GERD Treatment: SYMPATHY-Symptom Adapted Therapy in GERD Patients

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: Germany- Gelusil-Lac (Aluminium hydroxide gel, magnesium trisilicate)  Drug: Portugal- Vingel (aluminium hydroxide, dimeticone, magnesium hydroxide)  Drug: Greece- Aludrox (Aluminium hydroxide gel)	Phase IV

Further study details as provided by AstraZeneca:

Primary Outcomes: 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: 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
Expected Total Enrollment:  7600

Ages Eligible for Study:  18 Years   -   55 Years,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00343161

AstraZeneca Germany Clinical Study Information      +49-4103-7080 
AstraZeneca Greece Clinical Study Information      +30-210-6871500 

Germany
      Research Site, Aiterhofen,  Germany; Recruiting
      Research Site, Ansbach,  Germany; Recruiting
      Research Site, Apolda,  Germany; Recruiting
      Research Site, Bad Bramstedt,  Germany; Recruiting
      Research Site, Bad Frankenhausen,  Germany; Recruiting
      Research Site, Bad Salzuflen,  Germany; Recruiting
      Research Site, Bad Schwartau,  Germany; Recruiting
      Research Site, Baden-Baden,  Germany; Recruiting
      Research Site, Bergkamen,  Germany; Recruiting
      Research Site, Bergrheinfeld,  Germany; Recruiting
      Research Site, Berlin,  Germany; Recruiting
      Research Site, Bielefeld,  Germany; Recruiting
      Research Site, Bietigheim-Bissingen,  Germany; Recruiting
      Research Site, Blankenhain,  Germany; Recruiting
      Research Site, Bochum,  Germany; Recruiting
      Research Site, Bonn,  Germany; Recruiting
      Research Site, Burgwedel,  Germany; Recruiting
      Research Site, Dahn,  Germany; Recruiting
      Research Site, Deggendorf,  Germany; Recruiting
      Research Site, Deggingen,  Germany; Recruiting
      Research Site, Dresden,  Germany; Recruiting
      Research Site, Duisburg,  Germany; Recruiting
      Research Site, Düsseldorf,  Germany; Recruiting
      Research Site, Engstingen,  Germany; Recruiting
      Research Site, Erfurt,  Germany; Recruiting
      Research Site, Erlangen,  Germany; Recruiting
      Research Site, Essen,  Germany; Recruiting
      Research Site, Ettlingen,  Germany; Recruiting
      Research Site, Falkensee,  Germany; Recruiting
      Research Site, Freudenberg,  Germany; Recruiting
      Research Site, Fürstenwalde/Spree,  Germany; Recruiting
      Research Site, Garching,  Germany; Recruiting
      Research Site, Gärtringen,  Germany; Recruiting
      Research Site, Gefell,  Germany; Recruiting
      Research Site, Gera,  Germany; Recruiting
      Research Site, Gladbeck,  Germany; Recruiting
      Research Site, Goch,  Germany; Recruiting
      Research Site, Görlitz,  Germany; Recruiting
      Research Site, Greven,  Germany; Recruiting
      Research Site, Hamm,  Germany; Recruiting
      Research Site, Hammelburg,  Germany; Recruiting
      Research Site, Heidelberg,  Germany; Recruiting
      Research Site, Heilbronn,  Germany; Recruiting
      Research Site, Heiligenstadt,  Germany; Recruiting
      Research Site, Heroldsberg,  Germany; Recruiting
      Research Site, Herrischried,  Germany; Recruiting
      Research Site, Hoyerswerda,  Germany; Recruiting
      Research Site, Ilmenau,  Germany; Recruiting
      Research Site, Isernhagen,  Germany; Recruiting
      Research Site, Kehl,  Germany; Recruiting
      Research Site, Kirchlengern,  Germany; Recruiting
      Research Site, Köln,  Germany; Recruiting
      Research Site, Krefeld,  Germany; Recruiting
      Research Site, Kronach,  Germany; Recruiting
      Research Site, Kurort Oberwiesenthal,  Germany; Recruiting
      Research Site, Landau,  Germany; Recruiting
      Research Site, Leipzig,  Germany; Recruiting
      Research Site, Leverkusen,  Germany; Recruiting
      Research Site, Löbau,  Germany; Recruiting
      Research Site, Lohfelden,  Germany; Recruiting
      Research Site, Löhne,  Germany; Recruiting
      Research Site, Lübbecke,  Germany; Recruiting
      Research Site, Lübeck,  Germany; Recruiting
      Research Site, Magstadt,  Germany; Recruiting
      Research Site, Mülsen,  Germany; Recruiting
      Research Site, Münster,  Germany; Recruiting
      Research Site, Netphen,  Germany; Recruiting
      Research Site, Neuss,  Germany; Recruiting
      Research Site, Oettingen,  Germany; Recruiting
      Research Site, Otterbach,  Germany; Recruiting
      Research Site, Pforzheim,  Germany; Recruiting
      Research Site, Plettenberg,  Germany; Recruiting
      Research Site, Porta Westfalica,  Germany; Recruiting
      Research Site, Rehmsdorf,  Germany; Recruiting
      Research Site, Reinfeld,  Germany; Recruiting
      Research Site, Rheinmünster-Greffern,  Germany; Recruiting
      Research Site, Saarbrücken,  Germany; Recruiting
      Research Site, Schnaittenbach,  Germany; Recruiting
      Research Site, Schwerte,  Germany; Recruiting
      Research Site, Siegen,  Germany; Not yet recruiting
      Research Site, Sittensen,  Germany; Not yet recruiting
      Research Site, Spalt,  Germany; Not yet recruiting
      Research Site, Sprockhövel,  Germany; Not yet recruiting
      Research Site, Stadtroda,  Germany; Not yet recruiting
      Research Site, Steinfurt,  Germany; Not yet recruiting
      Research Site, Stutensee,  Germany; Not yet recruiting
      Research Site, Stuttgart,  Germany; Not yet recruiting
      Research Site, Sulzheim,  Germany; Not yet recruiting
      Research Site, Teisendorf,  Germany; Not yet recruiting
      Research Site, Teltow,  Germany; Not yet recruiting
      Research Site, Teterow,  Germany; Not yet recruiting
      Research Site, Thurnau,  Germany; Not yet recruiting
      Research Site, Töging,  Germany; Not yet recruiting
      Research Site, Tostedt,  Germany; Not yet recruiting
      Research Site, Trostberg,  Germany; Not yet recruiting
      Research Site, Uhingen,  Germany; Not yet recruiting
      Reseach Site, Urspringen,  Germany; Not yet recruiting
      Research Site, Viersen,  Germany; Not yet recruiting
      Research Site, Vilshofen,  Germany; Not yet recruiting
      Research Site, Vohenstrauß,  Germany; Not yet recruiting
      Research Site, Waghäusel,  Germany; Not yet recruiting
      Research Site, Waidhaus,  Germany; Not yet recruiting
      Research Site, Wallerfangen,  Germany; Not yet recruiting
      Research Site, Walsrode,  Germany; Not yet recruiting
      Research Site, Weener,  Germany; Not yet recruiting
      Research Site, Weinheim,  Germany; Not yet recruiting
      Research Site, Weißwasser,  Germany; Not yet recruiting
      Research Site, Wesseling,  Germany; Not yet recruiting
      Research Site, Weyhe,  Germany; Not yet recruiting
      Research Site, Wilnsdorf,  Germany; Not yet recruiting
      Research Site, Wilsdruff,  Germany; Not yet recruiting
      Research Site, Worms,  Germany; Not yet recruiting
      Research Site, Wuppertal,  Germany; Not yet recruiting
      Research Site, Zapfendorf,  Germany; Not yet recruiting
      Research Site, Ziltendorf,  Germany; Not yet recruiting
      Research Site, Zwickau,  Germany; Not yet recruiting

