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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
History of Changes
  Purpose

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
Gastroesophageal Reflux Disease

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: GERD
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 150
Study Start Date: February 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)

Detailed Description:

Observational non-interventional study on the use of international GerdQ questionnaire for the diagnosis of gastroesophageal reflux disease in the Russian practice

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

CLINICAL PRACTICE

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01489735

Locations
Russian Federation
Research site
Moscow, Russian Federation
Sponsors and Collaborators
AstraZeneca
Investigators
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
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01489735     History of Changes
Other Study ID Numbers: NIS-GRU-XXX-2011/1
Study First Received: December 2, 2011
Last Updated: January 25, 2013
Health Authority: Russia: Independent Interdisciplinary Committee of ethical review of clinical trials

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

ClinicalTrials.gov processed this record on May 19, 2013