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
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