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NCT01200550 Clinical Trial

The Study to Describe Symptom Control and Impact on Daily Life in Gastroesophageal Reflux Disease (GERD) Patients

Gastroesophageal Reflux Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01200550
Other study ID # NIS-GBA-DUM-2010/1
Secondary ID
Status Completed
Phase N/A
First received September 7, 2010
Last updated April 16, 2012
Start date September 2010
Est. completion date November 2011

Study information
Verified date April 2012
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Bosnia and Herzegovina: Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina (the Authority in the list is Federal Ministry of Health, but according to new law all study have to be approved by Agency)
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate symptoms control and impact on daily life from patients perspective using specific GERD Impact Scale(GIS) questionnaire. The another objective is to obtain local epidemiological data for Bosnia and Herzegovina regarding GERD treatment in primary care.

Recruitment information / eligibility
Status Completed
Enrollment 1233
Est. completion date November 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients previously diagnosed with GERD (disease duration =3 years) or newly diagnosed patients that are currently not treated with proton pump inhibitor, for whom specialist or General Practionaire (GP) have previously decided to initiate or change treatment for GERD; Patients should be treated for GERD according to current practice

Exclusion Criteria:

- Females of childbearing potential should not be pregnant or nursing

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Bosnia and Herzegovina Research Site Banja Luka
Bosnia and Herzegovina Research Site Bijeljina
Bosnia and Herzegovina Research Site Derventa
Bosnia and Herzegovina Research Site Doboj
Bosnia and Herzegovina Research Site Gracanica
Bosnia and Herzegovina Research Site Gradacac
Bosnia and Herzegovina Research Site Gradiska
Bosnia and Herzegovina Research Site Hadzici
Bosnia and Herzegovina Research Site Jelah
Bosnia and Herzegovina Research Site Laktasi
Bosnia and Herzegovina Research Site Lukavac
Bosnia and Herzegovina Research Site Lukavica
Bosnia and Herzegovina Research Site Matuzici
Bosnia and Herzegovina Research Site Mostar
Bosnia and Herzegovina Research Site Pale
Bosnia and Herzegovina Research Site Prijedor
Bosnia and Herzegovina Research Site Sarajevo
Bosnia and Herzegovina Research Site Trn
Bosnia and Herzegovina Research Site Tuzla
Bosnia and Herzegovina Research Site Visoko
Bosnia and Herzegovina Research Site Vogosca
Bosnia and Herzegovina Research Site Zaluzani
Bosnia and Herzegovina Research Site Zivinice

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Bosnia and Herzegovina, 

Outcome
Type Measure Description Time frame Safety issue
Primary Epidemiological data: To assess frequency and severity of typical GERD symptoms in newly diagnosed GERD patients and GERD patients with disease duration =3 years Maximum of 14 weeks, with 3 visits in total No
Primary Epidemiological data: To assess frequency and severity of typical GERD symptoms in newly diagnosed GERD patients and GERD patients with disease duration =3 years Visit 1 (enrolment) No
Primary Epidemiological data: To assess frequency and severity of typical GERD symptoms in newly diagnosed GERD patients and GERD patients with disease duration =3 years Visit 2 (4-6 weeks after Visit 1) No
Primary Epidemiological data: To assess frequency and severity of typical GERD symptoms in newly diagnosed GERD patients and GERD patients with disease duration =3 years Visit 3 (8-14 weeks after Visit 1). No
Secondary The evaluation of GERD Impact Scale (GIS questionnaire) as a useful tool for initial and long term management of GERD patients Maximum of 14 weeks, with 3 visits in total: Visit 1 (enrolment), Visit 2 (4-6 weeks after Visit 1) and Visit 3 (8-14 weeks after Visit 1). No
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