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

Phase 3

Terminated

• Conditions: Gastric Acid
• Interventions: Drug: Esomeprazole first; Drug: Generic omeprazole first

• Registration Number: NCT00542347
• Lead Sponsor: Queen's University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-10-09
• Study First Submitted QC: 2007-10-09
• Study First Posted: 2007-10-11
• Primary Completion: 2017-04
• Status Verified: 2018-07
• Study Completion: 2018-07
• Last Update Submitted: 2018-07-18
• Last Update Posted: 2018-07-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	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
2	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

Primary Outcome Measures

Name	Time	Method
Median intragastric pH and percentage of time that intragastric pH is above 4	24 hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hotel Dieu Hospital; 🇨🇦 Kingston, Ontario, Canada