We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified December 2016 by Dr. Adriana Lazarescu, Queen's University
Sponsor:
ClinicalTrials.gov Identifier:
NCT00542347
First Posted: October 11, 2007
Last Update Posted: December 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Dr. Adriana Lazarescu, Queen's University
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of the Gastric Acid Suppressive Effects of Esomeprazole and Generic Omeprazole

Resource links provided by NLM:


Further study details as provided by Dr. Adriana Lazarescu, Queen's University:

Primary Outcome Measures:
  • Median intragastric pH and percentage of time that intragastric pH is above 4 [ Time Frame: 24 hours ]

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 ]

Estimated Enrollment: 20
Study Start Date: September 2007
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Canadian Institutes of Health Research (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: Dr. Adriana Lazarescu, GI Fellow, Queen's University
ClinicalTrials.gov Identifier: NCT00542347     History of Changes
Other Study ID Numbers: 1054-07
First Submitted: October 9, 2007
First Posted: October 11, 2007
Last Update Posted: December 19, 2016
Last Verified: December 2016

Keywords provided by Dr. Adriana Lazarescu, Queen's University:
gastric acid
proton pump inhibitors
omeprazole
esomeprazole

Additional relevant MeSH terms:
Omeprazole
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action