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

Phase 4CompletedNCT00808769

Procter and Gamble30 enrolled

Overview

The purpose of this study is to compare Prilosec OTC® and Zegerid® in their effects on gastric acid suppression.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

Conditions

Normal Healthy Subject Population

Interventions

Zegerid®DRUG

capsule(20 mg omeprazole/sodium bicarbonate), single dose

Prilosec OTC®DRUG

Omeprazole-magnesium 20.6 mg, tablet, single dose

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Normal subjects who are 18-65 years of age; * 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 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

The Mean Percent Time Gastric pH > 4.0 on Day 1

In this study, there was evidence of gastric pH probe failure and a high incidence of biologically improbable pH measurements (sustained pH \< 1.0) that bring the validity of the results into question. The results of this study are, therefore, inconclusive.

Time frame: continuously over a 24 hour period

Data from ClinicalTrials.gov

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