The Use of International GerdQ Questionnaire (GERDq)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01489735
First received: December 2, 2011
Last updated: January 25, 2013
Last verified: January 2013
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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:
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 (Adult, Senior) |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01489735
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
| 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 September 23, 2016