Symptom Adapted Therapy in GERD Patients
NCT00343161 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 441
Last updated 2011-01-24
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.
Conditions
- Gastroesophageal Reflux Disease
Interventions
- DRUG
-
esomeprazole
- DRUG
-
Gelusil-Lac (Aluminum hydroxide gel,magnesium trisilicate)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Michael Höcker, MD · AstraZeneca Germany
-
Joachim Labenz, MD · Evan. Jung-Stilling-Krankenhaus, Siegen, Germany
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-08-31
- Primary Completion
- 2007-08-31
- Completion
- 2007-08-31
Countries
- Germany
Study Locations
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