Symptom Adapted Therapy in GERD Patients

Condition(s) targeted: Gastroesophageal Reflux Disease (GERD).

Intervention: esomeprazole (Drug); Gelusil-Lac (Aluminum hydroxide gel,magnesium trisilicate) (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Michael Höcker, MD, Study Director, Affiliation: AstraZeneca Germany
Joachim Labenz, MD, Principal Investigator, Affiliation: Evan. Jung-Stilling-Krankenhaus, Siegen, Germany

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.

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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome:

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:

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

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): 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

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

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Research Site, Blankenhain, Germany

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Starting date: August 2006
Last updated: March 7, 2007