GERDPhase 4NCT00318968
Nexium RESPONSE Trial
A Phase 4 study testing Esomeprazole in people with GERD, run by AstraZeneca at 38 sites in Denmark.
Trial summary
The primary purpose of the study is to develop, and test, an algorithm for identification of responders to empirical esomeprazole treatment in general practices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GERD
- What is being tested?
- Esomeprazole
- How many people
- 1,000 participants
- Where
- 38 sitesDenmark
- Study dates
- May 2006to Nov 2007
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients attending general practice due to symptoms suggestive of acid related disease and, according to normal routine, the GP would prescribe an acid-inhibiting agent
Who cannot join
- Alarm symptoms
- Pregnancy
- Contraindications to Nexium
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
Denmark38 sites
Research Site
Aabenraa
Research Site
Aalborg
Research Site
Albek
Research Site
Ans
Research Site
Arhus C
Research Site
Bagsværd
Research Site
Birkerød
Research Site
Brønshøj
Research Site
Farum
Research Site
Fredericia
Research Site
Frederikshavn
Research Site
Frederikssund
Research Site
Gråsten
Research Site
Haslev
Research Site
Herning
Research Site
Hinnerup
Research Site
Karlslunde
Research Site
Kerteminde
Research Site
Kobenhavn K
Research Site
Kolding
Research Site
Løsning
Research Site
Middelfart
Research Site
Næstved
Research Site
Odense C
Research Site
Randers
Research Site
Rødovre Municipality
Research Site
Roskilde
Research Site
Rungsted Kyst
Research Site
Saltum
Research Site
SEBY
Research Site
Sindal
Research Site
Solrød Strand
Research Site
Svendborg
Research Site
Tåstrup
Research Site
Tønder
Research Site
Ullerslev
Research Site
Viborg
Research Site
Viby J
About this study
Official title: Development of an Algorithm for Identification of Responders to Short Term Treatment With Esomeprazole (Nexium) in Primary Care
The primary purpose of the study is to develop, and test, an algorithm for identification of responders to empirical esomeprazole treatment in general practices.
- Conditions
- GERD
- Being tested
- Esomeprazole
- Keywords
- Acid Reflux, Nexium, Esomeprazole
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsomeprazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy variable is the patient's key complaint. A patient whose key complaint has been absent for the last 24 hour of the treatment period (2 weeks +/- 2 days) is defined as a PPI responder.
Secondary outcomes (1)
To evaluate the response rate (absence of the key complaint for the last 3 days of the treatment period (2 weeks +/- 2 days)).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startMay 2006
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GERDStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Villy Meineche Schmidt, MD, Principal investigator, Charlottenlund Research SiteStig Waldorff, MD, Study director, AstraZeneca, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00318968
- Sponsor's protocol ID
- D9612L00076
- Other IDs
- RESPONSE
- Status last verified
- Jan 2009
- First submitted
- 26 Apr 2006
- Last updated
- 26 Jan 2009
- Results posted
- No
Publications
Bytzer P, Langkilde LK, Christensen E, Meineche-Schmidt V. Work productivity improvement after acid suppression in patients with uninvestigated dyspepsia. Dan Med J. 2012 Jul;59(7):A4461.
PubMed 22759841Meineche-Schmidt V, Christensen E, Bytzer P. Randomised clinical trial: identification of responders to short-term treatment with esomeprazole for dyspepsia in primary care - a randomised, placebo-controlled study. Aliment Pharmacol Ther. 2011 Jan;33(1):41-9. doi: 10.1111/j.1365-2036.2010.04501.x. Epub 2010 Oct 29.
PubMed 21083590
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Algorithm for Identification of Responders to Short Term Treatment With Esomeprazole (Nexium) in Primary Care
- ClinicalTrials.gov ID
- NCT00318968
- Acronym / sponsor ID
- D9612L00076
- Conditions
- GERD
- Keywords
- Acid Reflux, Nexium, Esomeprazole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Study completion
- Nov 2007 (actual)
- First posted
- 27 Apr 2006 (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.
The primary purpose of the study is to develop, and test, an algorithm for identification of responders to empirical esomeprazole treatment in general practices.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients attending general practice due to symptoms suggestive of acid related disease and, according to normal routine, the GP would prescribe an acid-inhibiting agent
Key exclusion criteria (3 listed)
- Alarm symptoms
- Pregnancy
- Contraindications to Nexium
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 | Drug | – |
Primary outcome
The primary efficacy variable is the patient's key complaint. A patient whose key complaint has been absent for the last 24 hour of the treatment period (2 weeks +/- 2 days) is defined as a PPI responder.
1 secondary outcome
To evaluate the response rate (absence of the key complaint for the last 3 days of the treatment period (2 weeks +/- 2 days)).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2009.
- Derived from this study: PubMed 22759841Bytzer P, Langkilde LK, Christensen E, Meineche-Schmidt V. Work productivity improvement after acid suppression in patients with uninvestigated dyspepsia. Dan Med J. 2012 Jul;59(7):A4461.
- Derived from this study: PubMed 21083590Meineche-Schmidt V, Christensen E, Bytzer P. Randomised clinical trial: identification of responders to short-term treatment with esomeprazole for dyspepsia in primary care - a randomised, placebo-controlled study. Aliment Pharmacol Ther. 2011 Jan;33(1):41-9. doi: 10.1111/j.1365-2036.2010.04501.x. Epub 2010 Oct 29.
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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.
Villy Meineche Schmidt, MD principal investigator
Charlottenlund Research Site
Stig Waldorff, MD study director
AstraZeneca, Denmark
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Esomeprazole in people with GERD, run by AstraZeneca at 38 sites in Denmark.
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 3 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: finished, as of the sponsor's last update on 26 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in Denmark. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary efficacy variable is the patient's key complaint. A patient whose key complaint has been absent for the last 24 hour of the treatment period (2 weeks +/- 2 days) is defined as a PPI responder.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00318968, which also lists 2 linked publications.
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 26 Jan 2009.