Symptom Adapted Therapy in GERD Patients (SYMPATHY)

January 21, 2011 updated by: AstraZeneca

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

441

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aiterhofen, Germany
        • Research Site
      • Ansbach, Germany
        • Research Site
      • Apolda, Germany
        • Research Site
      • Bad Bramstedt, Germany
        • Research Site
      • Bad Frankenhausen, Germany
        • Research Site
      • Bad Salzuflen, Germany
        • Research Site
      • Bad Schwartau, Germany
        • Research Site
      • Baden-Baden, Germany
        • Research Site
      • Bergkamen, Germany
        • Research Site
      • Bergrheinfeld, Germany
        • Research Site
      • Berlin, Germany
        • Research Site
      • Bielefeld, Germany
        • Research Site
      • Bietigheim-Bissingen, Germany
        • Research Site
      • Blankenhain, Germany
        • Research Site
      • Bochum, Germany
        • Research Site
      • Bonn, Germany
        • Research Site
      • Burgwedel, Germany
        • Research Site
      • Dahn, Germany
        • Research Site
      • Deggendorf, Germany
        • Research Site
      • Deggingen, Germany
        • Research Site
      • Dresden, Germany
        • Research Site
      • Duisburg, Germany
        • Research Site
      • Düsseldorf, Germany
        • Research Site
      • Engstingen, Germany
        • Research Site
      • Erfurt, Germany
        • Research Site
      • Erlangen, Germany
        • Research Site
      • Essen, Germany
        • Research Site
      • Ettlingen, Germany
        • Research Site
      • Falkensee, Germany
        • Research Site
      • Freudenberg, Germany
        • Research Site
      • Fürstenwalde/Spree, Germany
        • Research Site
      • Garching, Germany
        • Research Site
      • Gefell, Germany
        • Research Site
      • Gera, Germany
        • Research Site
      • Gladbeck, Germany
        • Research Site
      • Goch, Germany
        • Research Site
      • Greven, Germany
        • Research Site
      • Gärtringen, Germany
        • Research Site
      • Görlitz, Germany
        • Research Site
      • Hamm, Germany
        • Research Site
      • Hammelburg, Germany
        • Research Site
      • Heidelberg, Germany
        • Research Site
      • Heilbronn, Germany
        • Research Site
      • Heiligenstadt, Germany
        • Research Site
      • Heroldsberg, Germany
        • Research Site
      • Herrischried, Germany
        • Research Site
      • Hoyerswerda, Germany
        • Research Site
      • Ilmenau, Germany
        • Research Site
      • Isernhagen, Germany
        • Research Site
      • Kehl, Germany
        • Research Site
      • Kirchlengern, Germany
        • Research Site
      • Krefeld, Germany
        • Research Site
      • Kronach, Germany
        • Research Site
      • Kurort Oberwiesenthal, Germany
        • Research Site
      • Köln, Germany
        • Research Site
      • Landau, Germany
        • Research Site
      • Leipzig, Germany
        • Research Site
      • Leverkusen, Germany
        • Research Site
      • Lohfelden, Germany
        • Research Site
      • Löbau, Germany
        • Research Site
      • Löhne, Germany
        • Research Site
      • Lübbecke, Germany
        • Research Site
      • Lübeck, Germany
        • Research Site
      • Magstadt, Germany
        • Research Site
      • Mülsen, Germany
        • Research Site
      • Münster, Germany
        • Research Site
      • Netphen, Germany
        • Research Site
      • Neuss, Germany
        • Research Site
      • Oettingen, Germany
        • Research Site
      • Otterbach, Germany
        • Research Site
      • Pforzheim, Germany
        • Research Site
      • Plettenberg, Germany
        • Research Site
      • Porta Westfalica, Germany
        • Research Site
      • Rehmsdorf, Germany
        • Research Site
      • Reinfeld, Germany
        • Research Site
      • Rheinmünster-Greffern, Germany
        • Research Site
      • Saarbrücken, Germany
        • Research Site
      • Schnaittenbach, Germany
        • Research Site
      • Schwerte, Germany
        • Research Site
      • Siegen, Germany
        • Research Site
      • Spalt, Germany
        • Research Site
      • Stutensee, Germany
        • Research Site
      • Sulzheim, Germany
        • Research Site
      • Teterow, Germany
        • Research Site
      • Thurnau, Germany
        • Research Site
      • Uhingen, Germany
        • Research Site
      • Urspringen, Germany
        • Reseach Site
      • Viersen, Germany
        • Research Site
      • Vilshofen, Germany
        • Research Site
      • Waghäusel, Germany
        • Research Site
      • Walsrode, Germany
        • Research Site
      • Weinheim, Germany
        • Research Site
      • Weißwasser, Germany
        • Research Site
      • Wesseling, Germany
        • Research Site
      • Wuppertal, Germany
        • Research Site
      • Zwickau, Germany
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed informed consent
  • Patients who seek medical advice in primary care for symptoms thought to be GERD-related

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Michael Höcker, MD, AstraZeneca Germany
  • Principal Investigator: Joachim Labenz, MD, Evan. Jung-Stilling-Krankenhaus, Siegen, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (ACTUAL)

August 1, 2007

Study Completion (ACTUAL)

August 1, 2007

Study Registration Dates

First Submitted

June 20, 2006

First Submitted That Met QC Criteria

June 21, 2006

First Posted (ESTIMATE)

June 22, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

January 24, 2011

Last Update Submitted That Met QC Criteria

January 21, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9612L00109
  • SYMPATHY
  • EudraCT-No. 2006-001316-76

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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