Upper GIT SymptomsGerdQNCT00999063
Prevalence of Gastroesophageal Reflux Disease (GERD) in Patients With Upper Gastrointestinal Track (GIT) Symptoms in Thailand
An observational study of Upper GIT Symptoms, run by AstraZeneca at 25 sites in Thailand.
Trial summary
This is a prospective , epidemiological, multi-centre, phase IV study, approximately 5,000 patients who suffer with upper gastrointestinal tract symptoms. Each patient will be assessed for GERD with GerdQ Thai Version. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper GIT Symptoms
- How many people
- 4,108 participants
- Where
- 25 sitesThailand
- Study dates
- Dec 2009to Feb 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: Primary care clinic
Who may be able to join
- Provision of informed consent prior to any study specific procedures
- Female or male aged at least 18 years
- Patient must be having symptoms suggestive of upper gastrointestinal tract symptoms such as heart burn/ regurgitation
Who cannot join
- Involvement in the planning and /or conduct of the study (applies to both AstraZeneca staff and /or staff at study site
- Participation in a clinical study(excluding non-interventional study or registry) during the last 3 months
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Thailand25 sites
Research Site
Bangkok Noi, Bangkok
Research Site
Klong Luang, Changwat Pathum Thani
Research Site
Maerim, Chiang Mai
Research Site
Maung, Changwat Khon Kaen
Research Site
Maung, Changwat Ratchaburi
Research Site
Maung, Changwat Samut Sakhon
Research Site
Maung, Changwat Sukhothai
Research Site
Maung, Changwat Trang
Research Site
Maung, Chiang Mai
Research Site
Maung, Nakhon Sri Thammarat
Research Site
Maung, Nakhonratchasima
Research Site
Maung, Nakhonsawan
Research Site
Maung, Nakornpathom
Research Site
Maung, Phetchabun
Research Site
Maung, Phuket
Research Site
Maung, Roiet
Research Site
Maung, Ubonratchathani
Research Site
Maung, Uttaradit
Research Site
Muang, Bangkok
Research Site
Muang, Changwat Nonthaburi
Research Site
Muang, Changwat Udon Thani
Research Site
Pathumwan, Bangkok
Research Site
Rajthevee, Bangkok
Research Site
Ratchthewi, Bangkok
Research Site
Varin Chamrap, Ubonratchathani
About this study
Official title: Prevalence of GERD in Patients With upperGITsymptoms in Thailand
This is a prospective , epidemiological, multi-centre, phase IV study, approximately 5,000 patients who suffer with upper gastrointestinal tract symptoms. Each patient will be assessed for GERD with GerdQ Thai Version.
- Conditions
- Upper GIT Symptoms
- Keywords
- GerdQ
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of gastroesophageal reflux disease (GERD) in patients presented with upper gastrointestinal tract symptoms
Secondary outcomes (1)
Response to various treatments for patients who have been diagnosed of GERD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2009 (estimated)
- Study startDec 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper GIT SymptomsStudies 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
- Prospective
- Enrolment
- 4,108 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Somchai Leelasukolvong, Dr., Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999063
- Sponsor's protocol ID
- NIS-GTH-NEX-2009/1
- Acronym
- GerdQ
- Status last verified
- Mar 2011
- First submitted
- 20 Oct 2009
- Last updated
- 31 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of GERD in Patients With upperGITsymptoms in Thailand
- ClinicalTrials.gov ID
- NCT00999063
- Acronym / sponsor ID
- GerdQ / NIS-GTH-NEX-2009/1
- Conditions
- Upper GIT Symptoms
- Keywords
- GerdQ
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,108 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 21 Oct 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.
This is a prospective , epidemiological, multi-centre, phase IV study, approximately 5,000 patients who suffer with upper gastrointestinal tract symptoms. Each patient will be assessed for GERD with GerdQ Thai Version.
Study design
- 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 care clinic
Key inclusion criteria (3 listed)
- Provision of informed consent prior to any study specific procedures
- Female or male aged at least 18 years
- Patient must be having symptoms suggestive of upper gastrointestinal tract symptoms such as heart burn/ regurgitation
Key exclusion criteria (2 listed)
- Involvement in the planning and /or conduct of the study (applies to both AstraZeneca staff and /or staff at study site
- Participation in a clinical study(excluding non-interventional study or registry) during the last 3 months
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
Prevalence of gastroesophageal reflux disease (GERD) in patients presented with upper gastrointestinal tract symptoms
1 secondary outcome
Response to various treatments for patients who have been diagnosed of GERD
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 31 Mar 2011.
Related trials for Upper GIT Symptoms
Not yet recruitingObservational study
HALP as a Novel Score for Prediction of Mortality and re_bleeding in Upper GIT Bleeding
Upper Gastrointestinal Bleeding
Not yet recruitingObservational study
Endoscopic Findings in Patients With Upper GIT Bleeding
GIT - Gastrointestinal Tract Hemorrhage
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.
Somchai Leelasukolvong, Dr. principal investigator
Siriraj Hospital
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper GIT Symptoms, run by AstraZeneca at 25 sites in Thailand.
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 2 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 31 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Thailand. 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?
Prevalence of gastroesophageal reflux disease (GERD) in patients presented with upper gastrointestinal tract symptoms. 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 31 Mar 2011.