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

Completed

• Conditions: GERD

• Registration Number: NCT01134367
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-28
• Study First Submitted QC: 2010-06-01
• Study First Posted: 2010-06-02
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-13
• Last Update Posted: 2011-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇷🇸 Zrenjanin, Serbia