Gastroesophageal Reflux DiseaseGERDQ-XSNCT01215305
A Cross-sectional Study on the Prevalence and Extraesophageal Symptoms of Gastroesophageal Reflux Disease(GERD) in Patients With Upper GI Symptoms, Visiting the Outpatient Departments of Peripheral Hospitals in Greece
An observational study of Gastroesophageal Reflux Disease, run by AstraZeneca at 19 sites in Greece.
Trial summary
The present study has been designed to provide current data on GERD prevalence in several regional areas of Greece outside the two major urban centres (Athens and Thessaloniki), to measure the treatment response in GERD patients, and to assess the correlations between the two methods of diagnosing GERD, i.e. 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
- 600 participants
- Where
- 19 sitesGreece
- Study dates
- Oct 2010to Mar 2011
- 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 with upper GI symptoms
Who may be able to join
- Provision of written informed consent
- Patients aged 18 and over
- Patients with upper-GI symptoms during the last week prior to the study visit
Who cannot join
- History of oesophageal, gastric or duodenal surgery
- Patients with history of malignancy
- Treatment with acetylsalicylic acid/NSAID during the last week prior to the study visit
- Therapy with PPI for the healing of ulcer induced by treatment with acetylsalicylic acid/NSAID
- Therapy with PPI for HP eradication or for healing of HP-related peptic ulcer
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Greece19 sites
Research Site
Áno Sýros, Kyklades
Research Site
Chalkidiki, Makedonia
Research Site
Chania, Crete
Research Site
Edessa, Makedonia
Research Site
Ioannina, Ipiros
Research Site
Kalamata, Peloponisos
Research Site
Kalávryta, Peloponisos
Research Site
Karditsa, Thesalia
Research Site
Kavala, Makedonia
Research Site
Komotini, Thraki
Research Site
Larissa, Thesalia
Research Site
Limnos, NE Aegian
Research Site
Moláoi, Peloponisos
Research Site
Preveza, Ipiros
Research Site
Rhodes, Dodekanis
Research Site
Serres, Makedonia
Research Site
Sparti, Peloponisos
Research Site
Trikala, Thesalia
Research Site
Volos, Thesalia
About this study
Official title: A Cross-sectional Study on the Prevalence and Extraesophageal Symptoms of GERD in Patients With Upper GI Symptoms, Visiting the Outpatient Departments of Peripheral Hospitals in Greece. The 'GERDQ-XS' Study
The present study has been designed to provide current data on GERD prevalence in several regional areas of Greece outside the two major urban centres (Athens and Thessaloniki), to measure the treatment response in GERD patients, and to assess the correlations between the two methods of diagnosing GERD, i.e. reporting of symptoms by the patient to the physician and completion of the GerdQ questionnaire by the patient. Additionally, this study aims to provide data on the prevalence of extraesophageal symptoms in GERD patients in Greece. The XQS questionnaire will be applied for the identification of these patients and the assessment of the extraesophageal disease burden (frequency and intensity/severity). Finally, an association between the GerdQ and XQS scores will be attempted.
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- Gastroesophageal Reflux Disease, extraesophageal symptoms
- 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 |
|---|---|---|
| Visiting outpatient departments, if symtoms | patients with upper GI symptoms, visiting the outpatient departments of peripheral hospitals in Greece |
What is being measured
The primary outcome is the main question the study is designed to answer.
