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

NCT00542347 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-07-20

No results posted yet for this study

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.

Conditions

  • Gastric Acid

Interventions

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

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

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Queen's University

    lead OTHER

Principal Investigators

  • William G Paterson, MD · Queen's University, Hotel Dieu Hospital

  • Adriana Lazarescu, MD · Hotel Dieu Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2017-04-30
Completion
2018-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00542347 on ClinicalTrials.gov