Gastroesophageal Reflux DiseasePhase 4SYMPATHYNCT00343161
Symptom Adapted Therapy in GERD Patients
A Phase 4 study testing esomeprazole and Gelusil-Lac (Aluminum hydroxide gel,magnesium trisilicate) in people with Gastroesophageal Reflux Disease, run by AstraZeneca at 96 sites in Germany.
Trial summary
The purpose of the study is to determine whether a maintenance treatment over 12 weeks with esomeprazole 20 mg daily will sufficiently give control over GERD symptoms and how it compares either with an on-demand therapy with esomeprazole 20 mg or an as needed therapy (wait and see regimen) with rescue medication only… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- esomeprazole and Gelusil-Lac (Aluminum hydroxide gel,magnesium trisilicate)
- How many people
- 441 participants
- Where
- 96 sitesGermany
- Study dates
- Aug 2006to Aug 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Signed informed consent
- Patients who seek medical advice in primary care for symptoms thought to be GERD-related
Who cannot join
- Clinical GERD diagnosis/treatment within last 3 month
- History of severe esophagitis (i.e. LA grade C or D)
- Previous anti-reflux surgery
- History of drug abuse
- Female patients who are pregnant or lactating or at risk of pregnancy
Trial locations and contacts
96 sites in 1 country.
96 sites in 1 country
Germany96 sites
Research Site
Aiterhofen
Research Site
Ansbach
Research Site
Apolda
Research Site
Bad Bramstedt
Research Site
Bad Frankenhausen
Research Site
Bad Salzuflen
Research Site
Bad Schwartau
Research Site
Baden-Baden
Research Site
Bergkamen
Research Site
Bergrheinfeld
Research Site
Berlin
Research Site
Bielefeld
Research Site
Bietigheim-Bissingen
Research Site
Blankenhain
Research Site
Bochum
Research Site
Bonn
Research Site
Burgwedel
Research Site
Cologne
Research Site
Dahn
Research Site
Deggendorf
Research Site
Deggingen
Research Site
Dresden
Research Site
Duisburg
Research Site
Düsseldorf
Research Site
Engstingen
Research Site
Erfurt
Research Site
Erlangen
Research Site
Essen
Research Site
Ettlingen
Research Site
Falkensee
Research Site
Freudenberg
Research Site
Fürstenwalde
Research Site
Garching
Research Site
Gärtringen
Research Site
Gefell
Research Site
Gera
Research Site
Gladbeck
Research Site
Goch
Research Site
Görlitz
Research Site
Greven
Research Site
Hamm
Research Site
Hammelburg
Research Site
Heidelberg
Research Site
Heilbronn
Research Site
Heiligenstadt
Research Site
Heroldsberg
Research Site
Herrischried
Research Site
Hoyerswerda
Research Site
Ilmenau
Research Site
Isernhagen-Süd
Research Site
Kehl
Research Site
Kirchlengern
Research Site
Krefeld
Research Site
Kronach
Research Site
Landau
Research Site
Leipzig
Research Site
Leverkusen
Research Site
Löbau
Research Site
Lohfelden
Research Site
Löhne
Research Site
Lübbecke
Research Site
Lübeck
Research Site
Magstadt
Research Site
Mülsen
Research Site
Münster
Research Site
Netphen
Research Site
Neuss
Research Site
Oberwiesenthal
Research Site
Oettingen in Bayern
Research Site
Otterbach
Research Site
Pforzheim
Research Site
Plettenberg
Research Site
Porta Westfalica
Research Site
Rehmsdorf
Research Site
Reinfeld
Research Site
Rheinmünster-Greffern
Research Site
Saarbrücken
Research Site
Schnaittenbach
Research Site
Schwerte
Research Site
Siegen
Research Site
Spalt
Research Site
Stutensee
Research Site
Sulzheim
Research Site
Teterow
Research Site
Thurnau
Research Site
Uhingen
Reseach Site
Urspringen
Research Site
Viersen
Research Site
Vilshofen
Research Site
Waghäusel
Research Site
Walsrode
Research Site
Weinheim
Research Site
Weißwasser
Research Site
Wesseling
Research Site
Wuppertal
Research Site
Zwickau
About this study
Official title: A Randomized, Open, Parallel-group, Multi-national, Multi-centre, Phase IV Study to Evaluate the Efficacy of Three Different Patient Management Strategies With and Without Esomeprazole 20 mg During a 3 Months Maintenance Phase Following an Initial 4-weeks Acute Treatment Phase in Subjects With Symptoms Thought to be GERD Related
The purpose of the study is to determine whether a maintenance treatment over 12 weeks with esomeprazole 20 mg daily will sufficiently give control over GERD symptoms and how it compares either with an on-demand therapy with esomeprazole 20 mg or an as needed therapy (wait and see regimen) with rescue medication only (antacid), following a 4-weeks acute treatment phase with either esomeprazole 20 mg or esomeprazole 40 mg.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- esomeprazole, Gelusil-Lac (Aluminum hydroxide gel,magnesium trisilicate)
- Keywords
- Nexium
- 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
Gelusil-Lac (Aluminum hydroxide gel,magnesium trisilicate)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the efficacy of three different long-term treatment strategies in primary care setting
To compare treatments separately within different levels of symptom load according to clinical judgement at baseline
Number of 'treatment failures' used as primary outcome variable.
