The Use of International GerdQ Questionnaire (GERDq)
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ClinicalTrials.gov Identifier: NCT01489735 |
Recruitment Status
:
Completed
First Posted
: December 12, 2011
Last Update Posted
: January 28, 2013
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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.
Condition or disease |
---|
Gastroesophageal Reflux Disease |
Study Type : | Observational |
Actual Enrollment : | 150 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Observational Non-interventional Study on the Use of International GerdQ Questionnaire for the Diagnosis of Gastroesophageal Reflux Disease in the Russian Practice |
Study Start Date : | February 2012 |
Actual Primary Completion Date : | June 2012 |
Actual Study Completion Date : | June 2012 |

Group/Cohort |
---|
1 |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Signing of informed consent to participate in the study
- patients of both sexes, 18 years and older
- planned esophagogastroduodenoscopy
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01489735
Russian Federation | |
Research site | |
Moscow, Russian Federation |
Study Director: | Alexey Stepanov, Prof | AstraZeneca | |
Principal Investigator: | Vladimir Ivashkin, Prof | Head of Inner Disease Department of First Moscow State Medical University named after I.M. Sechenov |
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT01489735 History of Changes |
Other Study ID Numbers: |
NIS-GRU-XXX-2011/1 |
First Posted: | December 12, 2011 Key Record Dates |
Last Update Posted: | January 28, 2013 |
Last Verified: | January 2013 |
Keywords provided by AstraZeneca:
GERD GERD Q QUESTIONNAIRE |
Additional relevant MeSH terms:
Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders |
Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases |