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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:
ClinicalTrials.gov Identifier:
NCT01200550
First Posted: September 13, 2010
Last Update Posted: April 17, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  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:


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 ]
  • 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) ]
  • 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) ]
  • 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 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). ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01200550     History of Changes
Other Study ID Numbers: NIS-GBA-DUM-2010/1
First Submitted: September 7, 2010
First Posted: September 13, 2010
Last Update Posted: April 17, 2012
Last Verified: April 2012

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