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

Phase 4

Completed

• Conditions: Healthy
• Interventions: Drug: Prilosec OTC (omeprazole-magnesium); Drug: Prevacid

• Registration Number: NCT00903448
• Lead Sponsor: Procter and Gamble

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-05-14
• Study First Submitted QC: 2009-05-15
• Study First Posted: 2009-05-18
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Results First Submitted: 2010-08-04
• Results First Submitted QC: 2010-10-22
• Results First Posted: 2010-11-22
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-22
• Last Update Posted: 2010-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	Prilosec OTC (omeprazole-magnesium)	Prilosec OTC
B	Prevacid	Prevacid

Primary Outcome Measures

Name	Time	Method
Mean Percent Time That Gastric pH > 4.0 on Day 5	24 hours	for 24 hours starting Day 5 for each period

Trial Locations

Locations (1)

Research Site; 🇺🇸 Oklahoma City, Oklahoma, United States