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

Gastric Acid research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Gastric Acid

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Esomeprazole firstesomeprazole 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:Generic omeprazole firstgeneric 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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

1esomeprazole 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

2generic 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

Study Status

Recruiting

Start Date: September 2007

Completed Date: June 2017

Phase: Phase 3

Type: Interventional

Design:

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

Study sponsors, principal investigator, and references

Principal Investigator: William G Paterson, MD

Lead Sponsor: Queen's University

Collaborator: Canadian Institutes of Health Research (CIHR)

More information:https://clinicaltrials.gov/show/NCT00542347

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