Gastroesophageal Reflux DiseaseNCT03616119
Gastroesophageal Reflux Disease in Azerbaijan
An observational study of Gastroesophageal Reflux Disease, run by Sevda Aghayeva at 1 site in Azerbaijan.
Trial summary
To evaluate the prevalence of Gastroesophageal reflux disease in Azerbaijan. It is intended to evaluate the prevalence of the disease in the regions as well as the capital by cluster sampling ,ethitology and to compare the outcomes depending on the geographical location. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux Disease
- How many people
- 1,000 participants
- Where
- 1 siteAzerbaijan
- Study dates
- 1 Jan 2018to 1 Sep 2019
- How long will I take part?
- 12 Months
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Azerbaijan is divided by clusters with a definite numbers of individuals to take survey on reflux disease in the given age range and calculated by proportion of males and females.
Who may be able to join
- Age: 18-80
- Both genders
- Hearburn
- Belching
- Regurgitation
Who cannot join
- protom pomp inhibitor use
- antibiotic use in the last 4 weeks
- upper GI surgery
Trial locations and contacts
1 site in 1 country.
Azerbaijan1 site
Azerbaijan Gastroenterology and hepatology Association
Baku, Nasimi, AZ1018
About this study
Official title: The Prevalence of Gastroesophageal Reflux Disease in Azerbaijan
To evaluate the prevalence of Gastroesophageal reflux disease in Azerbaijan. It is intended to evaluate the prevalence of the disease in the regions as well as the capital by cluster sampling ,ethitology and to compare the outcomes depending on the geographical location.
Read the detailed description
It is an observational, nationwide study. The GERD questionnaire (1994) requested from Mayo clinic, was received and validated. The questionnaire was translated by 3 individuals from english to azeri and back trasnlated by 3 native english speakers.
Power analysis was performed. The research was presented for the approval to Ethical Committee of Azerbaijan Medical University.
Prior to the actual study, a pilot study with smaller number of participants was performed and the results were evaluated.
Cluster sampling methodology was provided by the statistical department of Azerbaijan Medical University.
110 employees were hired for using a survey in different regions of Azerbaijan. Written consent was obtained from every person evaluated. Statistical ananlysis was performed.
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- gastoesophageal reflux disease, prevalence, Azerbaijan
- Medical subject headings
- Gastroesophageal Reflux
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of GERD in Azerbaijan
The prevalence of GERD in Azerbaijan was 22.7% with significant female predominance (26.1% vs 15.3%; p<0.0001). GERD was defined in 17 % for ages below 35; 22.7 % for 36-55 and 38.5 % for those who are above 56 that, accordingly, indicating that GERD becomes significant as age increases (p<0.0001). Reflux was observed in 18.1% of normal weight respondents (BMI 18.6-24.9), 25.6% of overweight (BMI 25-29.9), and in 30.4% of obese (BMI>30) individuals (p=0.001). Regarding marital status, the prevalence was the lowest in the single subjects' group (17%), close to average in the married group (23.8%), and the highest (41.7%) in divorced/widowed cases (p=0.003). Stress was significantly affecting GERD distribution, affecting 59.4% of all respondents (p<0.004).
Measured: 1 year
GERD questionnaire (GERD) of Mayo case 1998- 019
Observational study
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start1 Jan 2018
- Primary completion1 Aug 2019
- Study completion1 Sep 2019
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.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Sevda Aghayeva
- Sponsor type
- University, hospital or other
- Collaborators
- Azerbaijan Medical University
- Responsible party
- Sponsor-investigator, Sevda Aghayeva, Azerbaijan Gastroenterology and Hepatology Association
- Investigators
- Sevda Aghayeva, MD, Principal investigator, Azerbaijan Gastroenterology and Hepatology Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616119
- Sponsor's protocol ID
- QastroHep
- Status last verified
- Dec 2022
- First submitted
- 29 Jul 2018
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Gastroesophageal Reflux Disease in Azerbaijan
- ClinicalTrials.gov ID
- NCT03616119
- Acronym / sponsor ID
- QastroHep
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- gastoesophageal reflux disease, prevalence, Azerbaijan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Sevda AghayevaUniversity, hospital or other
- Collaborators
- Azerbaijan Medical University
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 6 Aug 2018 (actual)
- 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 evaluate the prevalence of Gastroesophageal reflux disease in Azerbaijan. It is intended to evaluate the prevalence of the disease in the regions as well as the capital by cluster sampling ,ethitology and to compare the outcomes depending on the geographical location.
Detailed description
It is an observational, nationwide study. The GERD questionnaire (1994) requested from Mayo clinic, was received and validated. The questionnaire was translated by 3 individuals from english to azeri and back trasnlated by 3 native english speakers.
Power analysis was performed. The research was presented for the approval to Ethical Committee of Azerbaijan Medical University.
Prior to the actual study, a pilot study with smaller number of participants was performed and the results were evaluated.
Cluster sampling methodology was provided by the statistical department of Azerbaijan Medical University.
110 employees were hired for using a survey in different regions of Azerbaijan. Written consent was obtained from every person evaluated. Statistical ananlysis was performed.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Azerbaijan is divided by clusters with a definite numbers of individuals to take survey on reflux disease in the given age range and calculated by proportion of males and females.
Key inclusion criteria (5 listed)
- Age: 18-80
- Both genders
- Hearburn
- Belching
- Regurgitation
Key exclusion criteria (3 listed)
- protom pomp inhibitor use
- antibiotic use in the last 4 weeks
- upper GI surgery
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 prevalence of GERD in Azerbaijan
Time frame: 1 year
The prevalence of GERD in Azerbaijan was 22.7% with significant female predominance (26.1% vs 15.3%; p<0.0001). GERD was defined in 17 % for ages below 35; 22.7 % for 36-55 and 38.5 % for those who are above 56 that, accordingly, indicating that GERD becomes significant as age increases (p<0.0001). Reflux was observed in 18.1% of normal weight respondents (BMI 18.6-24.9), 25.6% of overweight (BMI 25-29.9), and in 30.4% of obese (BMI>30) individuals (p=0.001). Regarding marital status, the prevalence was the lowest in the single subjects' group (17%), close to average in the married group (23.8%), and the highest (41.7%) in divorced/widowed cases (p=0.003). Stress was significantly affecting GERD distribution, affecting 59.4% of all respondents (p<0.004).
GERD questionnaire (GERD) of Mayo case 1998- 019
Time frame: 1 year
Observational study
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 13 Dec 2022.
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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.
Sevda Aghayeva, MD principal investigator
Azerbaijan Gastroenterology and Hepatology Association
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 Gastroesophageal Reflux Disease, run by Sevda Aghayeva at 1 site in Azerbaijan.
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 5 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 13 Dec 2022. 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 Azerbaijan. 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 prevalence of GERD in Azerbaijan (time frame: 1 year). 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 13 Dec 2022.