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

Procter & Gamble (P&G)

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Drug: Prevacid; Drug: Prilosec OTC (omeprazole-magnesium)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00903448

2009010

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

A

Experimental group

Description:

Prilosec OTC

Treatment:

Drug: Prilosec OTC (omeprazole-magnesium)

B

Active Comparator group

Description:

Prevacid

Treatment:

Drug: Prevacid