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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00545883
First received: October 15, 2007
Last updated: January 25, 2012
Last verified: January 2012
History of Changes
  Purpose

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
GERD

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 of GERD in Patients With Erosive Gastroesophageal Reflux Disease.

Resource links provided by NLM:

MedlinePlus related topics: GERD
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To gather epidemiological data in a population of GERD patients [ Time Frame: After collection of all questionnaires ] [ Designated as safety issue: No ]

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

Enrollment: 2001
Study Start Date: June 2006
Study Completion Date: March 2008
  Eligibility

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

Primary & Specialty care units

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545883

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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00545883     History of Changes
Other Study ID Numbers: NIS-GBE-NEX-2006/1
Study First Received: October 15, 2007
Last Updated: January 25, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by AstraZeneca:
GERD
esophagitis
PPI

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

ClinicalTrials.gov processed this record on October 17, 2012