An Epidemiological Study to Describe Symptom Control and Impact of Gastroesophageal Reflux Disease
An Epidemiological, Postmarketing Observational Study to Describe Symptom Control and Impact of Gastroesophageal Reflux Disease (GERD) on Patients' Daily Life
1 other identifier
observational
1,000
1 country
7
Brief Summary
The purpose of this study is to examine patient's perspective of symptom control and impact of gastroesophageal reflux disease (GERD) on daily life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2010
Shorter than P25 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 28, 2010
CompletedFirst Posted
Study publicly available on registry
June 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJuly 14, 2011
July 1, 2011
7 months
May 28, 2010
July 13, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Epidemiological data in a population of GERD patients with disease duration ≤ 3 years or newly diagnosed to include: Typical GERD symptoms (indicating frequency and severity of symptoms) and signs
8 weeks
Epidemiological data in a population of GERD patients with disease duration ≤ 3 years or newly diagnosed to include: Demographic data
8 weeks
Epidemiological data in a population of GERD patients with disease duration ≤ 3 years or newly diagnosed to include: Treatments for GERD and treatment changes
8 weeks
Epidemiological data in a population of GERD patients with disease duration ≤ 3 years or newly diagnosed to include: Patient's perspective of symptom control and impact on daily life assessed using a patient-questionnaire (GIS-GERD Impact Scale).
8 weeks
Secondary Outcomes (1)
To evaluate the added value of a patient questionnaire (GIS-GERD Impact Scale) as a useful tool for the initial and long-term management of GERD patients: determination of the appropriate treatment and evaluation of the response to treatment
8 weeks
Study Arms (1)
1
Patients with GERD
Eligibility Criteria
primary care clinics
You may qualify if:
- Patients with gastroesophageal reflux disease -GERD (disease duration ≤3 years or newly diagnosed) that are currently not treated with a proton pump inhibitor, for whom the general practitioner (GP) has previously decided to initiate or change the tre
- Patients should be treated for GERD according to current practice (National guideline for treatment of dyspepsia in GP setting)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (7)
Research Site
Belgrade, Serbia
Research Site
Leskovac, Serbia
Research Site
Niš, Serbia
Research Site
Novi Sad, Serbia
Research Site
Pančevo, Serbia
Research Site
Subotica, Serbia
Research Site
Zrenjanin, Serbia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Miodrag Krstić, Prof.Dr
Institute for Gastroenterology, Clinical Center of Serbia, Belgrade
- PRINCIPAL INVESTIGATOR
Dragomir Damjanov, Prof. Dr
Clinic for Internal Diseases, Clinical Center of Vojvodina, Novi Sad
- PRINCIPAL INVESTIGATOR
Aleksandar Nagorni, Prof. Dr
Clinic for Internal Diseases- Gastroenterology Dept, Clinical Center Nis
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 28, 2010
First Posted
June 2, 2010
Study Start
May 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
July 14, 2011
Record last verified: 2011-07