Secondary outcomes (4)
To evaluate whether the Reflux Disease Questionnaire (RDQ)used in primary care setting adds value to clinical judgement in assessing baseline symptom load
Evaluate whether the RDQ facilitates the decision on appropriate acute and maintenance treatment strategy
To assess the additional impact of a concomitant low dose acetylsalicylic acid (ASA) therapy during acute and maintenance phase with regard to efficacy
To evaluate whether there is a difference between treatment strategies with regard to patient satisfaction during maintenance phase using the GERD Impact Scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2006 (estimated)
- Study startAug 2006
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 441 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael Höcker, MD, Study director, AstraZeneca GermanyJoachim Labenz, MD, Principal investigator, Evan. Jung-Stilling-Krankenhaus, Siegen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00343161
- Sponsor's protocol ID
- D9612L00109
- Other IDs
- SYMPATHY, EudraCT-No. 2006-001316-76
- Acronym
- SYMPATHY
- Status last verified
- Jan 2011
- First submitted
- 20 Jun 2006
- Last updated
- 24 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open, Parallel-group, Multi-national, Multi-centre, Phase IV Study to Evaluate the Efficacy of Three Different Patient Management Strategies With and Without Esomeprazole 20 mg During a 3 Months Maintenance Phase Following an Initial 4-weeks Acute Treatment Phase in Subjects With Symptoms Thought to be GERD Related
- ClinicalTrials.gov ID
- NCT00343161
- Acronym / sponsor ID
- SYMPATHY / D9612L00109
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- Nexium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 441 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 22 Jun 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 purpose of the study is to determine whether a maintenance treatment over 12 weeks with esomeprazole 20 mg daily will sufficiently give control over GERD symptoms and how it compares either with an on-demand therapy with esomeprazole 20 mg or an as needed therapy (wait and see regimen) with rescue medication only (antacid), following a 4-weeks acute treatment phase with either esomeprazole 20 mg or esomeprazole 40 mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Signed informed consent
- Patients who seek medical advice in primary care for symptoms thought to be GERD-related
Key exclusion criteria (5 listed)
- Clinical GERD diagnosis/treatment within last 3 month
- History of severe esophagitis (i.e. LA grade C or D)
- Previous anti-reflux surgery
- History of drug abuse
- Female patients who are pregnant or lactating or at risk of pregnancy
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 | – |
| Gelusil-Lac (Aluminum hydroxide gel,magnesium trisilicate) | Drug | – |
Primary outcome
To compare the efficacy of three different long-term treatment strategies in primary care setting
To compare treatments separately within different levels of symptom load according to clinical judgement at baseline
Number of 'treatment failures' used as primary outcome variable.
4 secondary outcomes
To evaluate whether the Reflux Disease Questionnaire (RDQ)used in primary care setting adds value to clinical judgement in assessing baseline symptom load
Evaluate whether the RDQ facilitates the decision on appropriate acute and maintenance treatment strategy
To assess the additional impact of a concomitant low dose acetylsalicylic acid (ASA) therapy during acute and maintenance phase with regard to efficacy
To evaluate whether there is a difference between treatment strategies with regard to patient satisfaction during maintenance phase using the GERD Impact Scale
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 24 Jan 2011.
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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.
Michael Höcker, MD study director
AstraZeneca Germany
Joachim Labenz, MD principal investigator
Evan. Jung-Stilling-Krankenhaus, Siegen, Germany
96 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 and Gelusil-Lac (Aluminum hydroxide gel,magnesium trisilicate) in people with Gastroesophageal Reflux Disease, run by AstraZeneca at 96 sites in Germany.
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 2 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: finished, as of the sponsor's last update on 24 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 96 sites in Germany. 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?
To compare the efficacy of three different long-term treatment strategies in primary care setting. The study lists 3 primary outcomes in all. 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 24 Jan 2011.