Completed

NCT Number: NCT00808769

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

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

Completed

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Key information

Conditions

Normal Healthy Subject Population

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site

Oklahoma City, Oklahoma, 73104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zegerid®

Drug

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

Prilosec OTC®

Drug

Omeprazole-magnesium 20.6 mg, tablet, single dose

Primary outcomes

The Mean Percent Time Gastric pH > 4.0 on Day 1

Time frame: continuously over a 24 hour period

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.

Sponsors and collaborators

Lead sponsor

Procter and Gamble

Industry

Registry information

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2008
First posted: Dec 16, 2008
Registry last updated: Jun 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.