Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| SYMPATHY | |||
| EudraCT-No. 2006-001316-76 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| esomeprazole | Drug | |||
| Gelusil-Lac (Aluminum hydroxide gel,magnesium trisilicate) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Höcker, MD | AstraZeneca Germany | Study Director |
| Joachim Labenz, MD | Evan. Jung-Stilling-Krankenhaus, Siegen, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Aiterhofen | Germany | ||||
| Research Site |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| 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 | Cologne | 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 | 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-Süd | Germany |
| Research Site | Kehl | Germany |
| Research Site | Kirchlengern | Germany |
| Research Site | Krefeld | Germany |
| Research Site | Kronach | Germany |
| Research Site | Landau | Germany |
| Research Site | Leipzig | Germany |
| Research Site | Leverkusen | Germany |
| Research Site | Lohfelden | Germany |
| Research Site | Löbau | 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 | Oberwiesenthal | Germany |
| Research Site | Oettingen in Bayern | 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 | Germany |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided