Gastroesophageal Reflux DiseaseNCT01020890
Prevalence of Gastroesophageal Reflux Disease in Primary Care Patients With Upper Gastrointestinal Symptoms
An observational study of Gastroesophageal Reflux Disease, run by AstraZeneca at 12 sites in Bulgaria.
Trial summary
The purpose of this study is to provide data on the gastroesophageal reflux disease (GERD) prevalence as percentage of patients with upper gastrointestinal (GI) symptoms that are identified with GERD using the Gerd-Q Questionnaire. 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
- 2,210 participants
- Where
- 12 sitesBulgaria
- Study dates
- Nov 2009to Apr 2010
- 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 care clinic
Who may be able to join
- Patients with upper gastrointestinal symptoms
Who cannot join
- History of oesophageal, gastric or duodenal surgery
- Current treatment with antiinflammatory drugs, including OTC
- Current treatment with proton pump inhibitors ang H2-blockers
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Bulgaria12 sites
Research Site
Blagoevgrad
Research Site
Burgas
Research Site
Dobrich
Research Site
Pleven
Research Site
Plovdiv
Research Site
Rousse
Research Site
Sofia
Research Site
Stara Zagora
Research Site
Varna
Research Site
Veliko Tarnovo
Research Site
Vratsa
Research Site
Yambol
About this study
Official title: A Cross-sectional Study on the Prevalence of GERD in Primary Care Patients With Upper GI Symptoms Using the GERD-Q. The Bulgarian GERD-Q Study
The purpose of this study is to provide data on the gastroesophageal reflux disease (GERD) prevalence as percentage of patients with upper gastrointestinal (GI) symptoms that are identified with GERD using the Gerd-Q Questionnaire.
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- GERD diagnosis, GERD-Q, GERD patients' characteristics, GERD
- Medical subject headings
- Gastroesophageal Reflux
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionApr 2010
- Study completionApr 2010
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
- Time perspective
- Cross-sectional
- Enrolment
- 2,210 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01020890
- Sponsor's protocol ID
- NIS-GBG-NEX-2009/1
- Status last verified
- Jul 2010
- First submitted
- 25 Nov 2009
- Last updated
- 12 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Study on the Prevalence of GERD in Primary Care Patients With Upper GI Symptoms Using the GERD-Q. The Bulgarian GERD-Q Study
- ClinicalTrials.gov ID
- NCT01020890
- Acronym / sponsor ID
- NIS-GBG-NEX-2009/1
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- GERD diagnosis, GERD-Q, GERD patients' characteristics, GERD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,210 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 26 Nov 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 this study is to provide data on the gastroesophageal reflux disease (GERD) prevalence as percentage of patients with upper gastrointestinal (GI) symptoms that are identified with GERD using the Gerd-Q Questionnaire.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (1 listed)
- Patients with upper gastrointestinal symptoms
Key exclusion criteria (3 listed)
- History of oesophageal, gastric or duodenal surgery
- Current treatment with antiinflammatory drugs, including OTC
- Current treatment with proton pump inhibitors ang H2-blockers
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
Not reported in the source record.
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 12 Jul 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 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 12 sites in Bulgaria.
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 12 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Bulgaria. 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.
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 12 Jul 2010.