The Use of International GerdQ Questionnaire (GERDq)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01489735
Recruitment Status : Completed
First Posted : December 12, 2011
Last Update Posted : January 28, 2013
Information provided by (Responsible Party):

December 2, 2011
December 12, 2011
January 28, 2013
February 2012
June 2012   (Final data collection date for 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 ]
  • 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 ]
Same as current
Complete list of historical versions of study NCT01489735 on Archive Site
  • 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 ]
Same as current
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The Use of International GerdQ Questionnaire
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.

Observational non-interventional study on the use of international GerdQ questionnaire for the diagnosis of gastroesophageal reflux disease in the Russian practice
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Gastroesophageal Reflux Disease
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2012
June 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Russian Federation
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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
January 2013