Reflux Esophagitis (RE)NCT01536080
Analysis of GERD Symptoms Using Gastroesophageal Reflux Impact Score Questionnaire for Quality of Life
An observational study of Reflux Esophagitis (RE) and Non-erosive Reflux Disease (NERD), run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Even the patients complain GERD symptoms such as heartburn and acid regurgitation the final diagnosis could be reflux esophagitis (RE), non-erosive reflux disease (NERD) and even functional heartburn (FH). In addition, the GERD symptoms are consisted of esophageal symptoms and extraesophageal symptoms. Read more about this study
- Who is it for?
- Ages 16 to 85 years
- Conditions the study is for
- Reflux Esophagitis (RE), Non-erosive Reflux Disease (NERD), Functional Heartburn (FH)
- How many people
- 207 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2008to not given
- 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 16 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Even the patients complain GERD symptoms such as heartburn and acid regurgitation the final diagnosis could be reflux esophagitis (RE), non-erosive reflux disease (NERD) and even functional heartburn (FH).
Who may be able to join
- Adult Subjects (From 16 to 85 years old)
- The subjects with GERD symptom who received 8 week PPI therapy
Who cannot join
- Patients with a history of gastrointestinal surgery, Barrett's esophagus, esophageal motility disorder, duodenal ulcer, benign gastric ulcer or gastroduodenal cancer and systemic disease requiring chronic medication (except for hypertension and diabetes mellitus)
- Patients who took H2 blocker or a PPI to relieve these symptoms within 4 weeks
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Bundang-gu, Seongnam, Gyeonggi-do, 463-707
About this study
Official title: Comparison of Risk Factors, GERD Symptoms and PPI Responses in the Reflux Esophagitis, Non-erosive Reflux Disease and Functional Heartburn Using GERD Impact Scale Questionnaire
Even the patients complain GERD symptoms such as heartburn and acid regurgitation the final diagnosis could be reflux esophagitis (RE), non-erosive reflux disease (NERD) and even functional heartburn (FH). In addition, the GERD symptoms are consisted of esophageal symptoms and extraesophageal symptoms. Thus it is necessary to use effective tool for the measurement of GERD symptoms and response of proton pump inhibitor in short time. Several questionnaires have been made for the assessment of GERD symptoms in recent years However, their screening tools do not include the impact of symptoms on everyday life and take a long time to complete the questionnaires. The GERD impact scale (GIS) questionnaire has been developed to compensate for this. It is a simple, one-page, questionnaire to communicate to the doctor the frequency of reflux symptoms and their effect on quality of life, recognizing that it might also prompt clinicians to make appropriate treatment for patients' symptoms. However, there was no report regarding comparison of the characteristics and response to PPI in RE, NERD and FH groups using GIS questionnaire so far.
- Medical subject headings
- Esophagitis, Peptic, Non-Erosive Reflux Disease
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 |
|---|---|---|
| Reflux esophagitis (RE) | Not described | |
| Non-erosive reflux disease (NERD) | Not described | |
| Functional heartburn (FH) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The GIS score at baseline
Measured: Before 8 weeks PPI treatment(baseline)
Secondary outcomes (1)
Change of the GIS score from baseline
Measured: After 8 weeks PPI treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2012 (estimated)
- Study startJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reflux Esophagitis (RE)Studies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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-control
- Time perspective
- Retrospective
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nayoung Kim, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01536080
- Sponsor's protocol ID
- D9612L00150
- Status last verified
- Feb 2012
- First submitted
- 13 Feb 2012
- Last updated
- 20 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Risk Factors, GERD Symptoms and PPI Responses in the Reflux Esophagitis, Non-erosive Reflux Disease and Functional Heartburn Using GERD Impact Scale Questionnaire
- ClinicalTrials.gov ID
- NCT01536080
- Acronym / sponsor ID
- D9612L00150
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Jul 2008
- First posted
- 20 Feb 2012 (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.
Even the patients complain GERD symptoms such as heartburn and acid regurgitation the final diagnosis could be reflux esophagitis (RE), non-erosive reflux disease (NERD) and even functional heartburn (FH). In addition, the GERD symptoms are consisted of esophageal symptoms and extraesophageal symptoms. Thus it is necessary to use effective tool for the measurement of GERD symptoms and response of proton pump inhibitor in short time. Several questionnaires have been made for the assessment of GERD symptoms in recent years However, their screening tools do not include the impact of symptoms on everyday life and take a long time to complete the questionnaires. The GERD impact scale (GIS) questionnaire has been developed to compensate for this. It is a simple, one-page, questionnaire to communicate to the doctor the frequency of reflux symptoms and their effect on quality of life, recognizing that it might also prompt clinicians to make appropriate treatment for patients' symptoms. However, there was no report regarding comparison of the characteristics and response to PPI in RE, NERD and FH groups using GIS questionnaire so far.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reflux esophagitis (RE) | – | – |
| Non-erosive reflux disease (NERD) | – | – |
| Functional heartburn (FH) | – | – |
Who may qualify
- Ages
- 16 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Even the patients complain GERD symptoms such as heartburn and acid regurgitation the final diagnosis could be reflux esophagitis (RE), non-erosive reflux disease (NERD) and even functional heartburn (FH).
Key inclusion criteria (2 listed)
- Adult Subjects (From 16 to 85 years old)
- The subjects with GERD symptom who received 8 week PPI therapy
Key exclusion criteria (2 listed)
- Patients with a history of gastrointestinal surgery, Barrett's esophagus, esophageal motility disorder, duodenal ulcer, benign gastric ulcer or gastroduodenal cancer and systemic disease requiring chronic medication (except for hypertension and diabetes mellitus)
- Patients who took H2 blocker or a PPI to relieve these symptoms within 4 weeks
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 GIS score at baseline
Time frame: Before 8 weeks PPI treatment(baseline)
1 secondary outcome
Change of the GIS score from baseline
Time frame: After 8 weeks PPI treatment
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 20 Feb 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reflux Esophagitis (RE) and Non-erosive Reflux Disease (NERD), run by Seoul National University Bundang Hospital at 1 site 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 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 20 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 GIS score at baseline (time frame: Before 8 weeks PPI treatment(baseline)). 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 20 Feb 2012.