Heartburn Clinical Trial
Official title:
Evaluation Study of a Management Strategy for Gastroesophageal Reflux Disease (GERD)
The aim of this project is to compare the GERD clinical outcomes in patients where a
structured pathway using the GerdQ questionnaire is implemented compared with the clinical
outcomes of those treated without this implementation.
This is a European project with 5 participating countries (Austria, Italy, Norway, Spain and
Sweden). Due to different characteristics regarding the actual management of this disease in
the 5 countries, each country had the flexibility to introduce design differences and
changes in the study protocol.
Status | Completed |
Enrollment | 2370 |
Est. completion date | December 2009 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients presenting with symptoms suggestive of GERD (heartburn or regurgitation as prevailing symptoms) of any severity - Patient able to understand and complete the questionnaires Exclusion Criteria: - Alarm symptoms (Dysphagia/odynophagia, anorexia, anaemia, unintentional weight loss, abdominal mass, upper GI bleeding) - If the patient is participating in any clinical trial, he/she cannot take part on this study - Any condition that, in the investigator's opinion, makes the patient's participation in the study difficult |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Austria | Research Site | Amstetten | |
Austria | Research Site | Baden | |
Austria | Research Site | Bludenz | |
Austria | Research Site | Bregenz | |
Austria | Research Site | Feldbach | |
Austria | Research Site | Gmunden | |
Austria | Research Site | Graz | |
Austria | Research Site | Gross Gerungs | |
Austria | Research Site | Innsbruck | |
Austria | Research Site | Kitzbuhel | |
Austria | Research Site | Klagenfurt | |
Austria | Research Site | Krems | |
Austria | Research Site | Kufstein | |
Austria | Research Site | Leibnitz | |
Austria | Research Site | Leoben | |
Austria | Research Site | Linz | |
Austria | Research Site | Mattersburg | |
Austria | Research Site | Mistelbach | |
Austria | Research Site | Murzzuschlag | |
Austria | Research Site | Neunkirchen | |
Austria | Research Site | Neusiedl | |
Austria | Research Site | Perg | |
Austria | Research Site | Schwaz | |
Austria | Research Site | St. Veit | |
Austria | Research Site | Steyr | |
Austria | Research Site | Villach | |
Austria | Research Site | Vocklabruck | |
Austria | Research Site | Volkermarkt | |
Austria | Research Site | Wels | |
Austria | Research Site | Zell | |
Italy | Research Site | Brescia | |
Norway | Research Site | Aalesund | |
Norway | Research Site | Arendal | |
Norway | Research Site | Bergen | |
Norway | Research Site | Bodo | |
Norway | Research Site | Haugesund | |
Norway | Research Site | Kristiansund | |
Norway | Research Site | Levanger | |
Norway | Research Site | Molde | |
Norway | Research Site | Mosjoen | |
Norway | Research Site | Orkdal | |
Norway | Research Site | Oslo | |
Norway | Research Site | Tynset | |
Spain | Research Site | Valencia | |
Sweden | Research Site | Arlov | |
Sweden | Research Site | Dalby | |
Sweden | Research Site | Falkoping | |
Sweden | Research Site | Farsta | |
Sweden | Research Site | Goteborg | |
Sweden | Research Site | Helsingborg | |
Sweden | Research Site | Karlshamn | |
Sweden | Research Site | Kristianstad | |
Sweden | Research Site | Kungsangen | |
Sweden | Research Site | Lulea | |
Sweden | Research Site | Lund | |
Sweden | Research Site | Malmo | |
Sweden | Research Site | Munkedal | |
Sweden | Research Site | Nordstan(Goteborg) | |
Sweden | Research Site | Partille | |
Sweden | Research Site | Pitea | |
Sweden | Research Site | Skanor | |
Sweden | Research Site | Sodertalje | |
Sweden | Research Site | Solna | |
Sweden | Research Site | Stockholm | |
Sweden | Research Site | Trollhattan | |
Sweden | Research Site | Vannas |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Austria, Italy, Norway, Spain, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Control of symptoms based on results of GerdQ, need of treatment change and % of patients requiring referral to a specialist (Austria and Italy). | up to 8 weeks | No | |
Primary | Treatment response and symptomatic control (Norway) | up to 8 weeks | No | |
Primary | Symptom relief and patient satisfaction with treatment (Spain) | up to 8 weeks | No | |
Primary | Symptom relief measured by RDQ (Sweden) | 5 months +/- 4 weeks | No | |
Secondary | Use and consumption of healthcare resources (all countries). Physicians adherence to the clinical pathway (Austria, Spain) and intrinsic characteristics of the physicians/PCC that may affect this adherence (Austria) | Up to 8 weeks, except for Sweden: 5 months +/- 4 weeks | No | |
Secondary | Percentage of patients referred to specialists (Spain). Health status based on EQ-5D measure (Norway, Sweden). Work productivity based on the WPAI-GERD questionnaire (Norway, Sweden) | Up to 8 weeks, except for Sweden: 5 months +/- 4 weeks | No | |
Secondary | Sweden: Persisting symptoms according to GerdQ, Treatment changes, Reason(s) for the patient consultation at visit 1. To explore other GERD related symptoms, To describe patients' experience of treatment/care given during the study. | 5 months +/- 4 weeks | No |
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