Gastroesophageal Reflux DiseaseGerdQ-GreeceNCT00914342
Prevalence and Impact in Work Productivity of Gastroesophageal Reflux Disease (GERD) in Primary Care Patients With Upper Gastrointestinal (GI) Symptoms Using GerdQ
An observational study of Gastroesophageal Reflux Disease, run by AstraZeneca at 54 sites in Greece.
Trial summary
The purpose of the study is to provide data on the GERD prevalence as percentage of patients with upper GI symptoms that are identified with GERD using the GerdQ Questionnaire. Furthermore the study aims to estimate GERD prevalence in patients based on their symptoms as they respond to a physician's questionnaire, to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease
- How many people
- 889 participants
- Where
- 54 sitesGreece
- Study dates
- Jul 2009to Dec 2009
- 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: Patients who consult their primary care physician and have experienced upper-GI symptoms during the last week prior their consultation
Who may be able to join
- Patients with upper-GI symptoms the last week prior visiting the investigator
Who cannot join
- History of oesophageal, gastric or duodenal surgery
- Treatment with NSAIDs/Acetylsalicylic acid within the last week prior to the study visit
- PPI use for healing of NSAIDs induced ulcer or for HP eradication
Trial locations and contacts
54 sites in 1 country.
54 sites in 1 country
Greece54 sites
Research Site
Acharnes, Attica
Research Site
Ag.Eleutherios, Attica
Research Site
Ag.Paraskeui, Attica
Research Site
Aleksandroupoli, Aleksandroupoli
Research Site
Artémida, Attica
Research Site
Athens, Attica
Research Site
Chalandri, Attica
Research Site
Chalcis, Chalkida
Research Site
Chalkidiki, Chalkidiki
Research Site
Chania, Chania
Research Site
Chrisoupoli, Kavala
Research Site
Corinth, Corinth
Research Site
Drama, Drama
Research Site
Galatsi, Attica
Research Site
Giannitsá, Pella
Research Site
Glifada, Attica
Research Site
Grinion, Aitoloakarnania
Research Site
Heraklion, Herakleion
Research Site
Ilipoli, Attica
Research Site
Ioannina, Ioannina
Research Site
Kalamata, Mesinia
Research Site
Kallithea, Attica
Research Site
Karditsa, Karditsa
Research Site
Kastoria, Kastoria
Research Site
Katerini, Katerini
Research Site
Keratea, Attica
Research Site
Komotini, Komotini
Research Site
Lakonia, Lakonia
Research Site
Lamia, Ftiotida
Research Site
Larrisa, Larrisa
Research Site
Lexena, Ilias
Research Site
Marousi, Attica
Research Site
Mesologgion, Aitoloakarnaniaia
Research Site
Mykonos, Cyclades
Research Site
N Makri, Attica
Research Site
N Smirni, Attica
Research Site
N.Herakeleios, Attica
Research Site
Naupaktos, Aitoloakarnaniaia
Research Site
Pátrai, Achaias
Research Site
Pereus, Pereus
Research Site
Peristeri, Attica
Research Site
Pikermi, Attica
Research Site
Pikerni, Attica
Research Site
Ptolemaida, Ptolemaida
Research Site
Santorini, Cyclades
Research Site
Serres, Serres
Research Site
Spata, Attica
Research Site
Thessaloniki, Salonika
Research Site
Trikala, Trikala
Research Site
Tripoli, Arkadias
Research Site
Véroia, Imathias
Research Site
Volos, Magnisia
Research Site
Xánthi, Xanthi
Research Site
Zakynthos, Eptanisa
About this study
Official title: A Cross-sectional Study on the Prevalence and Impact in Work Productivity of GERD in Primary Care Patients With Upper GI Symptoms Using the Novel Questionnaire GERD-Q. The Greek GERD-Q Study
The purpose of the study is to provide data on the GERD prevalence as percentage of patients with upper GI symptoms that are identified with GERD using the GerdQ Questionnaire. Furthermore the study aims to estimate GERD prevalence in patients based on their symptoms as they respond to a physician's questionnaire, to observe possible variations between the two methods (physicians' symptom rating and GerdQ), to objectively measure treatment response and to identify the percentage of patients that may require alterations of their treatment. Finally, to describe the impact of GERD symptoms on work productivity.
