Gastric AcidPhase 3NCT00542347
Comparison of the Gastric Acid Suppressive Effects of Esomeprazole and Generic Omeprazole
A Phase 3 study testing Esomeprazole first and Generic omeprazole first in people with Gastric Acid, run by Queen's University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Acid
- What is being tested?
- Esomeprazole first and Generic omeprazole first
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2007to Jul 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy, non-smoking volunteers older than 18 years of age
Who cannot join
- history of gastrointestinal disease
- known infection
- previous eradication of Helicobacter pylori
- any prescription or over the counter antacid medication
- pregnant and lactating women
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Esomeprazole first, Generic omeprazole first
- Keywords
- gastric acid, proton pump inhibitors, omeprazole, esomeprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esomeprazole firstDrug
- 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
Generic omeprazole firstDrug
- 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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | * 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 Receives: Drug: Esomeprazole first |
| 2 | Active comparator | * 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 Receives: Drug: Generic omeprazole first |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median intragastric pH and percentage of time that intragastric pH is above 4
Measured: 24 hours
Secondary outcomes (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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionApr 2017
- Study completionJul 2018
Why it stopped: Enrollment target not met due to high number of disqualified studies.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AcidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Dr. Adriana Lazarescu, Queen's University
- Investigators
- William G Paterson, MD, Principal investigator, Queen's University, Hotel Dieu HospitalAdriana Lazarescu, MD, Principal investigator, Hotel Dieu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00542347
- Sponsor's protocol ID
- 1054-07
- Status last verified
- Jul 2018
- First submitted
- 9 Oct 2007
- Last updated
- 20 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Gastric Acid Suppressive Effects of Esomeprazole and Generic Omeprazole
- ClinicalTrials.gov ID
- NCT00542347
- Acronym / sponsor ID
- 1054-07
- Conditions
- Gastric Acid
- Keywords
- gastric acid, proton pump inhibitors, omeprazole, esomeprazole
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment target not met due to high number of disqualified studies.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Sep 2007
- Primary completion
- Apr 2017 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 11 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | 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 |
| 2 | Active comparator | 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy, non-smoking volunteers older than 18 years of age
Key exclusion criteria (5 listed)
- history of gastrointestinal disease
- known infection
- previous eradication of Helicobacter pylori
- any prescription or over the counter antacid medication
- pregnant and lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | 1 |
| 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 | Drug | 2 |
Primary outcome
Median intragastric pH and percentage of time that intragastric pH is above 4
Time frame: 24 hours
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Enrollment target not met due to high number of disqualified studies.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William G Paterson, MD principal investigator
Queen's University, Hotel Dieu Hospital
Adriana Lazarescu, MD principal investigator
Hotel Dieu Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Esomeprazole first and Generic omeprazole first in people with Gastric Acid, run by Queen's University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Enrollment target not met due to high number of disqualified studies.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median intragastric pH and percentage of time that intragastric pH is above 4 (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2018.