The Use of International GerdQ Questionnaire (GERDq)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01489735
First received: December 2, 2011
Last updated: January 25, 2013
Last verified: January 2013

December 2, 2011
January 25, 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01489735 on ClinicalTrials.gov 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 ] [ Designated as safety issue: No ]
  • Frequency of GERD diagnosis based on instrumental examination (endoscopy, pH-metry) in studied patients. [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

CLINICAL PRACTICE

Gastroesophageal Reflux Disease
Not Provided
1
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT01489735
NIS-GRU-XXX-2011/1
No
AstraZeneca
AstraZeneca
Not Provided
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
AstraZeneca
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP