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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01200550

Enrollment

1233

Registered

2010-09-13

Start date

2010-09-30

Completion date

2011-11-30

Last updated

2012-04-17

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

Conditions

Gastroesophageal Reflux Disease

Keywords

Gastroesophageal reflux disease, GERD Impact Scale

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Secondary

Measure	Time frame
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).

Countries

Bosnia and Herzegovina

Outcome results