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- Gerd, GerdQ questionnaire, work productivity, Greece
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Upper-GI symptoms in primary-care patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
GERD prevalence as percentage of patients with upper GI symptoms that are identified with GERD using the GerdQ Questionnaire (GerdQ score >=8).
Measured: Single Visit - once
Secondary outcomes (3)
Estimation of GERD prevalence in patients based on their symptoms as they respond to a physician's questionnaire and to observe possible variations between the two methods (physicians' symptom rating and QerdQ)
Measured: Single Visit - Once
Describe the impact of GERD symptoms on work productivity.
Measured: Single Visit - Once
To objectively measure treatment response and to identify the percentage of patients that may require alterations of their treatment.
Measured: Single Visit - Once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2009 (estimated)
- Study startJul 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 889 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Theodoros Rokkas, Dr, Principal investigator, Henry Dynan Hospital, Athens, GreecePanagiotis Pontikis, Dr, Study director, AstraZeneca Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914342
- Sponsor's protocol ID
- NIS-GGR-DUM-2009/1
- Acronym
- GerdQ-Greece
- Status last verified
- Dec 2009
- First submitted
- 3 Jun 2009
- Last updated
- 29 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Study on the Prevalence and Impact in Work Productivity of GERD in Primary Care Patients With Upper GI Symptoms Using the Novel Questionnaire GERD-Q. The Greek GERD-Q Study
- ClinicalTrials.gov ID
- NCT00914342
- Acronym / sponsor ID
- GerdQ-Greece / NIS-GGR-DUM-2009/1
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- Gerd, GerdQ questionnaire, work productivity, Greece
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 889 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Study completion
- Dec 2009 (actual)
- First posted
- 5 Jun 2009 (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 purpose of the study is to provide data on the GERD prevalence as percentage of patients with upper GI symptoms that are identified with GERD using the GerdQ Questionnaire. Furthermore the study aims to estimate GERD prevalence in patients based on their symptoms as they respond to a physician's questionnaire, to observe possible variations between the two methods (physicians' symptom rating and GerdQ), to objectively measure treatment response and to identify the percentage of patients that may require alterations of their treatment. Finally, to describe the impact of GERD symptoms on work productivity.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Upper-GI symptoms in primary-care patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who consult their primary care physician and have experienced upper-GI symptoms during the last week prior their consultation
Key inclusion criteria (1 listed)
- Patients with upper-GI symptoms the last week prior visiting the investigator
Key exclusion criteria (3 listed)
- History of oesophageal, gastric or duodenal surgery
- Treatment with NSAIDs/Acetylsalicylic acid within the last week prior to the study visit
- PPI use for healing of NSAIDs induced ulcer or for HP eradication
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
GERD prevalence as percentage of patients with upper GI symptoms that are identified with GERD using the GerdQ Questionnaire (GerdQ score >=8).
Time frame: Single Visit - once
3 secondary outcomes
Estimation of GERD prevalence in patients based on their symptoms as they respond to a physician's questionnaire and to observe possible variations between the two methods (physicians' symptom rating and QerdQ)
Time frame: Single Visit - Once
Describe the impact of GERD symptoms on work productivity.
Time frame: Single Visit - Once
To objectively measure treatment response and to identify the percentage of patients that may require alterations of their treatment.
Time frame: Single Visit - Once
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 29 Dec 2009.
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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.
Theodoros Rokkas, Dr principal investigator
Henry Dynan Hospital, Athens, Greece
Panagiotis Pontikis, Dr study director
AstraZeneca Greece
54 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux Disease, run by AstraZeneca at 54 sites in Greece.
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 3 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 29 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in Greece. 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?
GERD prevalence as percentage of patients with upper GI symptoms that are identified with GERD using the GerdQ Questionnaire (GerdQ score >=8). (time frame: Single Visit - once). 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 29 Dec 2009.