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NCT01134367 Clinical Trial

An Epidemiological Study to Describe Symptom Control and Impact of Gastroesophageal Reflux Disease

GERD Clinical Trial

Official title:
An Epidemiological, Postmarketing Observational Study to Describe Symptom Control and Impact of Gastroesophageal Reflux Disease (GERD) on Patients' Daily Life

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01134367
Other study ID # NIS-GRS-DUM-2010/1
Secondary ID
Status Completed
Phase N/A
First received May 28, 2010
Last updated July 13, 2011
Start date May 2010
Est. completion date December 2010

Study information
Verified date July 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1000
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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)

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Serbia Research Site Belgrade
Serbia Research Site Leskovac
Serbia Research Site Nis
Serbia Research Site Novi Sad
Serbia Research Site Pancevo
Serbia Research Site Subotica
Serbia Research Site Zrenjanin

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Serbia, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Primary Epidemiological data in a population of GERD patients with disease duration = 3 years or newly diagnosed to include: Demographic data 8 weeks No
Primary 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 No
Primary 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 No
Secondary 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 No
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