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Diagnosis and Response to Treatment Using a Reliable Gastroesophageal Reflux Disease (GERD) Questionnaire: An In Clinical Practice Study (GQS)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00963144
First received: August 12, 2009
Last updated: October 20, 2010
Last verified: October 2010
History of Changes
  Purpose

The purpose of the study is to determine the applicability and utility of Gerd Q in the diagnosis of GERD and in the assessment of treatment response.


Condition
Gastroesophageal Reflux Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnosis and Response to Treatment Using a Reliable Gerd Questionnaire-an In Clinical Practise Study

Resource links provided by NLM:

MedlinePlus related topics: GERD
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To determine the applicability and utility of Gerd Q in the diagnosis of GERD and assessment of treatment response [ Time Frame: The applicability and utility of the Gerd Questionnaire will be done on 2 vists- Day 1 and Day 30 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess and monitor the treatment response of patients diagnosed with GERD [ Time Frame: The monitoring and assessment of treatment response using the Gerd Questionnaire will be done on 2 vists-Day 1 and Day 30 ] [ Designated as safety issue: No ]

Enrollment: 250
Study Start Date: July 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary care clinic

Criteria

Inclusion Criteria:

  • Patients of either gender aged between 18-79 years of age
  • Patients must be having symptoms of gastroesophageal reflux disease

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00963144

Locations
Malaysia
Research Site
Kuala Lumpur, Malaysia
Research Site
Selangor, Malaysia
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Goh Khean Lee, MBBS, MRCP, FRCP Faculty of Medicine, University of Malaya Medical Center (UMMC),
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00963144     History of Changes
Other Study ID Numbers: NIS-GMY-DUM-2009/1
Study First Received: August 12, 2009
Last Updated: October 20, 2010
Health Authority: Malaysia: Ministry of Health

Keywords provided by AstraZeneca:
Gerd Questionnaire

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 16, 2013