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OpenTrials
Completed

NCT Number: NCT01200550

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

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.

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Key information

Conditions

Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Banja Luka, Bosnia and Herzegovina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Epidemiological data: To assess frequency and severity of typical GERD symptoms in newly diagnosed GERD patients and GERD patients with disease duration =3 years

    Time frame: Maximum of 14 weeks, with 3 visits in total

  2. Epidemiological data: To assess frequency and severity of typical GERD symptoms in newly diagnosed GERD patients and GERD patients with disease duration =3 years

    Time frame: Visit 1 (enrolment)

  3. Epidemiological data: To assess frequency and severity of typical GERD symptoms in newly diagnosed GERD patients and GERD patients with disease duration =3 years

    Time frame: Visit 2 (4-6 weeks after Visit 1)

  4. Epidemiological data: To assess frequency and severity of typical GERD symptoms in newly diagnosed GERD patients and GERD patients with disease duration =3 years

    Time frame: Visit 3 (8-14 weeks after Visit 1).

Secondary outcomes

  1. The evaluation of GERD Impact Scale (GIS questionnaire) as a useful tool for initial and long term management of GERD patients

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 13, 2010
Registry last updated
Apr 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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