Symptom Adapted Therapy in GERD Patients - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00343161

Purpose

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.

Condition	Intervention	Phase
Gastroesophageal Reflux Disease (GERD).	Drug: esomeprazole Drug: Gelusil-Lac (Aluminum hydroxide gel,magnesium trisilicate)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy 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

Resource links provided by NLM:

MedlinePlus related topics: GERD

Drug Information available for: Magnesium trisilicate Aluminum hydroxide Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium Algeldrate Aluminum Magnesium

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	441
Study Start Date:	August 2006
Study Completion Date:	October 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00343161

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Locations

Germany
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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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/Spree, 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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Zwickau, Germany
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Kehl, Germany
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Kirchlengern, Germany
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Köln, Germany
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Krefeld, Germany
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Kronach, Germany
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Kurort Oberwiesenthal, Germany
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Landau, Germany
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Leipzig, Germany
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Leverkusen, Germany
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Löbau, Germany
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Lohfelden, 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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Oettingen, 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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Isernhagen, Germany

Sponsors and Collaborators

AstraZeneca

Investigators

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

More Information

No publications provided

Study ID Numbers:	D9612L00109, SYMPATHY, EudraCT-No. 2006-001316-76
Study First Received:	June 20, 2006
Last Updated:	January 11, 2008
ClinicalTrials.gov Identifier:	NCT00343161 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:

Nexium

Additional relevant MeSH terms:

Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Adjuvants, Immunologic
Omeprazole
Enzyme Inhibitors
Gastroesophageal Reflux
Pharmacologic Actions

Aluminum Hydroxide
Esophageal Motility Disorders
Deglutition Disorders
Magnesium trisilicate
Digestive System Diseases
Therapeutic Uses
Anti-Ulcer Agents
Antacids
Esophageal Diseases

ClinicalTrials.gov processed this record on November 22, 2009