A Phase 3 interventional study of Esomeprazole first and Generic omeprazole first in Gastric Acid, sponsored by Queen's University. Terminated at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-20.
Sponsored by Queen's University · Phase 3, Interventional, and Treatment
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.
Queen's University is the lead sponsor of 199 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
* 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
Drug: Esomeprazole first
* 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
Drug: Generic omeprazole first
* 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
* 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
Median intragastric pH and percentage of time that intragastric pH is above 4
Time frame: 24 hours
Nocturnal acid breakthrough, defined as at least 60 continuous minutes of intragastric pH below 4 occurring between 10pm and 6 am and adverse events
Time frame: 24 hours
This study is terminated, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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