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

Gastric Acid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00542347
• Other study ID #: 1054-07
• Status: Terminated
• Phase: Phase 3
• Start date: September 2007
• Est. completion date: July 2018

Study information

• Verified date: July 2018
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: July 2018
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Acid

Intervention

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
• 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

Locations

Country	Name	City	State
Canada	Hotel Dieu Hospital	Kingston	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Queen's University	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median intragastric pH and percentage of time that intragastric pH is above 4		24 hours
Secondary	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