The Use of International GerdQ Questionnaire

NCT01489735 | Completed

• 1 other identifier: NIS-GRU-XXX-2011/1
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastroesophageal Reflux Disease

Keywords

GERD; GERD Q QUESTIONNAIRE

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (3)

• Sensitivity of GERD diagnosis made by gastroenterologist = result of completion of GerdQ questionnaire / the results of clinical assessment by gastroenterologist.

  Up to 6 months

• Frequency of GERD diagnosis based on instrumental examination (endoscopy, pH-metry) in studied patients.

  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.

  Up to 6 months

Study Arms (1)

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

CLINICAL PRACTICE

You may qualify if:

• Signing of informed consent to participate in the study
• patients of both sexes, 18 years and older
• planned esophagogastroduodenoscopy

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research site

Moscow, Russia

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Alexey Stepanov, Prof

  AstraZeneca

  STUDY DIRECTOR

• Vladimir Ivashkin, Prof

  Head of Inner Disease Department of First Moscow State Medical University named after I.M. Sechenov

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2011
• First Posted: December 12, 2011
• Study Start: February 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: January 28, 2013

Record last verified: 2013-01

Locations

RU (1)