We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Impact of GERD on Daily Life (NIS) (Alegria)

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.
ClinicalTrials.gov Identifier: NCT00545883
Recruitment Status : Completed
First Posted : October 17, 2007
Last Update Posted : January 26, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
The aim of this study is to gather epidemiological data in a population of GERD patients in primary care with a history of erosive esophagitis (less than or equal to 3 years).

Condition or disease

Study Design

Study Type : Observational
Actual Enrollment : 2001 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Epidemiological, Observational Study to Describe Symptom Control and Impact on Daily Life of GERD in Patients With Erosive Gastroesophageal Reflux Disease.
Study Start Date : June 2006
Study Completion Date : March 2008
Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. To gather epidemiological data in a population of GERD patients [ Time Frame: After collection of all questionnaires ]

Secondary Outcome Measures :
  1. To evaluate the added value of a new patient questionnaire (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. [ Time Frame: After collection of all questionnaires ]

Eligibility Criteria

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:   Non-Probability Sample
Study Population
Primary & Specialty care units

Inclusion Criteria:

  • Patients with erosive esophagitis (endoscopical findings according to the Los Angeles Classification; grade A-D) currently not treated with a proton pump inhibitor, for whom the general practitioner (GP) has decided to initiate or change the treatment for GERD
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): NCT00545883

  Show 112 Study Locations
Sponsors and Collaborators
Principal Investigator: E. Louis, PR ULG
More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00545883     History of Changes
Other Study ID Numbers: NIS-GBE-NEX-2006/1
First Posted: October 17, 2007    Key Record Dates
Last Update Posted: January 26, 2012
Last Verified: January 2012

Keywords provided by AstraZeneca: