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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01200550
First received: September 7, 2010
Last updated: April 16, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition
Gastroesophageal Reflux Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Epidemiological, Observational Study to Describe Symptom Control and Impact on Daily Life in Patients With Gastroesophageal Reflux Disease (GERD)

Resource links provided by NLM:

MedlinePlus related topics: GERD
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]

Enrollment: 1233
Study Start Date: September 2010
Study Completion Date: November 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients previously diagnosed with GERD (disease duration =3 years) or newly diagnosed patients that are currently not treted with proton pump inhibitors, for whom GP or specialist (in primary care unit) have previosly decided to initiate or change treatment for GERD.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01200550

Locations
Bosnia and Herzegovina
Research Site
Banja Luka, Bosnia and Herzegovina
Research Site
Bijeljina, Bosnia and Herzegovina
Research Site
Derventa, Bosnia and Herzegovina
Research Site
Doboj, Bosnia and Herzegovina
Research Site
Gracanica, Bosnia and Herzegovina
Research Site
Gradacac, Bosnia and Herzegovina
Research Site
Gradiska, Bosnia and Herzegovina
Research Site
Hadzici, Bosnia and Herzegovina
Research Site
Jelah, Bosnia and Herzegovina
Research Site
Laktasi, Bosnia and Herzegovina
Research Site
Lukavac, Bosnia and Herzegovina
Research Site
Lukavica, Bosnia and Herzegovina
Research Site
Matuzici, Bosnia and Herzegovina
Research Site
Mostar, Bosnia and Herzegovina
Research Site
Pale, Bosnia and Herzegovina
Research Site
Prijedor, Bosnia and Herzegovina
Research Site
Sarajevo, Bosnia and Herzegovina
Research Site
Trn, Bosnia and Herzegovina
Research Site
Tuzla, Bosnia and Herzegovina
Research Site
Visoko, Bosnia and Herzegovina
Research Site
Vogosca, Bosnia and Herzegovina
Research Site
Zaluzani, Bosnia and Herzegovina
Research Site
Zivinice, Bosnia and Herzegovina
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Srdjan Gornjakovic, MD, PhD Clinical Center University of Sarajevo; Department of Gastrenterology and HepatologySarajevo
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01200550     History of Changes
Other Study ID Numbers: NIS-GBA-DUM-2010/1
Study First Received: September 7, 2010
Last Updated: April 16, 2012
Health Authority: Bosnia and Herzegovina: Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina (the Authority in the list is Federal Ministry of Health, but according to new law all study have to be approved by Agency)

Keywords provided by AstraZeneca:
Gastroesophageal reflux disease
GERD Impact Scale

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 21, 2013