Comparison of the Gastric Acid Suppressive Effects of Esomeprazole and Generic Omeprazole - Full Text View

Sponsors and Collaborators:	Queen's University CIHR
Information provided by:	Queen's University
ClinicalTrials.gov Identifier:	NCT00542347

Purpose

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.

Condition	Intervention	Phase
Gastric Acid	Drug: Esomeprazole first Drug: Generic omeprazole first	Phase III

Drug Information available for: Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Efficacy Study
Official Title:	Comparison of the Gastric Acid Suppressive Effects of Esomeprazole and Generic Omeprazole

Further study details as provided by Queen's University:

Primary Outcome Measures:

Median intragastric pH and percentage of time that intragastric pH is above 4 [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	September 2007
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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 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: Active Comparator 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 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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542347

Contacts

Contact: Jackie MacKay

(613)544-3400 ext 2440

mckayj@hdh.kari.net

Locations

Canada, Ontario
Hotel Dieu Hospital	Recruiting
Kingston, Ontario, Canada, K7L 5G2

Sponsors and Collaborators

Queen's University

CIHR

Investigators

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

More Information

Responsible Party:	Division of Gastroenterology, Queen's University ( Dr. W.G. Paterson MD )
Study ID Numbers:	1054-07
Study First Received:	October 9, 2007
Last Updated:	December 5, 2008
ClinicalTrials.gov Identifier:	NCT00542347
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Queen's University:

gastric acid
proton pump inhibitors
omeprazole
esomeprazole

Study placed in the following topic categories:

Omeprazole

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents

Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009