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Clinical Trials/NCT01134367
NCT01134367
Completed
N/A

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

AstraZeneca1 site in 1 country1,000 target enrollmentMay 2010
ConditionsGERD

Overview

Phase
N/A
Intervention
Not specified
Conditions
GERD
Sponsor
AstraZeneca
Enrollment
1000
Locations
1
Primary Endpoint
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
Status
Completed
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2010
End Date
December 2010
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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)

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Epidemiological data in a population of GERD patients with disease duration ≤ 3 years or newly diagnosed to include: Demographic data

Time Frame: 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

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

Secondary Outcomes

  • 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 Sites (1)

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