The Use of International GerdQ Questionnaire

Gastroesophageal Reflux Disease Clinical Trial

— GERDq  

Official title:

Observational Non-interventional Study on the Use of International GerdQ Questionnaire for the Diagnosis of Gastroesophageal Reflux Disease in the Russian Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01489735
• Other study ID #: NIS-GRU-XXX-2011/1
• Status: Completed
• Phase: N/A
• First received: December 2, 2011
• Last updated: January 25, 2013
• Start date: February 2012
• Est. completion date: June 2012

Study information

• Verified date: January 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Independent Interdisciplinary Committee of ethical review of clinical trials
• Study type: Observational

Clinical 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). 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Locations

Country	Name	City	State
Russian Federation	Research site	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of GerdQ questionnaire = rate of GERD by GerdQ questionnaire (total score =8) / number of patients whose GERD was confirmed by instrumental examinations.		Up to 6 months	No
Primary	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		Up to 6 months	No
Secondary	Sensitivity of GERD diagnosis made by gastroenterologist = result of completion of GerdQ questionnaire / the results of clinical assessment by gastroenterologist.		Up to 6 months	No
Secondary	Frequency of GERD diagnosis based on instrumental examination (endoscopy, pH-metry) in studied patients.		Up to 6 months	No
Secondary	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.		Up to 6 months	No