Symptom Adapted Therapy in GERD Patients

Gastroesophageal Reflux Disease Clinical Trial

— SYMPATHY  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00343161
• Other study ID #: D9612L00109
• Secondary ID: SYMPATHYEudraCT-
• Status: Completed
• Phase: Phase 4
• First received: June 20, 2006
• Last updated: January 21, 2011
• Start date: August 2006
• Est. completion date: August 2007

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 441
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• esomeprazole

• Gelusil-Lac (Aluminum hydroxide gel,magnesium trisilicate)

Locations

Country	Name	City	State
Germany	Research Site	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	Gärtringen
Germany	Research Site	Gefell
Germany	Research Site	Gera
Germany	Research Site	Gladbeck
Germany	Research Site	Goch
Germany	Research Site	Görlitz
Germany	Research Site	Greven
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	Köln
Germany	Research Site	Krefeld
Germany	Research Site	Kronach
Germany	Research Site	Kurort Oberwiesenthal
Germany	Research Site	Landau
Germany	Research Site	Leipzig
Germany	Research Site	Leverkusen
Germany	Research Site	Löbau
Germany	Research Site	Lohfelden
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	Reseach Site	Urspringen
Germany	Research 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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the efficacy of three different long-term treatment strategies in primary care setting
Primary	To compare treatments separately within different levels of symptom load according to clinical judgement at baseline
Primary	Number of 'treatment failures' used as primary outcome variable.
Secondary	To evaluate whether the Reflux Disease Questionnaire (RDQ)used in primary care setting adds value to clinical judgement in assessing baseline symptom load
Secondary	Evaluate whether the RDQ facilitates the decision on appropriate acute and maintenance treatment strategy
Secondary	To assess the additional impact of a concomitant low dose acetylsalicylic acid (ASA) therapy during acute and maintenance phase with regard to efficacy
Secondary	To evaluate whether there is a difference between treatment strategies with regard to patient satisfaction during maintenance phase using the GERD Impact Scale