The Aim of This Study is to Investigate the Frequency and Related Risk Factors of Recurrence, and Quality of Life in Patients With GERD After Treatment With PPIRefreshNCT01378338
Recurrence Rate, Risk Factors for the Recurrence, and Quality of Life in Patients With GERD in Korea-an Observational
An observational study of The Aim of This Study is to Investigate the Frequency and Related Risk Factors of Recurrence, and Quality of Life in Patients With GERD After Treatment With PPI, run by AstraZeneca at 10 sites in South Korea.
Trial summary
Recurrence rate, risk factors for the recurrence, and quality of life in patients with GERD in Korea-an observational study. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- The Aim of This Study is to Investigate the Frequency and Related Risk Factors of Recurrence, and Quality of Life in Patients With GERD After Treatment With PPI
- How many people
- 855 participants
- Where
- 10 sitesSouth Korea
- Study dates
- Jun 2012to Sep 2013
- 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: Patients with typical reflux symptoms (heartburn or regurgitation) undergone upper endoscopy
Who may be able to join
- Both ERD or NERD patient who confirmed by EGD findings within 12 months prior to V1 and have a symptom with moderate or more, at least once per week within 1 week prior to V1 and Patients between age 20 and 80with typical reflux symptoms
- Among the patient who have not taken PPI or H2 blocker within 4 weeks prior to V1, needs to be prescribed PPIs 4~8 weeks as a part of the routine clinical practice due to typical symptom
- Patients who give the signed informed consent
Who cannot join
- Patients with past history of gastrointestinal surgery
- Patients with known malignancy or history of such diseases
- Patients with moderate to severe general medical conditions like ischemic heart disease, chronic renal failure, congestive heart failure, COPD, liver cirrhosis, acute or chronic pancreatitis, or other medical conditions which the investigator considers
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
Research Site
Busan
Research Site
Daegu
Research Site
Daejeon
Research Site
Gangneung
Research Site
Goyang-si
Research Site
Gwangju
Research Site
Incheon
Research Site
Jeonju
Research Site
Seongnam-si
Research Site
Seoul
About this study
Official title: Recurrence Rate, Risk Factors for the Recurrence, and Quality of Life in Patients With GERD in Korea-an Observational Study
Recurrence rate, risk factors for the recurrence, and quality of life in patients with GERD in Korea-an observational study.
- Keywords
- GERD, Comparison between ERD and NERD, Rate of complete resolution, rate of recurrence, QOL, To investigate the frequency and related risk factors of recurrence, and quality of life in patients with GERD after treatment with PPI, The aim of this study is to investigate the frequency and related risk factors of recurrence, and quality of life in patients with GERD after treatment with PPI
- 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 |
|---|---|---|
| Typical reflux symptom by EGD | Total 2000 subjects who has Typical reflux symptom by EGD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of recurrence after treatment with PPI in patients with GERD
Measured: 12month
Response rate to the treatment with PPI in patients with GERD
Measured: 12month
Secondary outcomes (4)
Baseline characteristics related to the recurrence of GERD
Measured: 12month
Rate of complete resolution in each group of patients with ERD or NERD
Measured: 12month
Rate of recurrence in each group of patients with ERD or NERD
Measured: 12month
Quality of life measured by EQ-5D and WPAI-GERD in each group of patients with ERD or NERD
Measured: 12month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2011 (estimated)
- Study startJun 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Aim of This Study is to Investigate the Frequency and Related Risk Factors of Recurrence, and Quality of Life in Patients With GERD After Treatment With PPIStudies 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
- 855 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- HyeWon Koo, Study director, AstraZeneca Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378338
- Sponsor's protocol ID
- NIS-GKR-ATC-2011/1
- Acronym
- Refresh
- Status last verified
- Sep 2013
- First submitted
- 24 May 2011
- Last updated
- 1 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrence Rate, Risk Factors for the Recurrence, and Quality of Life in Patients With GERD in Korea-an Observational Study
- ClinicalTrials.gov ID
- NCT01378338
- Acronym / sponsor ID
- Refresh / NIS-GKR-ATC-2011/1
- Keywords
- GERD, Comparison between ERD and NERD, Rate of complete resolution, rate of recurrence, QOL, To investigate the frequency and related risk factors of recurrence, and quality of life in patients with GERD after treatment with PPI, The aim of this study is to investigate the frequency and related risk factors of recurrence, and quality of life in patients with GERD after treatment with PPI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 855 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 22 Jun 2011 (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.
Recurrence rate, risk factors for the recurrence, and quality of life in patients with GERD in Korea-an observational study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Typical reflux symptom by EGD | – | –Total 2000 subjects who has Typical reflux symptom by EGD |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with typical reflux symptoms (heartburn or regurgitation) undergone upper endoscopy
Key inclusion criteria (3 listed)
- Both ERD or NERD patient who confirmed by EGD findings within 12 months prior to V1 and have a symptom with moderate or more, at least once per week within 1 week prior to V1 and Patients between age 20 and 80with typical reflux symptoms
- Among the patient who have not taken PPI or H2 blocker within 4 weeks prior to V1, needs to be prescribed PPIs 4~8 weeks as a part of the routine clinical practice due to typical symptom
- Patients who give the signed informed consent
Key exclusion criteria (3 listed)
- Patients with past history of gastrointestinal surgery
- Patients with known malignancy or history of such diseases
- Patients with moderate to severe general medical conditions like ischemic heart disease, chronic renal failure, congestive heart failure, COPD, liver cirrhosis, acute or chronic pancreatitis, or other medical conditions which the investigator considers
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
Rate of recurrence after treatment with PPI in patients with GERD
Time frame: 12month
Response rate to the treatment with PPI in patients with GERD
Time frame: 12month
4 secondary outcomes
Baseline characteristics related to the recurrence of GERD
Time frame: 12month
Rate of complete resolution in each group of patients with ERD or NERD
Time frame: 12month
Rate of recurrence in each group of patients with ERD or NERD
Time frame: 12month
Quality of life measured by EQ-5D and WPAI-GERD in each group of patients with ERD or NERD
Time frame: 12month
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 1 Oct 2013.
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.
HyeWon Koo study director
AstraZeneca Korea
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of The Aim of This Study is to Investigate the Frequency and Related Risk Factors of Recurrence, and Quality of Life in Patients With GERD After Treatment With PPI, run by AstraZeneca at 10 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 3 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 1 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
Rate of recurrence after treatment with PPI in patients with GERD (time frame: 12month). The study lists 2 primary outcomes in all. 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 1 Oct 2013.