Study identifier:D9612L00109
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
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
Gastroesophageal Reflux Disease (GERD).
Phase 4
No
esomeprazole, Gelusil-Lac (Aluminum hydroxide gel,magnesium trisilicate)
All
441
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
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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.
Location
Location
Aiterhofen, Germany
Location
Ansbach, Germany
Location
Apolda, Germany
Location
Bad Bramstedt, Germany
Location
Bad Frankenhausen, Germany
Location
Bad Salzuflen, Germany
Location
Bad Schwartau, Germany
Location
Baden-Baden, Germany
Arms | Assigned Interventions |
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