Comparison of the Gastric Acid Suppressive Effects of Esomeprazole and Generic Omeprazole

Queen's University

Status and phase: Terminated; Phase 3

Conditions: Gastric Acid

Treatments: Drug: Esomeprazole first; Drug: Generic omeprazole first

Study type: Interventional

Funder types: Other

Identifiers

NCT00542347

1054-07

Details and patient eligibility

About

Proton pump inhibitors (PPI) are used to decrease stomach acid secretion. A generic form of omeprazole, one of the PPIs, is on the market. With cheaper than brand name PPIs, it is unclear whether generic omeprazole is as effective clinically. This study compares generic omeprazole with half-dose esomeprazole, the strongest brand name PPI. The half-dose esomeprazole is in fact cheaper than generic omeprazole. Healthy volunteers will take each medication in turn for 7 days and their stomach acid will be measured while taking each medication. We hypothesize that half-dose esomeprazole is better at suppressing stomach acid than generic omeprazole.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy, non-smoking volunteers older than 18 years of age

Exclusion criteria

• history of gastrointestinal disease
• known infection
• previous eradication of Helicobacter pylori
• any prescription or over the counter antacid medication
• pregnant and lactating women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

1

Active Comparator group

Description:

* esomeprazole 20mg po once per day for 7 days * 24hr pH study on day 7 * followed by washout for 7 days * generic omeprazole 20mg po once per day for 7 days * 24hr pH study on day 7

Treatment:

Drug: Esomeprazole first

2

Active Comparator group

Description:

* generic omeprazole 20mg po once per day for 7 days * 24hr pH study on day 7 * followed by washout for 7 days * esomeprazole 20mg po once per day for 7 days * 24hr pH study on day 7

Treatment:

Drug: Generic omeprazole first