GerdQ score
Measured: End of recruitment (estimated timeframe :2.5 months)
Secondary outcomes (12)
Demographic data (age, gender, race, weight, height)
Measured: End of recruitment (estimated timeframe :2.5 months)
Marital status
Measured: End of recruitment (estimated timeframe :2.5 months)
Smoking habits, alcohol consumption
Measured: End of recruitment (estimated timeframe :2.5 months)
Patient's eating habits and implementation of dietary recommendations
Measured: End of recruitment (estimated timeframe :2.5 months)
Place of residence (urban, suburban, rural)
Measured: End of recruitment (estimated timeframe :2.5 months)
Education level
Measured: End of recruitment (estimated timeframe :2.5 months)
Occupation
Measured: End of recruitment (estimated timeframe :2.5 months)
General medical history
Measured: End of recruitment (estimated timeframe :2.5 months)
History of upper gastrointestinal diseases
Measured: End of recruitment (estimated timeframe :2.5 months)
Way of antisecretory treatment administration for GI symptoms the last month prior to study visit (if applicable)
Measured: End of recruitment (estimated timeframe :2.5 months)
Compliance to antisecretory treatment (if applicable)
Measured: End of recruitment (estimated timeframe :2.5 months)
Upper GI symptomatology XQS score
Measured: End of recruitment (estimated timeframe :2.5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionMar 2011
- Study completionMar 2011
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
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Panagiotis Pontikis, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01215305
- Sponsor's protocol ID
- NIS-GGR-DUM-2010/1
- Acronym
- GERDQ-XS
- Status last verified
- Apr 2011
- First submitted
- 5 Oct 2010
- Last updated
- 6 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Study on the Prevalence and Extraesophageal Symptoms of GERD in Patients With Upper GI Symptoms, Visiting the Outpatient Departments of Peripheral Hospitals in Greece. The 'GERDQ-XS' Study
- ClinicalTrials.gov ID
- NCT01215305
- Acronym / sponsor ID
- GERDQ-XS / NIS-GGR-DUM-2010/1
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- Gastroesophageal Reflux Disease, extraesophageal symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 6 Oct 2010 (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 present study has been designed to provide current data on GERD prevalence in several regional areas of Greece outside the two major urban centres (Athens and Thessaloniki), to measure the treatment response in GERD patients, and to assess the correlations between the two methods of diagnosing GERD, i.e. reporting of symptoms by the patient to the physician and completion of the GerdQ questionnaire by the patient. Additionally, this study aims to provide data on the prevalence of extraesophageal symptoms in GERD patients in Greece. The XQS questionnaire will be applied for the identification of these patients and the assessment of the extraesophageal disease burden (frequency and intensity/severity). Finally, an association between the GerdQ and XQS scores will be attempted.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Visiting outpatient departments, if symtoms | – | –patients with upper GI symptoms, visiting the outpatient departments of peripheral hospitals in Greece |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with upper GI symptoms
Key inclusion criteria (3 listed)
- Provision of written informed consent
- Patients aged 18 and over
- Patients with upper-GI symptoms during the last week prior to the study visit
Key exclusion criteria (5 listed)
- History of oesophageal, gastric or duodenal surgery
- Patients with history of malignancy
- Treatment with acetylsalicylic acid/NSAID during the last week prior to the study visit
- Therapy with PPI for the healing of ulcer induced by treatment with acetylsalicylic acid/NSAID
- Therapy with PPI for HP eradication or for healing of HP-related peptic ulcer
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
GerdQ score
Time frame: End of recruitment (estimated timeframe :2.5 months)
12 secondary outcomes
Demographic data (age, gender, race, weight, height)
Time frame: End of recruitment (estimated timeframe :2.5 months)
Marital status
Time frame: End of recruitment (estimated timeframe :2.5 months)
Smoking habits, alcohol consumption
Time frame: End of recruitment (estimated timeframe :2.5 months)
Patient's eating habits and implementation of dietary recommendations
Time frame: End of recruitment (estimated timeframe :2.5 months)
Place of residence (urban, suburban, rural)
Time frame: End of recruitment (estimated timeframe :2.5 months)
Education level
Time frame: End of recruitment (estimated timeframe :2.5 months)
Occupation
Time frame: End of recruitment (estimated timeframe :2.5 months)
General medical history
Time frame: End of recruitment (estimated timeframe :2.5 months)
History of upper gastrointestinal diseases
Time frame: End of recruitment (estimated timeframe :2.5 months)
Way of antisecretory treatment administration for GI symptoms the last month prior to study visit (if applicable)
Time frame: End of recruitment (estimated timeframe :2.5 months)
Compliance to antisecretory treatment (if applicable)
Time frame: End of recruitment (estimated timeframe :2.5 months)
Upper GI symptomatology XQS score
Time frame: End of recruitment (estimated timeframe :2.5 months)
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 6 Apr 2011.
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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.
Panagiotis Pontikis study director
AstraZeneca
19 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 19 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 3 inclusion and 5 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 6 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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?
GerdQ score (time frame: End of recruitment (estimated timeframe :2.5 months)). 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 6 Apr 2011.