:
  • Mean Percent Time That Gastric pH > 4.0 on Day 5 [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    for 24 hours starting Day 5 for each period


Enrollment: 40
Study Start Date: April 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Prevacid
 Drug: Prevacid
Prevacid (15 mg lansoprazole) capsule to be taken with a glass of water prior to breakfast

  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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00903448

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

No publications provided

Responsible Party: Simon H. Magowan, MD, Procter and Gamble
ClinicalTrials.gov Identifier: NCT00903448     History of Changes
Other Study ID Numbers: 2009010
Study First Received: May 14, 2009
Results First Received: August 4, 2010
Last Updated: December 22, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Procter and Gamble:
Normal Healthy Subject Population

Additional relevant MeSH terms:
Omeprazole
Lansoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
 Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 23, 2013