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
  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:


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
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: 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 July 26, 2014