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

NCT ID: NCT00903448

Last Updated: 2010-12-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-06-30

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Keywords

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Normal Healthy Subject Population

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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A

Prilosec OTC

Group Type EXPERIMENTAL

Prilosec OTC (omeprazole-magnesium)

Intervention Type DRUG

Prilosec OTC (omeprazole-magnesium 20.6 mg) tablet to be taken with a glass of water prior to breakfast

B

Prevacid

Group Type ACTIVE_COMPARATOR

Prevacid

Intervention Type DRUG

Prevacid (15 mg lansoprazole) capsule to be taken with a glass of water prior to breakfast

Interventions

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Prilosec OTC (omeprazole-magnesium)

Prilosec OTC (omeprazole-magnesium 20.6 mg) tablet to be taken with a glass of water prior to breakfast

Intervention Type DRUG

Prevacid

Prevacid (15 mg lansoprazole) capsule to be taken with a glass of water prior to breakfast

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Procter and Gamble

INDUSTRY

Sponsor Role lead

Responsible Party

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Procter and Gamble

Principal Investigators

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Simon H Magowan, MD

Role: STUDY_DIRECTOR

Procter and Gamble

Locations

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Research Site

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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2009010

Identifier Type: -

Identifier Source: org_study_id