Clinical trial NCT00343161: Symptom Adapted Therapy in GERD Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastroesophageal Reflux Disease
Keywords: Nexium
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-06-22
Enrollment: 441
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: To compare the efficacy of three different long-term treatment strategies in primary care setting
measure: To compare treatments separately within different levels of symptom load according to clinical judgement at baseline
measure: Number of 'treatment failures' used as primary outcome variable.
Secondary outcomes:
measure: To evaluate whether the Reflux Disease Questionnaire (RDQ)used in primary care setting adds value to clinical judgement in assessing baseline symptom load
measure: Evaluate whether the RDQ facilitates the decision on appropriate acute and maintenance treatment strategy
measure: To assess the additional impact of a concomitant low dose acetylsalicylic acid (ASA) therapy during acute and maintenance phase with regard to efficacy
measure: To evaluate whether there is a difference between treatment strategies with regard to patient satisfaction during maintenance phase using the GERD Impact Scale
Other outcomes:
Locations:
city: Aiterhofen
country: Germany
facility: Research Site
city: Ansbach
country: Germany
facility: Research Site
city: Apolda
country: Germany
facility: Research Site
city: Bad Bramstedt
country: Germany
facility: Research Site
city: Bad Frankenhausen
country: Germany
facility: Research Site
city: Bad Salzuflen
country: Germany
facility: Research Site
city: Bad Schwartau
country: Germany
facility: Research Site
city: Baden-Baden
country: Germany
facility: Research Site
city: Bergkamen
country: Germany
facility: Research Site
city: Bergrheinfeld
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bielefeld
country: Germany
facility: Research Site
city: Bietigheim-Bissingen
country: Germany
facility: Research Site
city: Blankenhain
country: Germany
facility: Research Site
city: Bochum
country: Germany
facility: Research Site
city: Bonn
country: Germany
facility: Research Site
city: Burgwedel
country: Germany
facility: Research Site
city: Dahn
country: Germany
facility: Research Site
city: Deggendorf
country: Germany
facility: Research Site
city: Deggingen
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Duisburg
country: Germany
facility: Research Site
city: Düsseldorf
country: Germany
facility: Research Site
city: Engstingen
country: Germany
facility: Research Site
city: Erfurt
country: Germany
facility: Research Site
city: Erlangen
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Ettlingen
country: Germany
facility: Research Site
city: Falkensee
country: Germany
facility: Research Site
city: Freudenberg
country: Germany
facility: Research Site
city: Fürstenwalde/Spree
country: Germany
facility: Research Site
city: Garching
country: Germany
facility: Research Site
city: Gefell
country: Germany
facility: Research Site
city: Gera
country: Germany
facility: Research Site
city: Gladbeck
country: Germany
facility: Research Site
city: Goch
country: Germany
facility: Research Site
city: Greven
country: Germany
facility: Research Site
city: Gärtringen
country: Germany
facility: Research Site
city: Görlitz
country: Germany
facility: Research Site
city: Hammelburg
country: Germany
facility: Research Site
city: Hamm
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Heilbronn
country: Germany
facility: Research Site
city: Heiligenstadt
country: Germany
facility: Research Site
city: Heroldsberg
country: Germany
facility: Research Site
city: Herrischried
country: Germany
facility: Research Site
city: Hoyerswerda
country: Germany
facility: Research Site
city: Ilmenau
country: Germany
facility: Research Site
city: Isernhagen
country: Germany
facility: Research Site
city: Kehl
country: Germany
facility: Research Site
city: Kirchlengern
country: Germany
facility: Research Site
city: Krefeld
country: Germany
facility: Research Site
city: Kronach
country: Germany
facility: Research Site
city: Kurort Oberwiesenthal
country: Germany
facility: Research Site
city: Köln
country: Germany
facility: Research Site
city: Landau
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Leverkusen
country: Germany
facility: Research Site
city: Lohfelden
country: Germany
facility: Research Site
city: Löbau
country: Germany
facility: Research Site
city: Löhne
country: Germany
facility: Research Site
city: Lübbecke
country: Germany
facility: Research Site
city: Lübeck
country: Germany
facility: Research Site
city: Magstadt
country: Germany
facility: Research Site
city: Mülsen
country: Germany
facility: Research Site
city: Münster
country: Germany
facility: Research Site
city: Netphen
country: Germany
facility: Research Site
city: Neuss
country: Germany
facility: Research Site
city: Oettingen
country: Germany
facility: Research Site
city: Otterbach
country: Germany
facility: Research Site
city: Pforzheim
country: Germany
facility: Research Site
city: Plettenberg
country: Germany
facility: Research Site
city: Porta Westfalica
country: Germany
facility: Research Site
city: Rehmsdorf
country: Germany
facility: Research Site
city: Reinfeld
country: Germany
facility: Research Site
city: Rheinmünster-Greffern
country: Germany
facility: Research Site
city: Saarbrücken
country: Germany
facility: Research Site
city: Schnaittenbach
country: Germany
facility: Research Site
city: Schwerte
country: Germany
facility: Research Site
city: Siegen
country: Germany
facility: Research Site
city: Spalt
country: Germany
facility: Research Site
city: Stutensee
country: Germany
facility: Research Site
city: Sulzheim
country: Germany
facility: Research Site
city: Teterow
country: Germany
facility: Research Site
city: Thurnau
country: Germany
facility: Research Site
city: Uhingen
country: Germany
facility: Research Site
city: Urspringen
country: Germany
facility: Reseach Site
city: Viersen
country: Germany
facility: Research Site
city: Vilshofen
country: Germany
facility: Research Site
city: Waghäusel
country: Germany
facility: Research Site
city: Walsrode
country: Germany
facility: Research Site
city: Weinheim
country: Germany
facility: Research Site
city: Weißwasser
country: Germany
facility: Research Site
city: Wesseling
country: Germany
facility: Research Site
city: Wuppertal
country: Germany
facility: Research Site
city: Zwickau
country: Germany
facility: Research Site
Study officials:
affiliation: AstraZeneca Germany
name: Michael Höcker, MD
role: STUDY_DIRECTOR
affiliation: Evan. Jung-Stilling-Krankenhaus, Siegen, Germany
name: Joachim Labenz, MD
role: PRINCIPAL_INVESTIGATOR
References: