Symptom Adapted Therapy in GERD Patients
SYMPATHY
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
3 other identifiers
interventional
441
1 country
96
Brief 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 (antacid), following a 4-weeks acute treatment phase with either esomeprazole 20 mg or esomeprazole 40 mg.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2006
Shorter than P25 for phase_4
96 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2006
CompletedFirst Posted
Study publicly available on registry
June 22, 2006
CompletedStudy Start
First participant enrolled
August 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedJanuary 24, 2011
January 1, 2011
1 year
June 20, 2006
January 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Interventions
Eligibility Criteria
You may qualify if:
- Signed informed consent
- Patients who seek medical advice in primary care for symptoms thought to be GERD-related
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (96)
Research Site
Aiterhofen, Germany
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Ansbach, Germany
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Apolda, Germany
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Bad Bramstedt, Germany
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Bad Frankenhausen, Germany
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Bad Salzuflen, Germany
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Bad Schwartau, Germany
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Baden-Baden, Germany
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Bergkamen, Germany
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Bergrheinfeld, Germany
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Berlin, Germany
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Bielefeld, Germany
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Bietigheim-Bissingen, Germany
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Blankenhain, Germany
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Bochum, Germany
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Bonn, Germany
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Burgwedel, Germany
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Cologne, Germany
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Dahn, Germany
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Deggendorf, Germany
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Deggingen, Germany
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Dresden, Germany
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Duisburg, Germany
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Düsseldorf, Germany
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Engstingen, Germany
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Erfurt, Germany
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Erlangen, Germany
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Essen, Germany
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Ettlingen, Germany
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Falkensee, Germany
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Freudenberg, Germany
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Fürstenwalde, Germany
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Garching, Germany
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Gärtringen, Germany
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Gefell, Germany
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Gera, Germany
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Gladbeck, Germany
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Goch, Germany
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Görlitz, Germany
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Greven, Germany
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Hamm, Germany
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Hammelburg, Germany
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Heidelberg, Germany
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Heilbronn, Germany
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Heiligenstadt, Germany
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Heroldsberg, Germany
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Herrischried, Germany
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Hoyerswerda, Germany
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Ilmenau, Germany
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Isernhagen-Süd, Germany
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Kehl, Germany
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Kirchlengern, Germany
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Krefeld, Germany
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Kronach, Germany
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Landau, Germany
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Leipzig, Germany
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Leverkusen, Germany
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Lohfelden, Germany
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Löbau, Germany
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Löhne, Germany
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Lübbecke, Germany
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Lübeck, Germany
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Magstadt, Germany
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Mülsen, Germany
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Münster, Germany
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Netphen, Germany
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Neuss, Germany
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Oberwiesenthal, Germany
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Oettingen in Bayern, Germany
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Otterbach, Germany
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Pforzheim, Germany
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Plettenberg, Germany
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Porta Westfalica, Germany
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Rehmsdorf, Germany
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Reinfeld, Germany
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Rheinmünster-Greffern, Germany
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Saarbrücken, Germany
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Schnaittenbach, Germany
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Schwerte, Germany
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Siegen, Germany
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Spalt, Germany
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Stutensee, Germany
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Sulzheim, Germany
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Teterow, Germany
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Thurnau, Germany
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Uhingen, Germany
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Urspringen, Germany
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Viersen, Germany
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Vilshofen, Germany
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Waghäusel, Germany
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Walsrode, Germany
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Weinheim, Germany
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Weißwasser, Germany
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Wesseling, Germany
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Wuppertal, Germany
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Zwickau, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michael Höcker, MD
AstraZeneca Germany
- PRINCIPAL INVESTIGATOR
Joachim Labenz, MD
Evan. Jung-Stilling-Krankenhaus, Siegen, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 20, 2006
First Posted
June 22, 2006
Study Start
August 1, 2006
Primary Completion
August 1, 2007
Study Completion
August 1, 2007
Last Updated
January 24, 2011
Record last verified: 2011-01