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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01134367

Enrollment

1000

Registered

2010-06-02

Start date

2010-05-31

Completion date

2010-12-31

Last updated

2011-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GERD

Keywords

gastroesophageal reflux disease (GERD)

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

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	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

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	8 weeks

Countries

Serbia

Outcome results