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

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ClinicalTrials.gov Identifier: NCT00542347
Recruitment Status : Completed
First Posted : October 11, 2007
Last Update Posted : April 6, 2018
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Dr. Adriana Lazarescu, 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.

Condition or disease Intervention/treatment Phase
Gastric Acid Drug: Esomeprazole first Drug: Generic omeprazole first Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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
Study Start Date : September 2007
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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


Locations
Canada, Ontario
Hotel Dieu Hospital
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

Responsible Party: Dr. Adriana Lazarescu, GI Fellow, Queen's University
ClinicalTrials.gov Identifier: NCT00542347     History of Changes
Other Study ID Numbers: 1054-07
First Posted: October 11, 2007    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018

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