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

Phase 4CompletedNCT00903448

Procter and Gamble40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Healthy

Interventions

Prilosec OTC (omeprazole-magnesium)DRUG

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

PrevacidDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Oklahoma City, Oklahoma, United States

Outcomes

Primary Outcomes

Mean Percent Time That Gastric pH > 4.0 on Day 5

for 24 hours starting Day 5 for each period

Time frame: 24 hours

Data from ClinicalTrials.gov

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