- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00545883
Impact of GERD on Daily Life (NIS) (Alegria)
January 25, 2012 updated by: AstraZeneca
An Epidemiological, Observational Study to Describe Symptom Control and Impact on Daily Life of GERD in Patients With Erosive Gastroesophageal Reflux Disease.
The aim of this study is to gather epidemiological data in a population of GERD patients in primary care with a history of erosive esophagitis (less than or equal to 3 years).
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
2001
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aarschot, Belgium
- Research Site
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Aartselaar, Belgium
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Alken, Belgium
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Angleur, Belgium
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Antwerpen, Belgium
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Balen, Belgium
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Berchem, Belgium
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Beringen, Belgium
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Beyne-Heusay, Belgium
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Boechout, Belgium
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Boirs, Belgium
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Boom, Belgium
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Borgerhout, Belgium
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Bornem, Belgium
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Bruxelles, Belgium
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Chenee, Belgium
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Court-Saint-Etienne, Belgium
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Deurne, Belgium
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Diegem, Belgium
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Diest, Belgium
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Dilbeek, Belgium
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Duffel, Belgium
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Eindhout, Belgium
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Ekeren, Belgium
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Essen, Belgium
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Flemalle, Belgium
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Fleron, Belgium
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Geel, Belgium
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Genk, Belgium
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Gooik, Belgium
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Grace-Hollogne, Belgium
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Grand-Rechain, Belgium
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Grivegnee, Belgium
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Grobbendonk, Belgium
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Groot-Biigaarden, Belgium
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Halen, Belgium
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Hannut, Belgium
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Herentals, Belgium
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Herenthout, Belgium
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Hermalle-sous-Huy, Belgium
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Herselt, Belgium
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Herstal, Belgium
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Herve, Belgium
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Heusden-Zolder, Belgium
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Hoboken, Belgium
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Hoeilaart, Belgium
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Houthalen-Helchteren, Belgium
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Huy, Belgium
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Itegem, Belgium
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Ivoz-Ramet, Belgium
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Jodoigne, Belgium
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Keerbergen, Belgium
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Kortrijk-Dutsel, Belgium
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Landen, Belgium
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Lasne, Belgium
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Leefdaal, Belgium
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Leopoldsburg, Belgium
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Liederkerke, Belgium
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Liege, Belgium
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Lier, Belgium
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Lommel, Belgium
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Londerzeel, Belgium
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Louveigne, Belgium
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Maasmechelen, Belgium
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Mechelen, Belgium
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Merksem, Belgium
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Munsterbilzen, Belgium
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Niel, Belgium
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Noordewijk, Belgium
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Olen, Belgium
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Oostmalle, Belgium
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Overpelt, Belgium
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Paal-Beringen, Belgium
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Pellaines, Belgium
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Peutie, Belgium
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Pulle, Belgium
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Putte, Belgium
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Puurs, Belgium
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Reet, Belgium
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Retie, Belgium
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Retinne, Belgium
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Riemst, Belgium
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Rijkhoven, Belgium
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Rixensart, Belgium
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Roosdaal, Belgium
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Schelle, Belgium
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Schilde, Belgium
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Schulen-herk-de-stad, Belgium
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Seraing, Belgium
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Spouwen, Belgium
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Stabroek, Belgium
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Steenokkerzeel, Belgium
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Ternat, Belgium
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Tessenderlo, Belgium
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Tienen, Belgium
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Tollembeek, Belgium
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Tongeren, Belgium
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Vierset-Barse, Belgium
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Viller-le-Temple, Belgium
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Vilvoorde, Belgium
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Walem, Belgium
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Wambeek, Belgium
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Weerde, Belgium
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Wespelaar, Belgium
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Westerlo, Belgium
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Westmeerbeek, Belgium
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Willebroek, Belgium
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Wilrijk, Belgium
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Wolvertem, Belgium
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Zandhoven, Belgium
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Zemst, Belgium
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Zichem, Belgium
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Primary & Specialty care units
Description
Inclusion Criteria:
- Patients with erosive esophagitis (endoscopical findings according to the Los Angeles Classification; grade A-D) currently not treated with a proton pump inhibitor, for whom the general practitioner (GP) has decided to initiate or change the treatment for GERD
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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To gather epidemiological data in a population of GERD patients
Time Frame: After collection of all questionnaires
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After collection of all questionnaires
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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To evaluate the added value of a new patient questionnaire (GERD Impact Scale) as a useful tool for the initial and long-term management of GERD patients: determination of the appropriate treatment and evaluation of the response to treatment.
Time Frame: After collection of all questionnaires
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After collection of all questionnaires
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: E. Louis, PR, ULG
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2006
Study Completion (Actual)
March 1, 2008
Study Registration Dates
First Submitted
October 15, 2007
First Submitted That Met QC Criteria
October 16, 2007
First Posted (Estimate)
October 17, 2007
Study Record Updates
Last Update Posted (Estimate)
January 26, 2012
Last Update Submitted That Met QC Criteria
January 25, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIS-GBE-NEX-2006/1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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