Gastroesophageal Reflux DiseaseNCT00786773
Survey to Describe Impact of Reflux Disease on Everyday Life in GERD Patients Before and After 4 Weeks Treatment.
An observational study of Gastroesophageal Reflux Disease, run by AstraZeneca at 18 sites in Vietnam.
Trial summary
To describe the change of impact of reflux symptoms on the everyday life perceived by patients before and after 4 weeks treatment by using GERD Impact Scale questionnaire (GIS) by total GERD patient population and by treatment group; and to describe the concordance between patient-reported and physician-reported… 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
- 2,091 participants
- Where
- 18 sitesVietnam
- Study dates
- Oct 2008to Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target survey population is existing GERD patients or newly diagnosed GERD patients, who will be treated for GERD with PPI, H2RA, antacid, prokinetics, combination therapy ... at Visit 1 and will come back after 4 weeks for clinical re-assessment (Visit 2)
Who may be able to join
- Patients with GERD diagnosed clinically or by endoscopy and prescribed with medical treatments
- Provision of written informed consent
Who cannot join
- Patients cannot read and/or understand GIS
- Patients with the history or symptoms of peptic ulcer, gastrointestinal cancer, serious or malignant diseases (anorexia, weight loss, anemia, fever …)
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Vietnam18 sites
Research Site
Bien Hoa, Dong Nai
Research Site
Buon Ma Thuot, Dac Lac
Research Site
Ca Mau
Research Site
Can Tho
Research Site
Cao Lanh, Dong Thap
Research Site
Da Nang
Research Site
Haiphong
Research Site
Hanoi
Research Site
Ho Chi Minh City
Research Site
Huế, Thừa Thiên Huế Province
Research Site
Long Xuyen, An Giang
Research Site
Mỹ Tho
Research Site
Nam Định
Research Site
Nha Trang, Khanh Hoa
Research Site
Qui Nhon, Binh Dinh
Research Site
Sa Dec, Dong Thap
Research Site
Thái Bình
Research Site
Thống Nhất, Dong Nai
About this study
Official title: Epidemiological Survey to Describe Impact of Reflux Disease on Everyday Life in GERD Patients Before and After 4 Weeks Treatment
To describe the change of impact of reflux symptoms on the everyday life perceived by patients before and after 4 weeks treatment by using GERD Impact Scale questionnaire (GIS) by total GERD patient population and by treatment group; and to describe the concordance between patient-reported and physician-reported symptom load.
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- GERD, reflux symptom, heartburn, acid regurgitation, PPI, H2RA, antacid
- Medical subject headings
- Gastroesophageal Reflux, Heartburn
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 |
|---|---|---|
| 1 | GERD patients who will be treated for GERD with PPI, H2RA, antacid, prokinetics, combination therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type, frequency and severity of the GERD symptoms
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2008 (estimated)
- Study startOct 2008
- Study completionJun 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
- Time perspective
- Prospective
- Enrolment
- 2,091 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ta Long, Principal investigator, Vietnam Association of GastroenterologyDao Van Long, Principal investigator, Medical University of HanoiTran Kieu Mien, Principal investigator, HCMC Association of GastroenterologyLe Thanh Ly, Principal investigator, Cho Ray Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00786773
- Sponsor's protocol ID
- NIS-GVN-DUM-2008/1
- Status last verified
- Dec 2010
- First submitted
- 5 Nov 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
- Epidemiological Survey to Describe Impact of Reflux Disease on Everyday Life in GERD Patients Before and After 4 Weeks Treatment
- ClinicalTrials.gov ID
- NCT00786773
- Acronym / sponsor ID
- NIS-GVN-DUM-2008/1
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- GERD, reflux symptom, heartburn, acid regurgitation, PPI, H2RA, antacid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,091 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Study completion
- Jun 2009 (actual)
- First posted
- 6 Nov 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.
To describe the change of impact of reflux symptoms on the everyday life perceived by patients before and after 4 weeks treatment by using GERD Impact Scale questionnaire (GIS) by total GERD patient population and by treatment group; and to describe the concordance between patient-reported and physician-reported symptom load.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –GERD patients who will be treated for GERD with PPI, H2RA, antacid, prokinetics, combination therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target survey population is existing GERD patients or newly diagnosed GERD patients, who will be treated for GERD with PPI, H2RA, antacid, prokinetics, combination therapy ... at Visit 1 and will come back after 4 weeks for clinical re-assessment (Visit 2)
Key inclusion criteria (2 listed)
- Patients with GERD diagnosed clinically or by endoscopy and prescribed with medical treatments
- Provision of written informed consent
Key exclusion criteria (2 listed)
- Patients cannot read and/or understand GIS
- Patients with the history or symptoms of peptic ulcer, gastrointestinal cancer, serious or malignant diseases (anorexia, weight loss, anemia, fever …)
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
Type, frequency and severity of the GERD symptoms
Time frame: 4 weeks
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.
Ta Long principal investigator
Vietnam Association of Gastroenterology
Dao Van Long principal investigator
Medical University of Hanoi
Tran Kieu Mien principal investigator
HCMC Association of Gastroenterology
18 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 18 sites in Vietnam.
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 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 18 sites in Vietnam. 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?
Type, frequency and severity of the GERD symptoms (time frame: 4 weeks). 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.