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

Information source: Queen's University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gastric Acid

Intervention: Esomeprazole first (Drug); Generic omeprazole first (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Queen's University

Official(s) and/or principal investigator(s):
William G Paterson, MD, Principal Investigator, Affiliation: Queen's University, Hotel Dieu Hospital
Adriana Lazarescu, MD, Principal Investigator, Affiliation: Hotel Dieu Hospital

Overall contact:
Jackie MacKay, Phone: (613)544-3400, Ext: 2440, Email: mckayj@hdh.kari.net

Summary

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.

Clinical Details

Official title: Comparison of the Gastric Acid Suppressive Effects of Esomeprazole and Generic Omeprazole

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Median intragastric pH and percentage of time that intragastric pH is above 4

Secondary outcome: Nocturnal acid breakthrough, defined as at least 60 continuous minutes of intragastric pH below 4 occurring between 10pm and 6 am and adverse events

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Jackie MacKay, Phone: (613)544-3400, Ext: 2440, Email: mckayj@hdh.kari.net

Hotel Dieu Hospital, Kingston, Ontario K7L 5G2, Canada; Recruiting
Additional Information

Starting date: September 2007
Last updated: May 21, 2015

Page last updated: August 23, 2015

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