Gastric Acid
Conditions
Keywords
gastric acid, proton pump inhibitors, omeprazole, esomeprazole
Brief 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.
Interventions
DRUGEsomeprazole 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
DRUGGeneric omeprazole 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
Sponsors
Canadian Institutes of Health Research (CIHR)
Queen's University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median intragastric pH and percentage of time that intragastric pH is above 4 | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Nocturnal acid breakthrough, defined as at least 60 continuous minutes of intragastric pH below 4 occurring between 10pm and 6 am and adverse events | 24 hours |
Countries
Canada
Outcome results
None listed