Gastroesophageal Reflux DiseaseGERDqNCT01489735
The Use of International GerdQ Questionnaire
An observational study of Gastroesophageal Reflux Disease, run by AstraZeneca at 1 site in Russia.
Trial summary
There are three main directions for use GerdQ in practice. First of all, GerdQ can be used to diagnose GERD with an accuracy comparable to the accuracy of diagnosis of GERD by the specialist (gastroenterologist). 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
- 150 participants
- Where
- 1 siteRussia
- Study dates
- Feb 2012to Jun 2012
- 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: CLINICAL PRACTICE
Who may be able to join
- Signing of informed consent to participate in the study
- patients of both sexes, 18 years and older
- planned esophagogastroduodenoscopy
Who cannot join
- Surgical intervention for upper digestive tract (surgery for gastroesophageal reflux disease, peptic ulcer disease, etc.) In the past
- the presence of contraindications for esophagogastroduodenoscopy or pH-metry
- refusal to sign informed consent
- acceptance of antisecretory drugs (proton pump inhibitors, h2-receptor blockers), antacids and prokinetics for 7 days before enrollment
- Pregnancy
- Confirmed or suspected malignancy
- Impairment of the mental sphere
- Acceptance of nsaids (including acetylsalicylic acid at a dose of 150 mg / day), cytostatics, antibiotics (tetracyclines, lincosamides) at enrollment and during the preceding 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Non-interventional Study on the Use of International GerdQ Questionnaire for the Diagnosis of Gastroesophageal Reflux Disease in the Russian Practice
There are three main directions for use GerdQ in practice. First of all, GerdQ can be used to diagnose GERD with an accuracy comparable to the accuracy of diagnosis of GERD by the specialist (gastroenterologist). Using GerdQ can evaluate the impact of disease on the patient's life and help in choosing treatment of GERD, as well as direct assessment of treatment efficacy.
In connection with mentioned above, this study is devoted to the estimation of possibility to use GerdQ in routine practice of Russian physicians.
Read the detailed description
Observational non-interventional study on the use of international GerdQ questionnaire for the diagnosis of gastroesophageal reflux disease in the Russian practice
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- GERD, GERD Q QUESTIONNAIRE
- 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 |
|---|---|---|
| 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of GerdQ questionnaire = rate of GERD by GerdQ questionnaire (total score ≥8) / number of patients whose GERD was confirmed by instrumental examinations.
Measured: Up to 6 months
Specificity of GerdQ questionnaire = rate of GERD by GerdQ questionnaire (total score <8) / number of patients whose GERD diagnosis was excluded on the basis of instrumental examination
Measured: Up to 6 months
Secondary outcomes (3)
Sensitivity of GERD diagnosis made by gastroenterologist = result of completion of GerdQ questionnaire / the results of clinical assessment by gastroenterologist.
Measured: Up to 6 months
Frequency of GERD diagnosis based on instrumental examination (endoscopy, pH-metry) in studied patients.
Measured: Up to 6 months
Prevalence of GERD with the completed GerdQ questionnaire, which corresponds to the proportion (%) of patients with a total score of ≥ 8 in the questionnaire, among study patients.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2011 (estimated)
- Study startFeb 2012
- Primary completionJun 2012
- Study completionJun 2012
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexey Stepanov, Prof, Study director, AstraZenecaVladimir Ivashkin, Prof, Principal investigator, Head of Inner Disease Department of First Moscow State Medical University named after I.M. Sechenov
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01489735
- Sponsor's protocol ID
- NIS-GRU-XXX-2011/1
- Acronym
- GERDq
- Status last verified
- Jan 2013
- First submitted
- 2 Dec 2011
- Last updated
- 28 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Non-interventional Study on the Use of International GerdQ Questionnaire for the Diagnosis of Gastroesophageal Reflux Disease in the Russian Practice
- ClinicalTrials.gov ID
- NCT01489735
- Acronym / sponsor ID
- GERDq / NIS-GRU-XXX-2011/1
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- GERD, GERD Q QUESTIONNAIRE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 12 Dec 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.
There are three main directions for use GerdQ in practice. First of all, GerdQ can be used to diagnose GERD with an accuracy comparable to the accuracy of diagnosis of GERD by the specialist (gastroenterologist). Using GerdQ can evaluate the impact of disease on the patient's life and help in choosing treatment of GERD, as well as direct assessment of treatment efficacy.
In connection with mentioned above, this study is devoted to the estimation of possibility to use GerdQ in routine practice of Russian physicians.
Detailed description
Observational non-interventional study on the use of international GerdQ questionnaire for the diagnosis of gastroesophageal reflux disease in the Russian practice
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CLINICAL PRACTICE
Key inclusion criteria (3 listed)
- Signing of informed consent to participate in the study
- patients of both sexes, 18 years and older
- planned esophagogastroduodenoscopy
Key exclusion criteria (8 listed)
- Surgical intervention for upper digestive tract (surgery for gastroesophageal reflux disease, peptic ulcer disease, etc.) In the past
- the presence of contraindications for esophagogastroduodenoscopy or pH-metry
- refusal to sign informed consent
- acceptance of antisecretory drugs (proton pump inhibitors, h2-receptor blockers), antacids and prokinetics for 7 days before enrollment
- Pregnancy
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
Sensitivity of GerdQ questionnaire = rate of GERD by GerdQ questionnaire (total score ≥8) / number of patients whose GERD was confirmed by instrumental examinations.
Time frame: Up to 6 months
Specificity of GerdQ questionnaire = rate of GERD by GerdQ questionnaire (total score <8) / number of patients whose GERD diagnosis was excluded on the basis of instrumental examination
Time frame: Up to 6 months
3 secondary outcomes
Sensitivity of GERD diagnosis made by gastroenterologist = result of completion of GerdQ questionnaire / the results of clinical assessment by gastroenterologist.
Time frame: Up to 6 months
Frequency of GERD diagnosis based on instrumental examination (endoscopy, pH-metry) in studied patients.
Time frame: Up to 6 months
Prevalence of GERD with the completed GerdQ questionnaire, which corresponds to the proportion (%) of patients with a total score of ≥ 8 in the questionnaire, among study patients.
Time frame: Up to 6 months
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 28 Jan 2013.
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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.
Alexey Stepanov, Prof study director
AstraZeneca
Vladimir Ivashkin, Prof principal investigator
Head of Inner Disease Department of First Moscow State Medical University named after I.M. Sechenov
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 AstraZeneca at 1 site in Russia.
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 8 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 28 Jan 2013. 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 Russia. 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?
Sensitivity of GerdQ questionnaire = rate of GERD by GerdQ questionnaire (total score ≥8) / number of patients whose GERD was confirmed by instrumental examinations. (time frame: Up to 6 months). 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 28 Jan 2013.