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NCT00842387 Clinical Trial

Evaluation Study of a Management Strategy for Gastroesophageal Reflux Disease (GERD)

Heartburn Clinical Trial

Official title:
Evaluation Study of a Management Strategy for Gastroesophageal Reflux Disease (GERD)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00842387
Other study ID # NIS-GEU-DUM-2008/1
Secondary ID
Status Completed
Phase N/A
First received February 11, 2009
Last updated December 22, 2009
Start date January 2009
Est. completion date December 2009

Study information
Verified date December 2009
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Austria: Agency for Health and Food SafetyItaly: Ethics CommitteeNorway: Norwegian Medicines AgencyNorway:National Committee for Medical and Health Research EthicsSpain: Ethics CommitteeSweden: Medical Products AgencySweden: Regional Ethical Review Board
Study type Observational

Clinical Trial Summary

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.

Description:

In Norway, it is developed as a clinical trial where a new structured pathway in the diagnosis and treatment of GERD is compared to the ordinary clinical pathway consisting of the endoscopic/pH-metry approach in patients referred from primary care to GI specialists.

In Italy, it is a PCP-level, cluster randomized, controlled trial comparing a structured clinical pathway versus usual care in patients with GERD. The implementation consists of training sessions on the clinical pathway with the selected PCPs (Implementation Group).

In Sweden, it is a cluster-randomised interventional study performed within daily clinical practice for the purpose of assessing the effect of the implementation of the structured clinical pathway in patients identified as having GERD. The participating PCCs will be randomised (1:1) to implement the structured clinical pathway or handling the patients according to local clinical routines.

In Austria and Spain, it is a cluster-randomized study to be developed within daily clinical practice for the purpose of assessing the effect of the implementation of the structured clinical pathway on GERD patients . The evaluation study will take place subsequent to a prior implementation of a clinical pathway. The implementation consists of a detailed explanation by training-materials about the clinical pathway in a selected randomized pool of PCCs. The implementation that will be evaluated is outside of the study procedures; it is the physician's decision whether to apply it or not.

Recruitment information / eligibility
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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
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

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

Austria,  Italy,  Norway,  Spain,  Sweden, 

Outcome
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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