Comparison of Prilosec OTC® Versus Zegerid® for Gastric Acid Suppression
Phase 4
Completed
- Conditions
- Normal Healthy Subject Population
- Interventions
- Registration Number
- NCT00808769
- Lead Sponsor
- Procter and Gamble
- Brief Summary
The purpose of this study is to compare Prilosec OTC® and Zegerid® in their effects on gastric acid suppression.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 Zegerid® Zegerid® 2 Prilosec OTC® Prilosec OTC®
- Primary Outcome Measures
Name Time Method The Mean Percent Time Gastric pH > 4.0 on Day 1 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Research Site
🇺🇸Oklahoma City, Oklahoma, United States
Research Site🇺🇸Oklahoma City, Oklahoma, United States