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

July 18, 2018 updated by: Dr. Adriana Lazarescu, Queen's University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Median intragastric pH and percentage of time that intragastric pH is above 4
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
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
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's University

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

October 9, 2007

First Submitted That Met QC Criteria

October 9, 2007

First Posted (Estimate)

October 11, 2007

Study Record Updates

Last Update Posted (Actual)

July 20, 2018

Last Update Submitted That Met QC Criteria

July 18, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1054-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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