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

July 13, 2011 updated by: AstraZeneca

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

The purpose of this study is to examine patient's perspective of symptom control and impact of gastroesophageal reflux disease (GERD) on daily life.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Serbia
      • 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, Serbia
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

primary care clinics

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Patients with GERD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 8 weeks
8 weeks
Epidemiological data in a population of GERD patients with disease duration ≤ 3 years or newly diagnosed to include: Demographic data
Time Frame: 8 weeks
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
Time Frame: 8 weeks
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).
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

May 28, 2010

First Submitted That Met QC Criteria

June 1, 2010

First Posted (Estimate)

June 2, 2010

Study Record Updates

Last Update Posted (Estimate)

July 14, 2011

Last Update Submitted That Met QC Criteria

July 13, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-GRS-DUM-2010/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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