GERDAlegriaNCT00545883
Impact of GERD on Daily Life (NIS)
An observational study of GERD, run by AstraZeneca at 112 sites in Belgium.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GERD
- How many people
- 2,001 participants
- Where
- 112 sitesBelgium
- Study dates
- Jun 2006to Mar 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary \& Specialty care units
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
112 sites in 1 country.
112 sites in 1 country
Belgium112 sites
Research Site
Aarschot
Research Site
Aartselaar
Research Site
Alken
Research Site
Angleur
Research Site
Antwerp
Research Site
Balen
Research Site
Berchem
Research Site
Beringen
Research Site
Beyne-Heusay
Research Site
Boechout
Research Site
Boirs
Research Site
Boom
Research Site
Borgerhout
Research Site
Bornem
Research Site
Brussels
Research Site
Chênée
Research Site
Court-Saint-Étienne
Research Site
Deurne
Research Site
Diegem
Research Site
Diest
Research Site
Dilbeek
Research Site
Duffel
Research Site
Eindhout
Research Site
Ekeren
Research Site
Essen
Research Site
Flémalle
Research Site
Fléron
Research Site
Geel
Research Site
Genk
Research Site
Gooik
Research Site
Grâce-Hollogne
Research Site
Grand-Rechain
Research Site
Grivegnée
Research Site
Grobbendonk
Research Site
Groot-Biigaarden
Research Site
Halen
Research Site
Hannut
Research Site
Herentals
Research Site
Herenthout
Research Site
Hermalle-sous-Huy
Research Site
Herselt
Research Site
Herstal
Research Site
Herve
Research Site
Heusden-Zolder
Research Site
Hoboken
Research Site
Hoeilaart
Research Site
Houthalen-Helchteren
Research Site
Huy
Research Site
Itegem
Research Site
Ivoz-Ramet
Research Site
Jodoigne
Research Site
Keerbergen
Research Site
Kortrijk-Dutsel
Research Site
Landen
Research Site
Lasne
Research Site
Leefdaal
Research Site
Leopoldsburg
Research Site
Liederkerke
Research Site
Liège
Research Site
Lier
Research Site
Lommel
Research Site
Londerzeel
Research Site
Louveigné
Research Site
Maasmechelen
Research Site
Mechelen
Research Site
Merksem
Research Site
Munsterbilzen
Research Site
Niel
Research Site
Noordewijk
Research Site
Olen
Research Site
Oostmalle
Research Site
Overpelt
Research Site
Paal-Beringen
Research Site
Pellaines
Research Site
Peutie
Research Site
Pulle
Research Site
Putte
Research Site
Puurs
Research Site
Reet
Research Site
Retie
Research Site
Retinne
Research Site
Riemst
Research Site
Rijkhoven
Research Site
Rixensart
Research Site
Roosdaal
Research Site
Schelle
Research Site
Schilde
Research Site
Schulen-herk-de-stad
Research Site
Seraing
Research Site
Spouwen
Research Site
Stabroek
Research Site
Steenokkerzeel
Research Site
Ternat
Research Site
Tessenderlo
Research Site
Tienen
Research Site
Tollembeek
Research Site
Tongeren
Research Site
Vierset-Barse
Research Site
Viller-le-Temple
Research Site
Vilvoorde
Research Site
Walem
Research Site
Wambeek
Research Site
Weerde
Research Site
Wespelaar
Research Site
Westerlo
Research Site
Westmeerbeek
Research Site
Willebroek
Research Site
Wilrijk
Research Site
Wolvertem
Research Site
Zandhoven
Research Site
Zemst
Research Site
Zichem
About this study
Official title: 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).
- Conditions
- GERD
- Keywords
- GERD, esophagitis, PPI
- Medical subject headings
- Gastroesophageal Reflux, Esophagitis
What is being measured
The primary outcome is the main question the study is designed to answer.
To gather epidemiological data in a population of GERD patients
Measured: After collection of all questionnaires
Secondary outcomes (1)
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.
Measured: After collection of all questionnaires
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2007 (estimated)
- Study startJun 2006
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,001 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- E. Louis, PR, Principal investigator, ULG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00545883
- Sponsor's protocol ID
- NIS-GBE-NEX-2006/1
- Acronym
- Alegria
- Status last verified
- Jan 2012
- First submitted
- 15 Oct 2007
- Last updated
- 26 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Epidemiological, Observational Study to Describe Symptom Control and Impact on Daily Life of GERD in Patients With Erosive Gastroesophageal Reflux Disease.
- ClinicalTrials.gov ID
- NCT00545883
- Acronym / sponsor ID
- Alegria / NIS-GBE-NEX-2006/1
- Conditions
- GERD
- Keywords
- GERD, esophagitis, PPI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,001 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Study completion
- Mar 2008 (actual)
- First posted
- 17 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary \& Specialty care units
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To gather epidemiological data in a population of GERD patients
Time frame: After collection of all questionnaires
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
E. Louis, PR principal investigator
ULG
112 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GERD, run by AstraZeneca at 112 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 112 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To gather epidemiological data in a population of GERD patients (time frame: After collection of all questionnaires). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2012.