Gastroesophageal Reflux DiseasePreedomNCT00768196
Prevalence of EED and Quality of Life Evaluated by Gastroesophageal Reflux Disease (GERD)-Q in Korean GERD Patients
An observational study of Gastroesophageal Reflux Disease, run by AstraZeneca at 4 sites in South Korea.
Trial summary
The purpose of this study is to asses the EED symptom prevalence in Koran GERD patients with typical reflux symptom and to evaluate quality of life with the scales including Gerd Q. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- How many people
- 2,000 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Sep 2008to Feb 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: general hospital sample
Who may be able to join
- GERD patients who have experienced heartburn or acid regurgitation during past 7 days
- GERD patients who have already undergone endoscopy before enrolment
Who cannot join
- Involvement in the planning and conduct of the programme
- The person who took the medicine such as PPI or H2RA during the last 7 days
- Severe systemic disease
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Research Site
Cheonan, Chungcheongnam-do
Research Site
Seoul, Kyungkido
Research Site
Sungnam, Kyungkido
Research Site
Suwon, Kyungkido
About this study
The purpose of this study is to asses the EED symptom prevalence in Koran GERD patients with typical reflux symptom and to evaluate quality of life with the scales including Gerd Q.
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- GERD, Korea, typical symptom, quality of life, Naturalistic, epidemiological
- Medical subject headings
- Gastroesophageal Reflux
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary variable is the total rate of GERD patients who had EED symptom and effect on their quality of life.
Secondary outcomes (1)
The secondary variable is the comparison of the EED symptom frequency in ERD and NERD patients.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2008 (estimated)
- Study startSep 2008
- Study completionFeb 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
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Joon-Woo Bahn, Study director, AstraZeneca Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00768196
- Sponsor's protocol ID
- NIS-GKR-DUM-2008/1
- Acronym
- Preedom
- Status last verified
- Dec 2010
- First submitted
- 1 Oct 2008
- Last updated
- 7 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of EED and Quality of Life Evaluated by Gastroesophageal Reflux Disease (GERD)-Q in Korean GERD Patients
- ClinicalTrials.gov ID
- NCT00768196
- Acronym / sponsor ID
- Preedom / NIS-GKR-DUM-2008/1
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- GERD, Korea, typical symptom, quality of life, Naturalistic, epidemiological
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Study completion
- Feb 2009 (actual)
- First posted
- 7 Oct 2008 (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 asses the EED symptom prevalence in Koran GERD patients with typical reflux symptom and to evaluate quality of life with the scales including Gerd Q.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- general hospital sample
Key inclusion criteria (2 listed)
- GERD patients who have experienced heartburn or acid regurgitation during past 7 days
- GERD patients who have already undergone endoscopy before enrolment
Key exclusion criteria (3 listed)
- Involvement in the planning and conduct of the programme
- The person who took the medicine such as PPI or H2RA during the last 7 days
- Severe systemic disease
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
The primary variable is the total rate of GERD patients who had EED symptom and effect on their quality of life.
1 secondary outcome
The secondary variable is the comparison of the EED symptom frequency in ERD and NERD patients.
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 7 Dec 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.
Joon-Woo Bahn study director
AstraZeneca Korea
4 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 4 sites in South Korea.
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 2 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 7 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. 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?
The primary variable is the total rate of GERD patients who had EED symptom and effect on their quality of life.. 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 7 Dec 2010.