Study chairs or principal investigators

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

Study ID Numbers:  D9612L00109; SYMPATHY; EudraCT-No. 2006-001316-76
Last Updated:  September 13, 2006
Record first received:  June 20, 2006
ClinicalTrials.gov Identifier:  NCT00343161
Health Authority: Germany: Federal Institute for Drugs and Medical Devices; Greece: National Organization of Medicines

 

 

 

Gastroesophageal Reflux Disease (GERD)  (Nemours Foundation)

Gastroesophageal Reflux Disease (GERD)  (Cleveland Clinic Foundation)

ClinicalTrials.gov: Gastroesophageal Reflux  (National Institutes of Health)

Heartburn, Hiatal Hernia, and Gastroesophageal Reflux Disease (GERD)  (National Institute of Diabetes and Digestive and Kidney Diseases)

Have You Heard of GERD?  (Nemours Foundation)

Gastroesophageal Reflux in Children and Adolescents  (National Digestive Diseases Information Clearinghouse)

Gastroesophageal Reflux in Infants  (National Digestive Diseases Information Clearinghouse)

Laparoscopic Anti-Reflux Surgery: Surgery for Heartburn  (Society of American Gastrointestinal Endoscopic Surgeons)

Gastroesophageal Reflux Disease (GERD) and Asthma  (Cleveland Clinic Foundation)

Understanding GERD  (American College of Gastroenterology)

Preventing GERD Emergencies  (American College of Emergency Physicians)

Fundoplication Procedure for Children  (Cleveland Clinic Foundation)

What Are the Long-Term Complications of GERD?  (Cleveland Clinic Foundation)

GERD, Barrett's Esophagus and the Risk for Esophageal Cancer  (American Society for Gastrointestinal Endoscopy)

Spitting Up in Babies  (American Academy of Family Physicians)

48-Hour Bravo Esophageal pH Test  (Cleveland Clinic Foundation)

24-Hour Esophageal pH Test  (Cleveland Clinic Foundation)

Non-Cardiac Chest Pain  (Cleveland Clinic Foundation)

Dyspepsia: What It Is and What to Do about It  (American Academy of Family Physicians)

Drugs to Treat Heartburn & Ulcers: The Proton Pump Inhibitors  (Consumers Union of U.S.)

Antacids and Acid Reducers: OTC Relief for Heartburn and Acid Reflux  (American Academy of Family Physicians)

Incredible Journey through the Digestive System  (Food and Drug Administration)

Esophageal Manometry  (Mayo Foundation for Medical Education and Research)

Understanding Esophageal Dilation  (American Society for Gastrointestinal Endoscopy)

Measure Yourself on the "Richter Scale" Acid Test  (American College of Gastroenterology)