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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:
ClinicalTrials.gov Identifier:
NCT00963144
First Posted: August 21, 2009
Last Update Posted: October 21, 2010
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:
AstraZeneca
  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:


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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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:

  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): 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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00963144     History of Changes
Other Study ID Numbers: NIS-GMY-DUM-2009/1
First Submitted: August 12, 2009
First Posted: August 21, 2009
Last Update Posted: October 21, 2010
Last Verified: October 2010

Keywords provided by AstraZeneca:
Gerd Questionnaire

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


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