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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Efficacy Study

Study Primary Completion Date: August 2008

Intervention(s) in this Clinical Trial

• Drug: Esomeprazole 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
• Drug: Generic 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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • 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
• Active Comparator: 2
  • 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

Primary Measures

• Median intragastric pH and percentage of time that intragastric pH is above 4
  • Time Frame: 24 hours
    Safety Issue?: No

Secondary Measures

• 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
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Queen's University

Overall Clinical Trial Officials and Contacts

William G Paterson, MD Principal Investigator Queen's University, Hotel Dieu Hospital  

Overall Contact: Jackie MacKay (613)544-3400 mckayj@hdh.kari.net

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00542347

Study ID Number: 1054-07

ClinicalTrials.gov Identifier: NCT00542347

Health Authority: Canada: Ethics Review Committee