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

Tracking Information

First Received Date ^ICMJE

May 14, 2009

Last Updated Date

December 22, 2010

Start Date ^ICMJE

April 2009

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

mean percent time that gastric pH > 4.0 on Day 5 [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00903448 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: Prilosec OTC (omeprazole-magnesium)
Prilosec OTC (omeprazole-magnesium 20.6 mg) tablet to be taken with a glass of water prior to breakfast
Drug: Prevacid
Prevacid (15 mg lansoprazole) capsule to be taken with a glass of water prior to breakfast

Study Arm (s)

Experimental: A
Prilosec OTC

Intervention: Drug: Prilosec OTC (omeprazole-magnesium)
Active Comparator: B
Prevacid

Intervention: Drug: Prevacid

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2009

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00903448

Other Study ID Numbers ^ICMJE

2009010

Has Data Monitoring Committee

Responsible Party

Simon H. Magowan, MD, Procter and Gamble

Study Sponsor ^ICMJE

Procter and Gamble

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Simon H Magowan, MD

Procter and Gamble

Information Provided By

Procter and Gamble

Verification Date

December 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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