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

Study Overview
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Brief Summary
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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.

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

Conditions
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Gastric Acid

Intervention / Treatment
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* Drug: Esomeprazole first
* Drug: Generic omeprazole first


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>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<br>* 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<br>|
| Active Comparator: 2<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median intragastric pH and percentage of time that intragastric pH is above 4 |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric acid, proton pump inhibitors, omeprazole, esomeprazole