Symptom Adapted Therapy in GERD Patients

NCT ID: NCT00343161

Last Updated: 2011-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

441 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2007-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gastroesophageal Reflux Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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esomeprazole

Intervention Type DRUG

Gelusil-Lac (Aluminum hydroxide gel,magnesium trisilicate)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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Michael Höcker, MD

Role: STUDY_DIRECTOR

AstraZeneca Germany

Joachim Labenz, MD

Role: PRINCIPAL_INVESTIGATOR

Evan. Jung-Stilling-Krankenhaus, Siegen, Germany

Locations

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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

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Countries

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Germany

Other Identifiers

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SYMPATHY

Identifier Type: -

Identifier Source: secondary_id

EudraCT-No. 2006-001316-76

Identifier Type: -

Identifier Source: secondary_id

D9612L00109

Identifier Type: -

Identifier Source: org_study_id

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