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

This study is currently recruiting participants.
Verified June 2012 by Queen's University
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Adriana Lazarescu, Queen's University
ClinicalTrials.gov Identifier:
NCT00542347
First received: October 9, 2007
Last updated: June 26, 2012
Last verified: June 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of the Gastric Acid Suppressive Effects of Esomeprazole and Generic Omeprazole

Resource links provided by NLM:

U.S. FDA Resources

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: December 2012
Estimated Primary Completion Date: December 2012 (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

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
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

No publications provided

Responsible Party: Adriana Lazarescu, GI Fellow, Queen's University
ClinicalTrials.gov Identifier: NCT00542347     History of Changes
Other Study ID Numbers: 1054-07
Study First Received: October 9, 2007
Last Updated: June 26, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Queen's University:
gastric acid
proton pump inhibitors
omeprazole
esomeprazole

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

ClinicalTrials.gov processed this record on June 17, 2013